Trial Outcomes & Findings for Cantharidin Application in Molluscum Patients-1 (NCT NCT03377790)
NCT ID: NCT03377790
Last Updated: 2022-01-11
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
266 participants
Primary outcome timeframe
Day 1 (Baseline and new) compared to Day 84 (EOS)
Results posted on
2022-01-11
Participant Flow
Pre-study screening for eligibility (ICF and assent, \[when applicable\], demographics, physical exam, prior and concomitant meds and molluscum and medical hx) could occur up to 14 days before, or on the same day as Study drug application. Subjects not meeting criteria at Treatment Visit 1 were to be discontinued and treated per standard of care. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.
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, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
106
|
|
Overall Study
COMPLETED
|
150
|
100
|
|
Overall Study
NOT COMPLETED
|
10
|
6
|
Reasons for withdrawal
| Measure |
VP-102
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Adverse Event
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
|
Overall Study
Randomized but not treated
|
1
|
0
|
|
Overall Study
Withdrawn by Parent/Guardian
|
7
|
4
|
Baseline Characteristics
Cantharidin Application in Molluscum Patients-1
Baseline characteristics by cohort
| Measure |
VP-102
n=160 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=106 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
Total
n=266 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
7.5 years
STANDARD_DEVIATION 5.29 • n=5 Participants
|
6.3 years
STANDARD_DEVIATION 4.67 • n=7 Participants
|
7.4 years
STANDARD_DEVIATION 5.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
85 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
140 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
238 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
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 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
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
135 Participants
n=5 Participants
|
98 Participants
n=7 Participants
|
233 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
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
160 participants
n=5 Participants
|
106 participants
n=7 Participants
|
266 participants
n=5 Participants
|
|
Baseline number of treatable molluscum lesions
|
22.2 molluscum lesions
STANDARD_DEVIATION 23.12 • n=5 Participants
|
24.8 molluscum lesions
STANDARD_DEVIATION 24.97 • n=7 Participants
|
23.2 molluscum lesions
STANDARD_DEVIATION 23.86 • n=5 Participants
|
PRIMARY outcome
Timeframe: Day 1 (Baseline and new) 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=160 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=106 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 84 Visit (EOS)
|
74 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline and new) 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=160 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=106 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 63 Visit
|
51 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline and new) 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=160 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=106 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Percentage of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 42 Visit
|
33 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Day 1 (Baseline and new) compared to Day 21Population: ITT Population
Proportion of subjects exhibiting complete clearance of all treatable molluscum lesions (baseline and new) on the Day 21 visit.
Outcome measures
| Measure |
VP-102
n=160 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=106 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Molluscum Lesions (Baseline and New) on the Day 21 Visit
|
18 Participants
|
4 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to 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=122 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=78 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
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.
|
-2.1 units on a scale
Standard Deviation 2.70
|
-2.7 units on a scale
Standard Deviation 3.46
|
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=157 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=104 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Percent Change of All Treatable Molluscum Lesions (Baseline and New) From Baseline at the EOS Visit
|
-69.2 percentage of change in wart count
Standard Deviation 98.13
|
20.0 percentage of change in wart count
Standard Deviation 239.72
|
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=157 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=104 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Change From Baseline in the Number of Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
|
-18.3 change in wart count
Standard Deviation 22.64
|
-5.9 change in wart count
Standard Deviation 33.33
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) compared to Day 84 (EOS)Population: ITT Population
Percentage of subjects that exhibited a 75% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit.
Outcome measures
| Measure |
VP-102
n=160 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=106 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Percentage of Subjects Exhibiting a 75% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
|
119 Participants
|
36 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 1 (Baseline) compared to Day 84 (EOS)Population: ITT Population
Percentage of subjects that exhibited a 90% or greater clearance of all treatable molluscum lesions (baseline and new) at the EOS visit.
Outcome measures
| Measure |
VP-102
n=160 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=106 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Percentage of Subjects Exhibiting a 90% or Greater Reduction of All Treatable Molluscum Lesions (Baseline and New) at the EOS Visit.
|
99 Participants
|
28 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. To be eligible for assessment, subjects had to have at least one household member free of lesions at baseline and have at least 1 post baseline assessment of spread of molluscum lesions.
Outcome measures
| Measure |
VP-102
n=160 Participants
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=106 Participants
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Subject Reported Spread to Household Members as Measured by Any New Occurrence of Molluscum in Household Members of Subject.
|
9 Participants
|
13 Participants
|
Adverse Events
VP-102
Serious events: 0 serious events
Other events: 159 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VP-102
n=161 participants at risk
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=104 participants at risk
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Surgical and medical procedures
Serious Treatment Emergent Adverse Events
|
0.00%
0/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
0.96%
1/104 • Number of events 1 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
Other adverse events
| Measure |
VP-102
n=161 participants at risk
VP-102 Film Forming Solution applied via a prefilled applicator to affected area every 21 days
VP-102: VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). VP-102 Active will be administered to Molluscum lesions
|
Placebo
n=104 participants at risk
Vehicle Film Forming Solution applied via a prefilled applicator to affected area every 21 days
Placebo: Placebo a single-use drug device combination product containing only the vehicle will be administered to Molluscum lesions
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Application site pruritus
|
64.6%
104/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
36.5%
38/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Skin and subcutaneous tissue disorders
Application site erythema
|
42.9%
69/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
28.8%
30/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Skin and subcutaneous tissue disorders
Application site scab
|
38.5%
62/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
24.0%
25/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Skin and subcutaneous tissue disorders
Application site discolouration
|
33.5%
54/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
17.3%
18/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Skin and subcutaneous tissue disorders
Application site dryness
|
14.9%
24/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
10.6%
11/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Skin and subcutaneous tissue disorders
Application site erosion
|
6.2%
10/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
1.9%
2/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Skin and subcutaneous tissue disorders
Application site scar
|
4.3%
7/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
4.8%
5/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.5%
4/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
4.8%
5/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Skin and subcutaneous tissue disorders
Application site vesicles
|
97.5%
157/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
27.9%
29/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Injury, poisoning and procedural complications
Application site pain
|
68.3%
110/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
19.2%
20/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Injury, poisoning and procedural complications
Application site oedema
|
13.0%
21/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
5.8%
6/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
|
Infections and infestations
Pharyngitis streptococcal
|
3.7%
6/161 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
5.8%
6/104 • Treatment Visit 1 up to 30 days after EOS Day Visit.
Note: Related TEAE= TEAEs with relationship of Definitely, Probably or Possibly Related or have a missing relationship. Note: A Local Skin Reaction TEAE is defined as any Targeted AE that was identified as a Related AE. Note: 2 subjects randomized to placebo received VP-102 were included in VP-102 for Safety. There was one subject randomized to VP-102 but not treated.)
|
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