Trial Outcomes & Findings for Cantharidin Application in Molluscum Patients (NCT NCT03377803)
NCT ID: NCT03377803
Last Updated: 2021-12-14
Results Overview
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
262 participants
Primary outcome timeframe
Day 1 (Baseline) compared to Day 84 (EOS)
Results posted on
2021-12-14
Participant Flow
Participant milestones
| Measure |
VP-102
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
112
|
|
Overall Study
COMPLETED
|
139
|
108
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cantharidin Application in Molluscum Patients
Baseline characteristics by cohort
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Total
n=262 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.4 years
STANDARD_DEVIATION 7.97 • n=5 Participants
|
7.3 years
STANDARD_DEVIATION 6.68 • n=7 Participants
|
7.4 years
STANDARD_DEVIATION 7.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
115 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
81 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
112 Participants
n=5 Participants
|
87 Participants
n=7 Participants
|
199 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 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
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
142 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
246 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
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
150 participants
n=5 Participants
|
112 participants
n=7 Participants
|
262 participants
n=5 Participants
|
|
Baseline Number of Molluscum Lesions
|
18.7 Molluscum lesions
STANDARD_DEVIATION 22.93 • n=5 Participants
|
20.3 Molluscum lesions
STANDARD_DEVIATION 19.29 • n=7 Participants
|
19.4 Molluscum lesions
STANDARD_DEVIATION 21.43 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline) compared to Day 84 (EOS)Population: ITT Population
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 84 visit (EOS).
Outcome measures
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
|
81 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) compared to Day 63Population: ITT Population
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 63 visit.
Outcome measures
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
|
42 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) compared to Day 42Population: ITT Population
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 42 visit.
Outcome measures
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
|
19 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline) compared to Day 21Population: ITT Population
Percentage of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.
Outcome measures
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
|
8 Participants
|
2 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline), 21, 42, 63 and Day 84 (EOS)Population: ITT Population (Subjects 4-16 years of age)
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).
Outcome measures
| Measure |
VP-102
n=113 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=84 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Change From Baseline 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
Day 63
|
-2.0 score on a scale
Standard Deviation 3.28
|
-1.6 score on a scale
Standard Deviation 3.04
|
|
Change From Baseline 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
Day 84 (EOS)
|
-2.1 score on a scale
Standard Deviation 3.34
|
-1.9 score on a scale
Standard Deviation 3.35
|
|
Change From Baseline 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
Day 42
|
-1.5 score on a scale
Standard Deviation 3.20
|
-1.4 score on a scale
Standard Deviation 2.82
|
|
Change From Baseline 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
Day 21
|
-1.0 score on a scale
Standard Deviation 3.31
|
-1.2 score on a scale
Standard Deviation 3.17
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) compared to Day 84 (EOS)Population: ITT Population
Percent change of all treatable molluscum lesions (baseline and new) from baseline at the EOS visit.
Outcome measures
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit
|
-83.3 percentage change from Baseline
Standard Deviation 43.13
|
-19.1 percentage change from Baseline
Standard Deviation 108.38
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) compared to Day 84 (EOS)Population: ITT Population
Change from baseline in the number of treatable molluscum lesions (baseline and new) at the EOS visit.
Outcome measures
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
|
-17.1 change in wart count from baseline
Standard Deviation 22.87
|
-10.9 change in wart count from baseline
Standard Deviation 20.14
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) compared to Day 84(EOS)Population: ITT Population
Percentage of subjects exhibiting a 75% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.
Outcome measures
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
|
122 Participants
|
40 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) compared to Day 84 (EOS)Population: ITT Population
Percentage of subjects exhibiting a 90% or greater reduction of all treatable molluscum lesions (baseline and new) at the EOS visit.
Outcome measures
| Measure |
VP-102
n=150 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit
|
105 Participants
|
31 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Days 1, 21, 42, 63 and 84 (EOS).Population: ITT Population
Subject reported spread to household members as measured by any new occurrence of molluscum in household members of subject.
Outcome measures
| Measure |
VP-102
n=146 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=109 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject
|
10 Participants
|
7 Participants
|
Adverse Events
VP-102
Serious events: 0 serious events
Other events: 143 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 74 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VP-102
n=150 participants at risk
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102 Active will be administered via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
Placebo
n=112 participants at risk
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo to be applied via the applicator to Molluscum lesions
Applicator: Used to apply the topical film forming Active or Placebo to Molluscum.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Application site vesicles
|
94.0%
141/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
30.4%
34/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
|
Skin and subcutaneous tissue disorders
Application site scab
|
56.7%
85/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
19.6%
22/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
43.3%
65/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
33.0%
37/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
|
Skin and subcutaneous tissue disorders
Application site erythema
|
46.7%
70/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
25.0%
28/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
|
Skin and subcutaneous tissue disorders
Application site dryness
|
26.0%
39/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
17.9%
20/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
|
Skin and subcutaneous tissue disorders
Application site discolouration
|
30.7%
46/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
8.0%
9/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
|
Skin and subcutaneous tissue disorders
Application site erosion
|
8.0%
12/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
0.00%
0/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
|
Injury, poisoning and procedural complications
Application site Pain
|
55.3%
83/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
14.3%
16/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
|
Injury, poisoning and procedural complications
Application site oedema
|
5.3%
8/150 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
3.6%
4/112 • Baseline Visit to EOS Visit 84 Days (12 weeks)
Only TEAEs were to be considered.
|
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