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A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts (CARE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03981822
Recruitment Status : Completed
First Posted : June 11, 2019
Results First Posted : September 22, 2021
Last Update Posted : September 22, 2021
Sponsor:
Collaborators:
Instat Consulting, Inc.
Paidion Research, Inc.
BioClinica, Inc.
Information provided by (Responsible Party):
Verrica Pharmaceuticals Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Condylomata Acuminata
Papillomavirus Infections
Skin Diseases, Viral
Skin Diseases, Infectious
Skin Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Warts
Interventions Combination Product: VP-102 and applicator
Combination Product: Placebo
Enrollment 105
Recruitment Details 2 groups from Part A were to be included in Part B based on Part A analysis.
Pre-assignment Details All subject numbers are based on ITT population. Participants in Part A 6-hour and 24-hour group were also included in Part B subject populations.
Arm/Group Title Part A: VP-102 2-hour Part A: VP-102 6-hour Group Part A: VP-102 24-hour Group Part A: Placebo Part B: VP-102 6-hour Part B: Placebo 6-hour Part B: VP-102 24-hour Part B: Placebo 24-hour
Hide Arm/Group Description VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. This includes 3 subjects that received placebo (1 each for the 2-hour; 6-hour and 24-hour) VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied. Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
Period Title: Overall Study
Started 5 5 5 3 25 23 22 17
Completed 5 3 4 3 17 17 16 12
Not Completed 0 2 1 0 8 6 6 5
Reason Not Completed
Lost to Follow-up             0             1             1             0             6             4             4             2
Withdrawal by Subject             0             1             0             0             0             1             0             2
COVID-19 Related             0             0             0             0             2             1             2             1
Arm/Group Title Part A: VP-102 2-hour Part A: VP-102 6-hour Part A: VP-102 24-hour Part A: Placebo Part B: VP-102 6-hour Part B: 6-hour-Placebo Part B: VP-102 24-hour Part B: 24-hour-Placebo Total
Hide Arm/Group Description VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments. VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments. VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments. VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments. Total of all reporting groups
Overall Number of Baseline Participants 5 5 5 3 25 23 22 17 105
Hide Baseline Analysis Population Description
ITT population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 5 participants 3 participants 25 participants 23 participants 22 participants 17 participants 105 participants
34.40  (9.915) 43.00  (8.246) 33.80  (5.263) 32.00  (3.606) 38.12  (10.138) 35.87  (7.973) 34.45  (7.526) 33.88  (6.470) 35.85  (8.260)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 3 participants 25 participants 23 participants 22 participants 17 participants 105 participants
Female
4
  80.0%
3
  60.0%
2
  40.0%
0
   0.0%
10
  40.0%
10
  43.5%
10
  45.5%
7
  41.2%
46
  43.8%
Male
1
  20.0%
2
  40.0%
3
  60.0%
3
 100.0%
15
  60.0%
13
  56.5%
12
  54.5%
10
  58.8%
59
  56.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 3 participants 25 participants 23 participants 22 participants 17 participants 105 participants
Hispanic or Latino
1
  20.0%
0
   0.0%
0
   0.0%
0
   0.0%
6
  24.0%
1
   4.3%
2
   9.1%
5
  29.4%
15
  14.3%
Not Hispanic or Latino
4
  80.0%
5
 100.0%
5
 100.0%
3
 100.0%
19
  76.0%
22
  95.7%
20
  90.9%
12
  70.6%
90
  85.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 5 participants 3 participants 25 participants 23 participants 22 participants 17 participants 105 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.3%
0
   0.0%
0
   0.0%
1
   1.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
2
  40.0%
0
   0.0%
1
  20.0%
0
   0.0%
6
  24.0%
8
  34.8%
1
   4.5%
6
  35.3%
24
  22.9%
White
3
  60.0%
5
 100.0%
3
  60.0%
3
 100.0%
19
  76.0%
12
  52.2%
21
  95.5%
11
  64.7%
77
  73.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
1
  20.0%
0
   0.0%
0
   0.0%
2
   8.7%
0
   0.0%
0
   0.0%
3
   2.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants 5 participants 5 participants 3 participants 25 participants 23 participants 22 participants 17 participants 105 participants
5 5 5 3 25 23 22 17 105
Baseline number of treatable external genital warts  
Mean (Standard Deviation)
Unit of measure:  Genital warts
Number Analyzed 5 participants 5 participants 5 participants 3 participants 25 participants 23 participants 22 participants 17 participants 105 participants
7  (5.568) 9.60  (12.012) 13.00  (8.276) 11.67  (12.423) 8.28  (6.380) 5.87  (3.684) 8.68  (5.489) 7.76  (6.897) 8.08  (6.395)
1.Primary Outcome
Title Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.
Hide Description Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.
Time Frame Compares baseline wart count to Day 84, end of treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Part B and A: Intent-to-Treat Population. Part B summary is pooled with its respective treatments from Part A.
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
11
  36.7%
1
   4.2%
9
  33.3%
0
   0.0%
No
19
  63.3%
23
  95.8%
18
  66.7%
18
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Description Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
Time Frame Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Hide Outcome Measure Data
Hide Analysis Population Description
Part B and A pooled - ITT population
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment Visit 2: Yes, Complete Clearance
1
   3.3%
0
   0.0%
4
  14.8%
0
   0.0%
Treatment Visit 3: Yes, Complete Clearance
4
  13.3%
0
   0.0%
8
  29.6%
2
  11.1%
Treatment Visit 4: Yes, Complete Clearance
6
  20.0%
0
   0.0%
7
  25.9%
0
   0.0%
Study Day 84 EOT: Yes, Complete Clearance
11
  36.7%
1
   4.2%
9
  33.3%
0
   0.0%
F/U Visit Day 112: Yes, Complete Clearance
9
  30.0%
2
   8.3%
8
  29.6%
2
  11.1%
F/U Visit Day 147: Yes, Complete Clearance
6
  20.0%
3
  12.5%
8
  29.6%
2
  11.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3642
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0967
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0648
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1357
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0190
Comments P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0048
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0075
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0539
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1638
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4766
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1588
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Description Proportion of subjects exhibiting 90% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
Time Frame Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment Visit 2: Incidence of >=90% Clearance: YES
1
   3.3%
0
   0.0%
4
  14.8%
0
   0.0%
Treatment Visit 3: Incidence of >=90% Clearance: YES
5
  16.7%
0
   0.0%
8
  29.6%
2
  11.1%
Treatment Visit 4: Incidence of >=90% Clearance: YES
7
  23.3%
0
   0.0%
7
  25.9%
0
   0.0%
Study Day 84 EOT: Incidence of >=90% Clearance: YES
14
  46.7%
2
   8.3%
11
  40.7%
0
   0.0%
F/U Visit Day 112: Incidence of >=90% Clearance: YES
11
  36.7%
2
   8.3%
9
  33.3%
2
  11.1%
F/U Visit Day 147: Incidence of >=90% Clearance: YES
9
  30.0%
3
  12.5%
9
  33.3%
2
  11.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3642
Comments P-value is based on the CMH test stratified by gender. Part B summary is pooled with its respective treatments from Part A.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0356
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0118
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0026
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0174
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1311
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0967
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1357
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0184
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0024
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1034
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1029
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
4.Secondary Outcome
Title Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Description Proportion of subjects exhibiting 75% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
Time Frame Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment Visit 2: Incidence of >=75% Clearance: YES
5
  16.7%
0
   0.0%
6
  22.2%
1
   5.6%
Treatment Visit 3: Incidence of >=75% Clearance: YES
8
  26.7%
0
   0.0%
14
  51.9%
2
  11.1%
Treatment Visit 4: Incidence of >=75% Clearance: YES
11
  36.7%
2
   8.3%
12
  44.4%
1
   5.6%
Study Day 84 EOT: Incidence of >=75% Clearance: YES
15
  50.0%
2
   8.3%
15
  55.6%
2
  11.1%
F/U Visit Day 112: Incidence of >=75% Clearance: YES
13
  43.3%
3
  12.5%
13
  48.1%
3
  16.7%
F/U Visit Day 147: Incidence of >=75% Clearance: YES
10
  33.3%
4
  16.7%
13
  48.1%
2
  11.1%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0356
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1477
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0062
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0046
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0177
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0054
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0013
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0034
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0156
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0367
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1746
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0123
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments P-value is based on the CMH test stratified by gender.
5.Secondary Outcome
Title Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Description

Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Number of warts present were recorded at each treatment visit as well as follow-up visits. For each post baseline treatment visit, the change in number of warts from baseline was calculated.
Time Frame Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Populations
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Mean (Standard Deviation)
Unit of Measure: Warts
Treatment Visit 2 Number Analyzed 28 participants 23 participants 23 participants 18 participants
-4.0  (4.95) -0.3  (1.11) -5.3  (4.25) 0.6  (30.07)
Treatment Visit 3 Number Analyzed 25 participants 23 participants 23 participants 15 participants
-4.4  (5.80) -1.1  (3.69) -6.3  (5.45) -0.5  (5.01)
Treatment Visit 4 Number Analyzed 25 participants 23 participants 18 participants 13 participants
-5.2  (4.72) -0.9  (3.98) -7.1  (5.09) 0.5  (5.17)
Study Day 84 EOT Visit Number Analyzed 21 participants 21 participants 20 participants 13 participants
-6.1  (5.24) -1.1  (4.92) -7.4  (6.37) 0.1  (5.12)
Follow up Day 112 Number Analyzed 21 participants 19 participants 19 participants 14 participants
-5.3  (5.21) -1.1  (5.33) -8.1  (5.54) -0.3  (4.39)
Follow-up Visit Day 147 EOS Number Analyzed 17 participants 17 participants 20 participants 12 participants
-5.0  (7.63) -1.2  (5.49) -7.9  (5.46) -0.1  (4.66)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0021
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, Tx by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -3.96
Confidence Interval (2-Sided) 95%
-5.41 to -1.24
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0150
Comments [Not Specified]
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.72
Confidence Interval (2-Sided) 95%
-5.95 to -0.66
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0011
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.31
Confidence Interval (2-Sided) 95%
-6.54 to -1.69
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0007
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.50
Confidence Interval (2-Sided) 95%
-8.25 to -2.32
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.15
Confidence Interval (2-Sided) 95%
-7.50 to -1.91
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0349
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -5.02
Confidence Interval (2-Sided) 95%
-6.78 to -0.26
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is based on MMRM mode
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -4.76
Confidence Interval (2-Sided) 95%
-7.47 to -2.85
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.00
Confidence Interval (2-Sided) 95%
-8.37 to -2.43
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.64
Confidence Interval (2-Sided) 95%
-9.65 to -4.12
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.49
Confidence Interval (2-Sided) 95%
-9.67 to -2.92
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Analysis based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.96
Confidence Interval (2-Sided) 95%
-9.89 to -3.57
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments Analysis based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -6.99
Confidence Interval (2-Sided) 95%
-10.20 to -2.94
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Description Percent Change from Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
Time Frame Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Mean (Standard Deviation)
Unit of Measure: Wart percentage change from Baseline
Treatment Visit 2 Number Analyzed 28 participants 23 participants 23 participants 18 participants
-41.4  (32.38) -6.2  (13.14) -58.5  (26.69) -2.6  (30.07)
Treatment Visit 3 Number Analyzed 25 participants 23 participants 23 participants 15 participants
-49.0  (37.18) -8.9  (44.46) -69.3  (34.03) -17.8  (49.79)
Treatment Visit 4 Number Analyzed 25 participants 23 participants 18 participants 13 participants
-65.8  (30.69) -5.1  (66.26) -77.3  (26.87) 0.6  (41.94)
Study Day 84 End of Treatment Visit Number Analyzed 21 participants 21 participants 20 participants 13 participants
-79.7  (34.27) -1.6  (78.34) -77.1  (38.66) -5.5  (47.98)
Follow up Day 112 Number Analyzed 21 participants 19 participants 19 participants 14 participants
-68.2  (43.20) 1.9  (91.11) -79.2  (28.36) -14.2  (49.60)
Follow up Visit Day 147 End of Study Number Analyzed 17 participants 17 participants 20 participants 12 participants
-42.5  (111.83) -6.0  (86.56) -79.6  (25.01) -12.9  (50.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -41.47
Confidence Interval (2-Sided) 95%
-51.31 to -20.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -50.95
Confidence Interval (2-Sided) 95%
-66.18 to -19.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -66.21
Confidence Interval (2-Sided) 95%
-88.15 to -35.87
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -79.37
Confidence Interval (2-Sided) 95%
-111.44 to -49.77
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -69.79
Confidence Interval (2-Sided) 95%
-103.17 to -35.25
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1033
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -41.22
Confidence Interval (2-Sided) 95%
-90.61 to 8.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -58.43
Confidence Interval (2-Sided) 95%
-73.26 to -39.39
Estimation Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -69.86
Confidence Interval (2-Sided) 95%
-81.61 to -28.80
Estimation Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -76.55
Confidence Interval (2-Sided) 95%
-107.19 to -45.61
Estimation Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments P-value is based on MMRM model with gender, treatment, visit, treatment by visit interaction, and baseline wart count as factors.
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -74.29
Confidence Interval (2-Sided) 95%
-102.96 to -31.55
Estimation Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -77.10
Confidence Interval (2-Sided) 95%
-110.32 to -32.78
Estimation Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0178
Comments P-value is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart count as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -77.52
Confidence Interval (2-Sided) 95%
-120.82 to -11.88
Estimation Comments [Not Specified]
7.Other Pre-specified Outcome
Title Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Description Proportion of subjects exhibiting reduction of ≥ 1 treatable wart from baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
Time Frame Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Measure Type: Count of Participants
Unit of Measure: Participants
Treatment Visit 2 Yes - at least 1 wart reduction from Baseline
22
  73.3%
6
  25.0%
23
  85.2%
6
  33.3%
No
8
  26.7%
18
  75.0%
4
  14.8%
12
  66.7%
Treatment Visit 3 Yes - at least 1 wart reduction from Baseline
20
  66.7%
10
  41.7%
21
  77.8%
7
  38.9%
No
10
  33.3%
14
  58.3%
6
  22.2%
11
  61.1%
Treatment Visit 4 Yes - at least 1 wart reduction from Baseline
23
  76.7%
10
  41.7%
17
  63.0%
4
  22.2%
No
7
  23.3%
14
  58.3%
10
  37.0%
14
  77.8%
Study Day 84 EOT Visit Yes - at least 1 wart reduction from Baseline
19
  63.3%
9
  37.5%
18
  66.7%
4
  22.2%
No
11
  36.7%
15
  62.5%
9
  33.3%
14
  77.8%
F/U Visit Day 112 Yes - at least 1 wart reduction from Baseline
17
  56.7%
10
  41.7%
18
  66.7%
5
  27.8%
No
13
  43.3%
14
  58.3%
9
  33.3%
13
  72.2%
F/U Visit Day 147 EOS Yes - at least 1 wart reduction from Baseline
13
  43.3%
8
  33.3%
19
  70.4%
5
  27.8%
No
17
  56.7%
16
  66.7%
8
  29.6%
13
  72.2%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0004
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0005
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0698
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0100
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0101
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0077
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0640
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0045
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2840
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0132
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4668
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0064
Comments P-value is based on the CMH test stratified by gender.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Other Pre-specified Outcome
Title Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study)
Hide Description Proportion of subjects who are clear at all three study visits, Study Day 84 (End of Treatment) Visit and remain clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study).
Time Frame Complete clearance compared from Day 84 to follow-up days 112 and 147.
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Measure Type: Count of Participants
Unit of Measure: Participants
Yes
5
  16.7%
0
   0.0%
7
  25.9%
0
   0.0%
No
25
  83.3%
24
 100.0%
20
  74.1%
18
 100.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0364
Comments [Not Specified]
Method Mantel Haenszel
Comments Stratified by gender
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0215
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Stratified by gender
9.Other Pre-specified Outcome
Title Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Description Change from baseline in total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
Time Frame Baseline to Study Day 84, Follow-up Visits at Days 112 and 147 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Mean (Standard Deviation)
Unit of Measure: mm^2
Study Day 84 (EOT) Number Analyzed 10 participants 20 participants 11 participants 13 participants
-52.60  (67.067) -23.64  (59.722) -72.87  (91.659) 1.60  (33.796)
Follow-up Day 112 Number Analyzed 12 participants 17 participants 11 participants 12 participants
-79.43  (99.679) -20.35  (53.289) -82.79  (71.750) 1.40  (39.963)
Follow-up Visit Day 147 (EOS) Number Analyzed 11 participants 14 participants 12 participants 10 participants
-59.28  (100.988) -6.02  (36.929) -68.78  (68.710) 2.21  (45.035)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1222
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -59.63
Confidence Interval (2-Sided) 95%
-76.10 to 9.23
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0403
Comments Analysis based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value - 69.51
Confidence Interval (2-Sided) 95%
-81.30 to -1.90
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0863
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -58.88
Confidence Interval (2-Sided) 95%
-77.79 to 5.33
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0428
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -62.13
Confidence Interval (2-Sided) 95%
-100.76 to -1.73
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0084
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -71.93
Confidence Interval (2-Sided) 95%
-110.46 to -17.00
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0273
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value -63.11
Confidence Interval (2-Sided) 95%
-103.08 to -6.35
Estimation Comments [Not Specified]
10.Other Pre-specified Outcome
Title Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Description Percent Change from baseline in the total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).
Time Frame Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour
Hide Arm/Group Description:
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Overall Number of Participants Analyzed 30 24 27 18
Mean (Standard Deviation)
Unit of Measure: Change from baseline in % of wart area
Study Day 84 (EOT) Number Analyzed 10 participants 20 participants 11 participants 13 participants
-46.0  (52.77) -22.3  (57.92) -64.2  (55.78) -7.3  (93.42)
Follow-up Day 112 Number Analyzed 12 participants 17 participants 11 participants 12 participants
-48.2  (54.67) -21.5  (64.54) -76.4  (12.33) 13.8  (129.61)
Follow-up Day 147 (EOS) Number Analyzed 11 participants 14 participants 12 participants 10 participants
-45.8  (71.37) -11.7  (52.52) -69.3  (16.44) 19.9  (138.49)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments Analysis is based on MMRM model
Statistical Test of Hypothesis P-Value 0.3083
Comments [Not Specified]
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value - 44.65
Confidence Interval (2-Sided) 95%
-69.96 to 22.47
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1686
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value - 55.80
Confidence Interval (2-Sided) 95%
-86.93 to 15.56
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A: VP-102 6-hour, Part B Pooled With Part A: Placebo 6-hour
Comments Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2384
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value - 38.06
Confidence Interval (2-Sided) 95%
-87.04 to 22.10
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0603
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value - 61.96
Confidence Interval (2-Sided) 95%
-103.37 to 2.27
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0109
Comments Analysis is based on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value - 74.87
Confidence Interval (2-Sided) 95%
-138.71 to -18.83
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Part B Pooled With Part A VP-102 24-hour, Part B Pooled With Part A: Placebo 24-hour
Comments Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0467
Comments Analysis is base on MMRM model
Method Mixed Models Analysis
Comments

MMRM model with gender, Tx, visit, treatment by visit interaction, and baseline wart area as factors.

An unstructured covariance model was used.
Method of Estimation Estimation Parameter LS mean difference
Estimated Value - 66.62
Confidence Interval (2-Sided) 95%
-127.64 to -0.99
Estimation Comments [Not Specified]
Time Frame Adverse Events (AEs) were collected following the first application of study drug through Study Day 147.
Adverse Event Reporting Description TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
 
Arm/Group Title Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour Part A: VP-102 2-hour Part A: Placebo 2-hour
Hide Arm/Group Description Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data will be summarized for both Part B pooled with Part A for the applicable treatments. Data summarized for VP-102 2-hour group. Data summarized for VP-102 2-hour group..
All-Cause Mortality
Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour Part A: VP-102 2-hour Part A: Placebo 2-hour
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)   0/22 (0.00%)   0/28 (0.00%)   0/20 (0.00%)   0/5 (0.00%)   0/1 (0.00%) 
Hide Serious Adverse Events
Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour Part A: VP-102 2-hour Part A: Placebo 2-hour
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/29 (3.45%)   1/22 (4.55%)   0/28 (0.00%)   1/20 (5.00%)   0/5 (0.00%)   0/1 (0.00%) 
Infections and infestations             
Pneumonia † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders             
Musculoskeletal chest pain † 1  1/29 (3.45%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/1 (0.00%) 
Psychiatric disorders             
Bipolar disorder † 1  0/29 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Part B Pooled With Part A: VP-102 6-hour Part B Pooled With Part A: Placebo 6-hour Part B Pooled With Part A VP-102 24-hour Part B Pooled With Part A: Placebo 24-hour Part A: VP-102 2-hour Part A: Placebo 2-hour
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   29/29 (100.00%)   15/22 (68.18%)   28/28 (100.00%)   9/20 (45.00%)   5/5 (100.00%)   0/1 (0.00%) 
Gastrointestinal disorders             
Nausea † 1  0/29 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/1 (0.00%) 
Vomiting † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Gastritis † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
General disorders             
Application site vesicles † 1  25/29 (86.21%)  0/22 (0.00%)  26/28 (92.86%)  1/20 (5.00%)  4/5 (80.00%)  0/1 (0.00%) 
Application site pain † 1  20/29 (68.97%)  3/22 (13.64%)  19/28 (67.86%)  4/20 (20.00%)  4/5 (80.00%)  0/1 (0.00%) 
Application site erythema † 1  14/29 (48.28%)  3/22 (13.64%)  19/28 (67.86%)  1/20 (5.00%)  2/5 (40.00%)  0/1 (0.00%) 
Application site pruritus † 1  14/29 (48.28%)  5/22 (22.73%)  10/28 (35.71%)  1/20 (5.00%)  1/5 (20.00%)  0/1 (0.00%) 
Application site scab † 1  13/29 (44.83%)  1/22 (4.55%)  14/28 (50.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Application site discolouration † 1  7/29 (24.14%)  4/22 (18.18%)  6/28 (21.43%)  0/20 (0.00%)  4/5 (80.00%)  0/1 (0.00%) 
Application site dryness † 1  7/29 (24.14%)  2/22 (9.09%)  6/28 (21.43%)  1/20 (5.00%)  1/5 (20.00%)  0/1 (0.00%) 
Application site erosion † 1  6/29 (20.69%)  0/22 (0.00%)  7/28 (25.00%)  0/20 (0.00%)  4/5 (80.00%)  0/1 (0.00%) 
Application site oedema † 1  3/29 (10.34%)  1/22 (4.55%)  7/28 (25.00%)  1/20 (5.00%)  3/5 (60.00%)  0/1 (0.00%) 
Application site exfoliation † 1  3/29 (10.34%)  2/22 (9.09%)  5/28 (17.86%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Infections and infestations             
Sinusitis † 1  3/29 (10.34%)  1/22 (4.55%)  0/28 (0.00%)  0/20 (0.00%)  0/5 (0.00%)  0/1 (0.00%) 
Tooth abscess † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/1 (0.00%) 
Abscess limb † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Nasopharyngitis † 1  0/29 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Vulvovaginal mycotic infection † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Injury, poisoning and procedural complications             
Toxicity to various agents † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/1 (0.00%) 
Musculoskeletal and connective tissue disorders             
Arthritis † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/1 (0.00%) 
Nervous system disorders             
Headache † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Psychiatric disorders             
Anxiety † 1  0/29 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/1 (0.00%) 
Depression † 1  0/29 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/1 (0.00%) 
Insomnia † 1  0/29 (0.00%)  1/22 (4.55%)  0/28 (0.00%)  1/20 (5.00%)  0/5 (0.00%)  0/1 (0.00%) 
Major Depression † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Suicide attempt † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Reproductive system and breast disorders             
Vulvovaginal pruritus † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
Surgical and medical procedures             
Umbilical hernia repair † 1  0/29 (0.00%)  0/22 (0.00%)  0/28 (0.00%)  0/20 (0.00%)  1/5 (20.00%)  0/1 (0.00%) 
1
Term from vocabulary, MedDRA 23.0
†
Indicates events were collected by systematic assessment
Due to logistical and/or scheduling difficulties related to the SARS-CoV-2 (coronavirus-19; COVID-19) pandemic during the course of the study, six subjects discontinued due to COVID-19 related reasons.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
PI is bound to terms and conditions of a Sponsored Clinical Trial Agreement which has strict confidentiality obligations running to Sponsor and broad provisions restricting PI's rights to publish or present any data or Study Results without Sponsor's express review consent and review.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susan Cutler, VP, Medical Affairs
Organization: Verrica Pharmaceuticals
Phone: 484-773-0898
EMail: scutler@verrica.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Verrica Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03981822    
Other Study ID Numbers: VP-102-104
First Submitted: June 6, 2019
First Posted: June 11, 2019
Results First Submitted: June 18, 2021
Results First Posted: September 22, 2021
Last Update Posted: September 22, 2021