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Cantharidin Application in Molluscum Patients-1 (CAMP-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: NCT03377790
Recruitment Status : Completed
First Posted : December 19, 2017
Results First Posted : December 14, 2021
Last Update Posted : January 11, 2022
Sponsor:
Collaborators:
Instat Consulting, Inc.
Paidion Research, Inc.
Database Integrations, 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
Condition Molluscum Contagiosum
Interventions Combination Product: VP-102 - Cantharidin, Topical Film Forming Solution
Combination Product: Placebo -Topical Film Forming Solution without VP-102
Enrollment 266
Recruitment Details Pre-study screening for eligibility (ICF and assent, [when applicable], demographics, physical exam, prior and concomitant meds and molluscum and medical hx) could occur up to 14 days before, or on the same day as Study drug application. Subjects not meeting criteria at Treatment Visit 1 were to be discontinued and treated per standard of care. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.
Pre-assignment Details  
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Period Title: Overall Study
Started 160 106
Completed 150 100
Not Completed 10 6
Reason Not Completed
Withdrawal by Subject             1             0
Adverse Event             1             0
Lost to Follow-up             0             2
Randomized but not treated             1             0
Withdrawn by Parent/Guardian             7             4
Arm/Group Title VP-102 Placebo Total
Hide Arm/Group Description

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Total of all reporting groups
Overall Number of Baseline Participants 160 106 266
Hide Baseline Analysis Population Description
ITT Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 160 participants 106 participants 266 participants
7.5  (5.29) 6.3  (4.67) 7.4  (5.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 106 participants 266 participants
Female
85
  53.1%
61
  57.5%
146
  54.9%
Male
75
  46.9%
45
  42.5%
120
  45.1%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 106 participants 266 participants
Hispanic or Latino
20
  12.5%
8
   7.5%
28
  10.5%
Not Hispanic or Latino
140
  87.5%
98
  92.5%
238
  89.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 160 participants 106 participants 266 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
4
   2.5%
1
   0.9%
5
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
10
   6.3%
5
   4.7%
15
   5.6%
White
135
  84.4%
98
  92.5%
233
  87.6%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
11
   6.9%
2
   1.9%
13
   4.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 160 participants 106 participants 266 participants
160 106 266
Baseline number of treatable molluscum lesions  
Mean (Standard Deviation)
Unit of measure:  Molluscum lesions
Number Analyzed 160 participants 106 participants 266 participants
22.2  (23.12) 24.8  (24.97) 23.2  (23.86)
1.Primary Outcome
Title Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
Hide Description Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).
Time Frame Day 1 (Baseline and new) compared to Day 84 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 160 106
Measure Type: Count of Participants
Unit of Measure: Participants
74
  46.3%
19
  17.9%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments Differences between treatments arms are compared using a chi-square test.
Method Chi-squared
Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
Hide Description Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit.
Time Frame Day 1 (Baseline and new) compared to Day 63
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 160 106
Measure Type: Count of Participants
Unit of Measure: Participants
51
  31.9%
18
  17.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method Chi-squared
Comments Differences between treatments arms are compared using a chi-square test.
3.Secondary Outcome
Title Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
Hide Description Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.
Time Frame Day 1 (Baseline and new) compared to Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 160 106
Measure Type: Count of Participants
Unit of Measure: Participants
33
  20.6%
10
   9.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0152
Comments [Not Specified]
Method Chi-squared
Comments Differences between treatments arms are compared using a chi-square test.
4.Secondary Outcome
Title Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
Hide Description Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.
Time Frame Day 1 (Baseline and new) compared to Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 160 106
Measure Type: Count of Participants
Unit of Measure: Participants
18
  11.3%
4
   3.8%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0302
Comments [Not Specified]
Method Chi-squared
Comments Differences between treatments arms are compared using a chi-square test.
5.Other Pre-specified Outcome
Title Change From Baseline to EOS Day 84 of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age.
Hide Description

Change from Baseline to EOS Day 84 of the Composite Score From the Children's Dermatology Life Quality Index (CDLQI) Assessment at the EOS Visit to Measure the Quality of Life and Impact of Skin Disease in the Subset of Subjects 4 -16 Years of Age.

From responses to that questionnaire, a composite score was calculated. The calculated composite score was the sum of the individual 10 items of the CDLQI and could range from 0-30. For each item on the

CDLQI, a score of 0-3 was assigned using the following scores per response:

  • 3: Very much (or Prevented School, Question 7 only)
  • 2: Quite a lot
  • 1: Only a little
  • 0: Not at all Larger composite CDLQI scores indicate skin condition is having more effect on subjects' lives (worse outcome).
Time Frame Baseline to Day 84 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population (Subjects 4-16 years of age)
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 122 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
-2.1  (2.70) -2.7  (3.46)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5921
Comments [Not Specified]
Method ANCOVA
Comments Differences between Tx arms are compared using an ANCOVA with treatment as the independent factor and baseline CDLQI composite score as the covariate.
6.Other Pre-specified Outcome
Title Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit
Hide Description Percent change of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit.
Time Frame Day 1 (Baseline) compared to Day 84 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 157 104
Mean (Standard Deviation)
Unit of Measure: percentage of change in wart count
-69.2  (98.13) 20.0  (239.72)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.
7.Other Pre-specified Outcome
Title Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
Hide Description Change from baseline in the number of treatable molluscum lesions (baseline and new) at the EOS visit.
Time Frame Day 1 (Baseline) compared to Day 84 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 157 104
Mean (Standard Deviation)
Unit of Measure: change in wart count
-18.3  (22.64) -5.9  (33.33)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments Differences between treatment arms are compared using an ANCOVA, with treatment as the independent factor and baseline lesion count as the covariate.
8.Other Pre-specified Outcome
Title Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
Hide Description Percentage of subjects that exhibited a 75% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit.
Time Frame Day 1 (Baseline) compared to Day 84 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 160 106
Measure Type: Count of Participants
Unit of Measure: Participants
119
  74.4%
36
  34.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments Differences between treatments arms are compared using a chi-square test.
9.Other Pre-specified Outcome
Title Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
Hide Description Percentage of subjects that exhibited a 90% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit.
Time Frame Day 1 (Baseline) compared to Day 84 (EOS)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 160 106
Measure Type: Count of Participants
Unit of Measure: Participants
99
  61.9%
28
  26.4%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Chi-squared
Comments Differences between treatments arms are compared using a chi-square test.
10.Other Pre-specified Outcome
Title Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject.
Hide Description Subject reported spread to household members as measured by any new occurrence of molluscum in household members of subject. To be eligible for assessment, subjects had to have at least one household member free of lesions at baseline and have at least 1 post baseline assessment of spread of molluscum lesions.
Time Frame Days 1, 21, 42, 63 and 84 (EOS).
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description:

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

Overall Number of Participants Analyzed 160 106
Measure Type: Count of Participants
Unit of Measure: Participants
9
   5.6%
13
  12.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection VP-102, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0520
Comments [Not Specified]
Method Chi-squared
Comments Differences between treatments arms are compared using a chi-square test.
Time Frame Treatment Visit 1 up to 30 days after EOS Day Visit.
Adverse Event Reporting Description

Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship.

Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE.

Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)

 
Arm/Group Title VP-102 Placebo
Hide Arm/Group Description

VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days

VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions

Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days

Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions

All-Cause Mortality
VP-102 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/161 (0.00%)      0/104 (0.00%)    
Hide Serious Adverse Events
VP-102 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/161 (0.00%)      1/104 (0.96%)    
Surgical and medical procedures     
Serious Treatment Emergent Adverse Events  1 [1]  0/161 (0.00%)  0 1/104 (0.96%)  1
1
Term from vocabulary, MedDRA
Indicates events were collected by systematic assessment
[1]
Appendicectomy
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VP-102 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   159/161 (98.76%)      76/104 (73.08%)    
Infections and infestations     
Pharyngitis streptococcal  1  6/161 (3.73%)  6/104 (5.77%) 
Injury, poisoning and procedural complications     
Application site pain  1  110/161 (68.32%)  20/104 (19.23%) 
Application site oedema  1  21/161 (13.04%)  6/104 (5.77%) 
Skin and subcutaneous tissue disorders     
Application site pruritus  1  104/161 (64.60%)  38/104 (36.54%) 
Application site erythema  1  69/161 (42.86%)  30/104 (28.85%) 
Application site scab  1  62/161 (38.51%)  25/104 (24.04%) 
Application site discolouration  1  54/161 (33.54%)  18/104 (17.31%) 
Application site dryness  1  24/161 (14.91%)  11/104 (10.58%) 
Application site erosion  1  10/161 (6.21%)  2/104 (1.92%) 
Application site scar  1  7/161 (4.35%)  5/104 (4.81%) 
Pruritus  1  4/161 (2.48%)  5/104 (4.81%) 
Application site vesicles  1  157/161 (97.52%)  29/104 (27.88%) 
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
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
Layout table for additonal information
Responsible Party: Verrica Pharmaceuticals Inc.
ClinicalTrials.gov Identifier: NCT03377790    
Other Study ID Numbers: VP-102-101
First Submitted: December 13, 2017
First Posted: December 19, 2017
Results First Submitted: October 12, 2021
Results First Posted: December 14, 2021
Last Update Posted: January 11, 2022