Trial Outcomes & Findings for Cantharidin and Occlusion in Verruca Epithelium (NCT NCT03487549)
NCT ID: NCT03487549
Last Updated: 2024-11-27
Results Overview
Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
56 participants
Primary outcome timeframe
Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.
Results posted on
2024-11-27
Participant Flow
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.
Participant milestones
| Measure |
Cohort 1
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.
|
Cohort 2
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.
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
35
|
|
Overall Study
COMPLETED
|
17
|
33
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Cohort 1
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.
|
Cohort 2
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.
|
|---|---|---|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
Baseline Characteristics
Cantharidin and Occlusion in Verruca Epithelium
Baseline characteristics by cohort
| Measure |
VP-102 - Cohort 1
n=21 Participants
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.
|
VP-102 - Cohort 2
n=35 Participants
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
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
37.86 years
STANDARD_DEVIATION 21.247 • n=5 Participants
|
37.66 years
STANDARD_DEVIATION 16.435 • n=7 Participants
|
37.75 years
STANDARD_DEVIATION 18.212 • n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
35 participants
n=7 Participants
|
56 participants
n=5 Participants
|
|
Baseline wart count
|
2.19 Baseline wart count
STANDARD_DEVIATION 1.569 • n=5 Participants
|
1.65 Baseline wart count
STANDARD_DEVIATION 1.098 • n=7 Participants
|
1.85 Baseline wart count
STANDARD_DEVIATION 1.311 • n=5 Participants
|
PRIMARY outcome
Timeframe: Treatment Visit Day 1 (Baseline) compared to Day 84 (EOS) Visit.Population: ITT Population
Cohort 1: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOS Visit (Day 84).
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
Cohort 1: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
|
4 Participants
|
PRIMARY outcome
Timeframe: Compare Treatment Visit 1 (Baseline) to EOT Visit (Day 84)Population: ITT Population
Cohort 2: Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the EOT Visit (Day 84).
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
Cohort 2: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
|
18 Participants
|
SECONDARY outcome
Timeframe: Change in the number of warts compared at Baseline (Visit 1) to the End of Study Visit (Day 84).Population: ITT Population
Cohort 1: Change from baseline in the number of treatable warts (baseline and new) at the EOS Visit (Day 84).
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
Baseline
|
2.19 Number of warts
Standard Deviation 1.569
|
|
Cohort 1: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOS Visit (Day 84)
End of Treatment Visit
|
-0.95 Number of warts
Standard Deviation 1.658
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to End of Treatment Visit (Day 84).Population: ITT Population
Cohort 1: Assessing the percent change from Baseline in the number of treatable warts (Baseline and new) at the EOT visit (Day 84).
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
Cohort 1: Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit (Day 84).
|
-31.19 Percent change
Standard Deviation 42.776
|
SECONDARY outcome
Timeframe: Baseline, Day 14, 28, 42 and 84 (EOS)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.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
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
Complete Clearance Reported at any Visit?
|
5 Participants
|
|
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
Complete Clearance Reported at Day 14
|
0 Participants
|
|
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
Complete Clearance Reported at Day 28
|
2 Participants
|
|
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
Complete Clearance Reported at Day 42
|
5 Participants
|
|
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
Complete Clearance Reported at Day 84 (EOS)
|
4 Participants
|
SECONDARY outcome
Timeframe: Baseline, Day 84 (EOS)Population: ITT Population
Cohort 2: Change from baseline in the number of treatable warts (baseline and new) at the EOT Visit Day 84).
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
Cohort 2: Change From Baseline in the Number of Treatable Warts (Baseline and New) at the EOT Visit Day 84)
|
-0.85 change in wart count
Standard Deviation 1.064
|
SECONDARY outcome
Timeframe: Baseline (Visit 1) to End of Treatment Visit (Day 84).Population: ITT Population
Cohort 2: Change from baseline in the percent of treatable warts (baseline and new) at the EOT Visit (Day 84).
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
Cohort 2: Change From Baseline in the Percent of Treatable Warts (Baseline and New) at the EOT Visit (Day 84)
|
-53.79 percentage of change in wart count
Standard Deviation 55.241
|
SECONDARY outcome
Timeframe: Baseline, Day 21, 42, 63, and 84 (EOS), 105, 126, and 147Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
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
Complete Clearance Reported at Day 21 (Treatment Visit 2)
|
5 Participants
|
|
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
Complete Clearance Reported at Day 42 (Treatment Visit 3)
|
7 Participants
|
|
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
Complete Clearance Reported at Day 63 (Treatment Visit 4)
|
12 Participants
|
|
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
Complete Clearance Reported at Day 84 (EOT)
|
18 Participants
|
|
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
Complete Clearance Reported at Day 105
|
16 Participants
|
|
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
Complete Clearance Reported at Day 126
|
13 Participants
|
|
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
Complete Clearance Reported at Day 147
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14, 28, 42, and 84 (EOS)Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
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.
Treatment Visit 2 Day 14
|
-0.79 Percent change in number of warts
Standard Deviation 3.637
|
|
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.
Treatment Visit 3 Day 28
|
-12.30 Percent change in number of warts
Standard Deviation 30.462
|
|
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.
Treatment Visit 4 Day 42
|
-29.29 Percent change in number of warts
Standard Deviation 42.845
|
|
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.
EOS Day 84
|
-31.19 Percent change in number of warts
Standard Deviation 42.776
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14, 28, 42, and 84 (EOS)Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
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
Treatment Visit 2
|
-0.5 change in wart count
Standard Deviation 0.218
|
|
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
Treatment Visit 3
|
-0.43 change in wart count
Standard Deviation 1.326
|
|
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
Treatment Visit 4
|
-0.76 change in wart count
Standard Deviation 1.446
|
|
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
End of Study
|
-0.95 change in wart count
Standard Deviation 1.658
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Compare Treatment Visit 1 (Baseline) to End of Study (Day 84).Population: ITT Population
Cohort 1: Proportion of subjects exhibiting ≥ 50% clearance of all treatable warts (baseline and new) at the EOS visit as compared to baseline.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
Cohort 1: Proportion of Subjects Exhibiting ≥ 50% Clearance of All Treatable Warts (Baseline and New) at the EOS Visit as Compared to Baseline
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14, 28, 42, and 84 (EOS)Population: ITT Population
Cohort 1-Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOS compared to baseline.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
Cohort 1-Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOS Compared to Baseline
|
9 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14, 28, 42, and 84 (EOS)Population: ITT Population
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).
Outcome measures
| Measure |
Cohort 1
n=21 Participants
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.
|
|---|---|
|
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)
Reduction of >= 1 Wart from Baseline at any visit?
|
9 Participants
|
|
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)
Wart Reduction >= 1 Reported at Day 14 (Visit 2)
|
1 Participants
|
|
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)
Wart Reduction >= 1 Reported at Day 28 (Visit 3)
|
4 Participants
|
|
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)
Wart Reduction >= 1 Reported at Day 42 (Visit 4)
|
8 Participants
|
|
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)
Wart Reduction >= 1 Reported at Day 84 (EOS)
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Treatment Visits 2 (Day 21), 3 (Day 42), 4 (Day 63) through the End of Treatment (Day 84).Population: ITT population
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.
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
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.
Day 21 (Treatment Visit 2)
|
-18.18 percentage of change in wart count
Standard Deviation 37.119
|
|
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.
Day 42 (Treatment Visit 3)
|
-29.85 percentage of change in wart count
Standard Deviation 41.392
|
|
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.
Day 63 (Treatment Visit 4)
|
-37.12 percentage of change in wart count
Standard Deviation 53.078
|
|
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.
Day 84 (End of Treatment Visit)
|
-53.79 percentage of change in wart count
Standard Deviation 55.241
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14, 28, 42, and 84 (EOS)Population: ITT Population
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).
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
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)
Day 21 (Treatment Visit 2)
|
-0.39 change in wart count
Standard Deviation 0.998
|
|
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)
Day 42 (Treatment Visit 3)
|
-0.48 change in wart count
Standard Deviation 0.712
|
|
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)
Day 63 (Treatment Visit 4)
|
-0.52 change in wart count
Standard Deviation 0.712
|
|
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)
Day 84 (End of Treatment Visit)
|
-0.85 change in wart count
Standard Deviation 1.064
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 84 (EOT)Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
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
|
19 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to EOT (Day 84)Population: ITT Population
Cohort 2: Proportion of subjects who respond to treatment defined by a ≥ 50% reduction in total wart area at EOT compared to baseline.
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
Cohort 2: Proportion of Subjects Who Respond to Treatment Defined by a ≥ 50% Reduction in Total Wart Area at EOT Compared to Baseline
|
23 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Day 14, 28, 42, and 84 (EOS)Population: ITT Population
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).
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
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)
Day 21 (Treatment Visit 2)
|
7 Participants
|
|
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)
Day 42 (Treatment Visit 3)
|
13 Participants
|
|
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)
Day 63 (Treatment Visit 4)
|
15 Participants
|
|
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)
Day 84 (End of Treatment Visit)
|
20 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Treatment Visit 1 (Baseline) to each follow-up visit Day 105, Day 126 and Day 147.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.
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
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
Complete Clearance Reported at Day 105
|
16 Participants
|
|
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
Complete Clearance Reported at Day 126
|
13 Participants
|
|
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
Complete Clearance Reported at Day 147
|
13 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to follow-up visits on Day 105, Day 126 and Day 147Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
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
Day 105
|
-50.91 percentage change from Baseline
Standard Deviation 54.736
|
|
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
Day 126
|
-45.61 percentage change from Baseline
Standard Deviation 52.556
|
|
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
Day 147
|
-45.61 percentage change from Baseline
Standard Deviation 52.556
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baseline to Day 105, Day 126 and Day 147Population: ITT Population
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.
Outcome measures
| Measure |
Cohort 1
n=35 Participants
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.
|
|---|---|
|
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
Day 105
|
-0.82 change in wart count
Standard Deviation 0.983
|
|
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
Day 126
|
-0.73 change in wart count
Standard Deviation 0.911
|
|
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
Day 147
|
-0.73 change in wart count
Standard Deviation 0.911
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Cohort 2
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort 1
n=21 participants at risk
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.
|
Cohort 2
n=34 participants at risk；n=35 participants at risk
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.
|
|---|---|---|
|
General disorders
Application site vesicles
|
95.2%
20/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
79.4%
27/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site pain
|
95.2%
20/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
76.5%
26/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site erythema
|
61.9%
13/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
55.9%
19/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site pruritus
|
42.9%
9/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
47.1%
16/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site scab
|
38.1%
8/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
58.8%
20/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site dryness
|
28.6%
6/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
38.2%
13/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site oedema
|
19.0%
4/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
17.6%
6/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site discolouration
|
4.8%
1/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
23.5%
8/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site exfoliation
|
0.00%
0/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
11.8%
4/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
General disorders
Application site erosion
|
0.00%
0/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
8.8%
3/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/21 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
8.8%
3/34 • Cohort 1: Day of first treatment until Day 84 Cohort 2: Day of first treatment until Day 84, 105, 126, 147
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.
|
Additional Information
Susan Cutler, VP, Medical Affairs
Verrica Pharmaceuticals
Phone: 484-773-0898
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER