Cantharidin and Occlusion in Verruca Epithelium (COVE-1)

• ClinicalTrials.gov Identifier: NCT03487549
• Recruitment Status: Completed
• First Posted: April 4, 2018
• Results First Posted: September 1, 2021
• Last Update Posted: September 1, 2021
• Sponsor: Verrica Pharmaceuticals Inc.
• Collaborators: Instat Consulting, Inc.; Paidion Research, Inc.; BioClinica, Inc.; ALMAC Clinical Services
• Information provided by (Responsible Party): Verrica Pharmaceuticals Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Common Wart; Warts Hand; Warts; Papillomavirus Infections; DNA Virus Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Virus Diseases; Tumor Virus Infections; Verruca Vulgaris; Verruca
• Interventions: Combination Product: VP-102 Cantharidin topical film forming solution; Combination Product: VP-102 Cantharidin, topical film forming solution
• Enrollment: 56

Participant Flow

Recruitment Details	The protocol was originally designed with one- cohort, it was later modified to include two cohorts. Subjects in Cohort 1 completed enrollment prior to beginning enrollment of new Subjects into Cohort 2.
Pre-assignment Details

Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of at least 21 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. Paring of lesions was allowed. Subjects were 12 years and older.
Period Title: Overall Study
Started	21	35
Completed	17	33
Not Completed	4	2
Reason Not Completed
Protocol Violation	0	1
Lost to Follow-up	2	1
Withdrawal by Subject	2	0

Baseline Characteristics

Arm/Group Title		VP-102 - Cohort 1	VP-102 - Cohort 2	Total
Arm/Group Description		Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 14 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of at least 21 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. Paring of lesions was allowed. VP-102 Cantharidin topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.	Total of all reporting groups
Overall Number of Baseline Participants		21	35	56
Baseline Analysis Population Description		Study participants enrolled into Cohort 1 were not included in Cohort 2. New subjects were enrolled into Cohort 2.
Age, Categorical; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	35 participants	56 participants
	<=18 years	5	8	13
	Between 18 and 65 years	8	26	34
	>=65 years	8	1	9
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	21 participants	35 participants	56 participants
		37.86 (21.247)	37.66 (16.435)	37.75 (18.212)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	35 participants	56 participants
	Female	11 52.4%	22 62.9%	33 58.9%
	Male	10 47.6%	13 37.1%	23 41.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	21 participants	35 participants	56 participants
	Hispanic or Latino	1 4.8%	1 2.9%	2 3.6%
	Not Hispanic or Latino	20 95.2%	34 97.1%	54 96.4%
	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	21 participants	35 participants	56 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	1 2.9%	1 1.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	5 23.8%	0 0.0%	5 8.9%
	White	16 76.2%	34 97.1%	50 89.3%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	21 participants	35 participants	56 participants
		21	35	56
Baseline wart count; Mean (Standard Deviation); Unit of measure: Baseline wart count
	Number Analyzed	21 participants	35 participants	56 participants
		2.19 (1.569)	1.65 (1.098)	1.85 (1.311)

Outcome Measures

1. Primary Outcome

Title	Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Description	Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).
Time Frame	Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Measure Type: Count of Participants; Unit of Measure: Participants
	4 19.0%

2. Primary Outcome

Title	Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
Description	Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).
Time Frame	Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Measure Type: Count of Participants; Unit of Measure: Participants
	18 51.4%

3. Secondary Outcome

Title	Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Description	Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).
Time Frame	Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Mean (Standard Deviation); Unit of Measure: Number of warts
Baseline	2.19 (1.569)
End of Treatment Visit	-0.95 (1.658)

4. Secondary Outcome

Title	Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).
Description	Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).
Time Frame	Baseline (Visit 1) to End of Treatment Visit (Day 84).

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Mean (Standard Deviation); Unit of Measure: Percent change
	-31.19 (42.776)

5. Secondary Outcome

Title	Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
Description	Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and over the duration of the study.
Time Frame	Baseline, Day 14, 28, 42 and 84 (EOS)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Clearance Reported at any Visit?	5 23.8%
Complete Clearance Reported at Day 14	0 0.0%
Complete Clearance Reported at Day 28	2 9.5%
Complete Clearance Reported at Day 42	5 23.8%
Complete Clearance Reported at Day 84 (EOS)	4 19.0%

6. Secondary Outcome

Title	Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)
Description	Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).
Time Frame	Baseline, Day 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Mean (Standard Deviation); Unit of Measure: change in wart count
	-0.85 (1.064)

7. Secondary Outcome

Title	Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
Description	Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).
Time Frame	Baseline (Visit 1) to End of Treatment Visit (Day 84).

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Mean (Standard Deviation); Unit of Measure: percentage of change in wart count
	-53.79 (55.241)

8. Secondary Outcome

Title	Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts, (Baseline and New), at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study
Description	Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts, (baseline and new), at Visit 2, Visit 3, Visit 4 and over the duration of the study.
Time Frame	Baseline, Day 21, 42, 63, and 84 (EOS), 105, 126, and 147

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Clearance Reported at Day 21 (Treatment Visit 2)	5 14.3%
Complete Clearance Reported at Day 42 (Treatment Visit 3)	7 20.0%
Complete Clearance Reported at Day 63 (Treatment Visit 4)	12 34.3%
Complete Clearance Reported at Day 84 (EOT)	18 51.4%
Complete Clearance Reported at Day 105	16 45.7%
Complete Clearance Reported at Day 126	13 37.1%
Complete Clearance Reported at Day 147	13 37.1%

9. Other Pre-specified Outcome

Title	Cohort 1:Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over the Duration of the Study.
Description	Cohort 1: Percent change from baseline in the number of treatable warts (Baseline and new) from Baseline at Visit 2, Visit 3, Visit 4 and over the duration of the study.
Time Frame	Baseline, Day 14, 28, 42, and 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Mean (Standard Deviation); Unit of Measure: Percent change in number of warts
Treatment Visit 2 Day 14	-0.79 (3.637)
Treatment Visit 3 Day 28	-12.30 (30.462)
Treatment Visit 4 Day 42	-29.29 (42.845)
EOS Day 84	-31.19 (42.776)

10. Other Pre-specified Outcome

Title	Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Visit 2, Visit 3, Visit 4 and the EOS Visit
Description	Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at Visit 2, Visit 3, Visit 4 and the EOS Visit.
Time Frame	Baseline, Day 14, 28, 42, and 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Mean (Standard Deviation); Unit of Measure: change in wart count
Treatment Visit 2	-0.5 (0.218)
Treatment Visit 3	-0.43 (1.326)
Treatment Visit 4	-0.76 (1.446)
End of Study	-0.95 (1.658)

11. Other Pre-specified Outcome

Title	Cohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline
Description	Cohort 1: Proportion of subjects exhibiting ≥ 50% clearance of all treatable warts (baseline and new) at the EOS visit as compared to baseline.
Time Frame	Compare Treatment Visit 1 (Baseline) to End of Study (Day 84).

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Measure Type: Count of Participants; Unit of Measure: Participants
	7 33.3%

12. Other Pre-specified Outcome

Title	Cohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline
Description	Cohort 1-Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOS compared to baseline.
Time Frame	Baseline, Day 14, 28, 42, and 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Measure Type: Count of Participants; Unit of Measure: Participants
	9 42.9%

13. Other Pre-specified Outcome

Title	Cohort 1-Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84)
Description	Cohort 1-Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOS Visit (Day 84).
Time Frame	Baseline, Day 14, 28, 42, and 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	Cohort 1
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.
Overall Number of Participants Analyzed	21
Measure Type: Count of Participants; Unit of Measure: Participants
Reduction of >= 1 Wart from Baseline at any visit?	9 42.9%
Wart Reduction >= 1 Reported at Day 14 (Visit 2)	1 4.8%
Wart Reduction >= 1 Reported at Day 28 (Visit 3)	4 19.0%
Wart Reduction >= 1 Reported at Day 42 (Visit 4)	8 38.1%
Wart Reduction >= 1 Reported at Day 84 (EOS)	7 33.3%

14. Other Pre-specified Outcome

Title	Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Visit 2, Visit 3, Visit 4 and Over Duration of the Study.
Description	Cohort 2: Intent to Treat population Cohort 2-Percent reduction of all treatable warts (baseline and new) from baseline at Visit 2, Visit 3, Visit 4 and over duration of the study.
Time Frame	Baseline to Treatment Visits 2 (Day 21), 3 (Day 42), 4 (Day 63) through the End of Treatment (Day 84).

Outcome Measure Data

Analysis Population Description

ITT population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Mean (Standard Deviation); Unit of Measure: percentage of change in wart count
Day 21 (Treatment Visit 2)	-18.18 (37.119)
Day 42 (Treatment Visit 3)	-29.85 (41.392)
Day 63 (Treatment Visit 4)	-37.12 (53.078)
Day 84 (End of Treatment Visit)	-53.79 (55.241)

15. Other Pre-specified Outcome

Title	Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84)
Description	Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4 and the EOT Visit (Day 84).
Time Frame	Baseline, Day 14, 28, 42, and 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Mean (Standard Deviation); Unit of Measure: change in wart count
Day 21 (Treatment Visit 2)	-0.39 (0.998)
Day 42 (Treatment Visit 3)	-0.48 (0.712)
Day 63 (Treatment Visit 4)	-0.52 (0.712)
Day 84 (End of Treatment Visit)	-0.85 (1.064)

16. Other Pre-specified Outcome

Title	Cohort 2: Proportion of Subjects Exhibiting ≥ 50 % Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84) as Compared to Baseline
Description	Cohort 2: Proportion of subjects exhibiting ≥ 50 % clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84) as compared to baseline.
Time Frame	Baseline to Day 84 (EOT)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Measure Type: Count of Participants; Unit of Measure: Participants
	19 54.3%

17. Other Pre-specified Outcome

Title	Cohort 2: Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOT Compared to Baseline
Description	Cohort 2: Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOT compared to baseline.
Time Frame	Baseline to EOT (Day 84)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Measure Type: Count of Participants; Unit of Measure: Participants
	23 65.7%

18. Other Pre-specified Outcome

Title	Cohort 2: Proportion of Subjects Exhibiting Reduction of at Least 1 Treatable Wart From Baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84)
Description	Cohort 2: Proportion of subjects exhibiting reduction of at least 1 treatable wart from baseline at Visit 2, Visit 3, Visit 4 and at the EOT Visit (Day 84).
Time Frame	Baseline, Day 14, 28, 42, and 84 (EOS)

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Measure Type: Count of Participants; Unit of Measure: Participants
Day 21 (Treatment Visit 2)	7 20.0%
Day 42 (Treatment Visit 3)	13 37.1%
Day 63 (Treatment Visit 4)	15 42.9%
Day 84 (End of Treatment Visit)	20 57.1%

19. Other Pre-specified Outcome

Title	Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147
Description	Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.
Time Frame	Treatment Visit 1 (Baseline) to each follow-up visit Day 105, Day 126 and Day 147.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Measure Type: Count of Participants; Unit of Measure: Participants
Complete Clearance Reported at Day 105	16 45.7%
Complete Clearance Reported at Day 126	13 37.1%
Complete Clearance Reported at Day 147	13 37.1%

20. Other Pre-specified Outcome

Title	Cohort 2: Percent Reduction of All Treatable Warts (Baseline and New) From Baseline at Follow-up Visits on Day 105, Day 126 and Day 147
Description	Cohort 2: Percent reduction of all treatable warts (baseline and new) from baseline at follow-up visits on Day 105, Day 126 and Day 147.
Time Frame	Baseline to follow-up visits on Day 105, Day 126 and Day 147

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Mean (Standard Deviation); Unit of Measure: percentage change from Baseline
Day 105	-50.91 (54.736)
Day 126	-45.61 (52.556)
Day 147	-45.61 (52.556)

21. Other Pre-specified Outcome

Title	Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at Follow-up Visits on Day 105, Day 126 and Day 147
Description	Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at follow-up visits on Day 105, Day 126 and Day 147.
Time Frame	baseline to Day 105, Day 126 and Day 147

Outcome Measure Data

Analysis Population Description

ITT Population

Arm/Group Title	VP-102 - Cohort 2
Arm/Group Description:	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. VP-102 Cantharidin, topical film forming solution: VP-102 Cantharidin topical film forming solution. Treatment interval of at least 21 days between treatments. VP-102 Applicator: The applicator is used to apply the Study drug.The product is a combination therapy which includes the drug VP-102 and the applicator which is the device.
Overall Number of Participants Analyzed	35
Mean (Standard Deviation); Unit of Measure: change in wart count
Day 105	-0.82 (0.983)
Day 126	-0.73 (0.911)
Day 147	-0.73 (0.911)

Adverse Events

Time Frame	Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
Adverse Event Reporting Description	Treatment Emergent Adverse Events (TEAEs) are defined as those AEx that occurred after dosing and those existing AEs that worsened during the study. If it cannot be determined whether the AE is treatment emergent due to an incomplete onset date, the AE was considered treatment emergent. Local skin reactions to treatment were recorded as AEs.
Arm/Group Title	Cohort 1	Cohort 2
Arm/Group Description	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. utilized a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response. No paring of lesions was allowed. Subjects were 2 years and older.	Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator. Utilized a treatment interval of 21 days between treatments. Paring of lesions was allowed. Subjects were 12 years and older.
All-Cause Mortality
	Cohort 1	Cohort 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/21 (0.00%)	0/34 (0.00%)
Serious Adverse Events
	Cohort 1	Cohort 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/21 (0.00%)	0/35 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cohort 1	Cohort 2
	Affected / at Risk (%)	Affected / at Risk (%)
Total	20/21 (95.24%)	32/34 (94.12%)
General disorders
Application site vesicles * 1	20/21 (95.24%)	27/34 (79.41%)
Application site pain † 1 [1]	20/21 (95.24%)	26/34 (76.47%)
Application site erythema † 1 [2]	13/21 (61.90%)	19/34 (55.88%)
Application site pruritus † 1 [3]	9/21 (42.86%)	16/34 (47.06%)
Application site scab † 1 [4]	8/21 (38.10%)	20/34 (58.82%)
Application site dryness † 1 [5]	6/21 (28.57%)	13/34 (38.24%)
Application site oedema † 1 [6]	4/21 (19.05%)	6/34 (17.65%)
Application site discolouration † 1 [7]	1/21 (4.76%)	8/34 (23.53%)
Application site exfoliation † 1 [8]	0/21 (0.00%)	4/34 (11.76%)
Application site erosion † 1 [9]	0/21 (0.00%)	3/34 (8.82%)
Infections and infestations
Papilloma viral infection † 1 [10]	0/21 (0.00%)	3/34 (8.82%)
1 Term from vocabulary, MedDRA 20.0; * Indicates events were collected by non-systematic assessment; † Indicates events were collected by systematic assessment; [1] Application site pain; [2] Application site erythema; [3] Application site pruritus; [4] Application site scab; [5] Application site dryness; [6] Application site oedema; [7] Application site discolouration; [8] Application site exfoliation; [9] Application site erosion; [10] Papilloma viral infection

Limitations and Caveats

[Not Specified]

More Information

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

• 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):

Guenthner S, McFalda W, Kwong P, Eads K, McCafferty M, Rieger J, Glover DK, Willson C, Burnett P, Olivadoti M. COVE-1: A Phase 2, Open-Label Study to Evaluate Efficacy and Safety and the Optimal Regimen of VP-102, a Proprietary Drug-Device Product Containing Topical Cantharidin (0.7% w/v) Under Occlusion for the Treatment of Common Warts. Dermatol Ther (Heidelb). 2021 Oct;11(5):1623-1634. doi: 10.1007/s13555-021-00576-y. Epub 2021 Jul 21.

• Responsible Party: Verrica Pharmaceuticals Inc.
• ClinicalTrials.gov Identifier: NCT03487549
• Other Study ID Numbers: VP-102-105
• First Submitted: March 21, 2018
• First Posted: April 4, 2018
• Results First Submitted: June 7, 2021
• Results First Posted: September 1, 2021
• Last Update Posted: September 1, 2021