Trial Outcomes & Findings for A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts (NCT NCT03981822)

Last Updated: 2024-11-27

Results Overview

Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

105 participants

Primary outcome timeframe

Compares baseline wart count to Day 84, end of treatment.

Results posted on

2024-11-27

Participant Flow

2 groups from Part A were to be included in Part B based on Part A analysis.

All subject numbers are based on ITT population. Participants in Part A 6-hour and 24-hour group were also included in Part B subject populations.

Participant milestones

Participant milestones
Measure	Part A: VP-102 2-hour VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part A: VP-102 6-hour Group VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part A: VP-102 24-hour Group VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part A: Placebo This includes 3 subjects that received placebo (1 each for the 2-hour; 6-hour and 24-hour)	Part B: VP-102 6-hour VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part B: Placebo 6-hour Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part B: VP-102 24-hour VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part B: Placebo 24-hour Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
Overall Study STARTED	5	5	5	3	25	23	22	17
Overall Study COMPLETED	5	3	4	3	17	17	16	12
Overall Study NOT COMPLETED	0	2	1	0	8	6	6	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: VP-102 6-hour Group VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part A: VP-102 24-hour Group VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part B: VP-102 6-hour VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part B: Placebo 6-hour Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part B: VP-102 24-hour VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.	Part B: Placebo 24-hour Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
Overall Study Lost to Follow-up	1	1	6	4	4	2
Overall Study Withdrawal by Subject	1	0	0	1	0	2
Overall Study COVID-19 Related	0	0	2	1	2	1

Baseline Characteristics

A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: VP-102 2-hour n=5 Participants VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments.	Part A: VP-102 6-hour n=5 Participants VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.	Part A: VP-102 24-hour n=5 Participants VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.	Part A: Placebo n=3 Participants Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments.	Part B: VP-102 6-hour n=25 Participants VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.	Part B: 6-hour-Placebo n=23 Participants Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.	Part B: VP-102 24-hour n=22 Participants VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.	Part B: 24-hour-Placebo n=17 Participants Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.	Total n=105 Participants Total of all reporting groups
Age, Continuous	34.40 years STANDARD_DEVIATION 9.915 • n=5 Participants	43.00 years STANDARD_DEVIATION 8.246 • n=7 Participants	33.80 years STANDARD_DEVIATION 5.263 • n=5 Participants	32.00 years STANDARD_DEVIATION 3.606 • n=4 Participants	38.12 years STANDARD_DEVIATION 10.138 • n=21 Participants	35.87 years STANDARD_DEVIATION 7.973 • n=8 Participants	34.45 years STANDARD_DEVIATION 7.526 • n=8 Participants	33.88 years STANDARD_DEVIATION 6.470 • n=24 Participants	35.85 years STANDARD_DEVIATION 8.260 • n=42 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	10 Participants n=21 Participants	10 Participants n=8 Participants	10 Participants n=8 Participants	7 Participants n=24 Participants	46 Participants n=42 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	15 Participants n=21 Participants	13 Participants n=8 Participants	12 Participants n=8 Participants	10 Participants n=24 Participants	59 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	5 Participants n=24 Participants	15 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	5 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	19 Participants n=21 Participants	22 Participants n=8 Participants	20 Participants n=8 Participants	12 Participants n=24 Participants	90 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 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	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	6 Participants n=21 Participants	8 Participants n=8 Participants	1 Participants n=8 Participants	6 Participants n=24 Participants	24 Participants n=42 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	19 Participants n=21 Participants	12 Participants n=8 Participants	21 Participants n=8 Participants	11 Participants n=24 Participants	77 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	3 Participants n=42 Participants
Region of Enrollment United States	5 participants n=5 Participants	5 participants n=7 Participants	5 participants n=5 Participants	3 participants n=4 Participants	25 participants n=21 Participants	23 participants n=8 Participants	22 participants n=8 Participants	17 participants n=24 Participants	105 participants n=42 Participants
Baseline number of treatable external genital warts	7 genital warts STANDARD_DEVIATION 5.568 • n=5 Participants	9.60 genital warts STANDARD_DEVIATION 12.012 • n=7 Participants	13.00 genital warts STANDARD_DEVIATION 8.276 • n=5 Participants	11.67 genital warts STANDARD_DEVIATION 12.423 • n=4 Participants	8.28 genital warts STANDARD_DEVIATION 6.380 • n=21 Participants	5.87 genital warts STANDARD_DEVIATION 3.684 • n=8 Participants	8.68 genital warts STANDARD_DEVIATION 5.489 • n=8 Participants	7.76 genital warts STANDARD_DEVIATION 6.897 • n=24 Participants	8.08 genital warts STANDARD_DEVIATION 6.395 • n=42 Participants

PRIMARY outcome

Timeframe: Compares baseline wart count to Day 84, end of treatment.

Population: Part B and A: Intent-to-Treat Population. Part B summary is pooled with its respective treatments from Part A.

Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. No	19 Participants	23 Participants	18 Participants	18 Participants
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. Yes	11 Participants	1 Participants	9 Participants	0 Participants

SECONDARY outcome

Timeframe: Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

Population: Part B and A pooled - ITT population

Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 2: Yes, Complete Clearance	1 Participants	0 Participants	4 Participants	0 Participants
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 3: Yes, Complete Clearance	4 Participants	0 Participants	8 Participants	2 Participants
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 4: Yes, Complete Clearance	6 Participants	0 Participants	7 Participants	0 Participants
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 EOT: Yes, Complete Clearance	11 Participants	1 Participants	9 Participants	0 Participants
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 112: Yes, Complete Clearance	9 Participants	2 Participants	8 Participants	2 Participants
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 147: Yes, Complete Clearance	6 Participants	3 Participants	8 Participants	2 Participants

SECONDARY outcome

Timeframe: Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

Population: ITT Population

Proportion of subjects exhibiting 90% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 2: Incidence of >=90% Clearance: YES	1 Participants	0 Participants	4 Participants	0 Participants
Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 3: Incidence of >=90% Clearance: YES	5 Participants	0 Participants	8 Participants	2 Participants
Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 4: Incidence of >=90% Clearance: YES	7 Participants	0 Participants	7 Participants	0 Participants
Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 EOT: Incidence of >=90% Clearance: YES	14 Participants	2 Participants	11 Participants	0 Participants
Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 112: Incidence of >=90% Clearance: YES	11 Participants	2 Participants	9 Participants	2 Participants
Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 147: Incidence of >=90% Clearance: YES	9 Participants	3 Participants	9 Participants	2 Participants

SECONDARY outcome

Timeframe: Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

Population: ITT Population

Proportion of subjects exhibiting 75% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 2: Incidence of >=75% Clearance: YES	5 Participants	0 Participants	6 Participants	1 Participants
Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 3: Incidence of >=75% Clearance: YES	8 Participants	0 Participants	14 Participants	2 Participants
Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 4: Incidence of >=75% Clearance: YES	11 Participants	2 Participants	12 Participants	1 Participants
Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 EOT: Incidence of >=75% Clearance: YES	15 Participants	2 Participants	15 Participants	2 Participants
Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 112: Incidence of >=75% Clearance: YES	13 Participants	3 Participants	13 Participants	3 Participants
Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 147: Incidence of >=75% Clearance: YES	10 Participants	4 Participants	13 Participants	2 Participants

SECONDARY outcome

Timeframe: Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

Population: ITT Populations

Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS). Number of warts present were recorded at each treatment visit as well as follow-up visits. For each post baseline treatment visit, the change in number of warts from baseline was calculated.

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 2	-4.0 Warts Standard Deviation 4.95	-0.3 Warts Standard Deviation 1.11	-5.3 Warts Standard Deviation 4.25	0.6 Warts Standard Deviation 30.07
Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 3	-4.4 Warts Standard Deviation 5.80	-1.1 Warts Standard Deviation 3.69	-6.3 Warts Standard Deviation 5.45	-0.5 Warts Standard Deviation 5.01
Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 4	-5.2 Warts Standard Deviation 4.72	-0.9 Warts Standard Deviation 3.98	-7.1 Warts Standard Deviation 5.09	0.5 Warts Standard Deviation 5.17
Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 EOT Visit	-6.1 Warts Standard Deviation 5.24	-1.1 Warts Standard Deviation 4.92	-7.4 Warts Standard Deviation 6.37	0.1 Warts Standard Deviation 5.12
Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Follow up Day 112	-5.3 Warts Standard Deviation 5.21	-1.1 Warts Standard Deviation 5.33	-8.1 Warts Standard Deviation 5.54	-0.3 Warts Standard Deviation 4.39
Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Follow-up Visit Day 147 EOS	-5.0 Warts Standard Deviation 7.63	-1.2 Warts Standard Deviation 5.49	-7.9 Warts Standard Deviation 5.46	-0.1 Warts Standard Deviation 4.66

SECONDARY outcome

Timeframe: Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

Population: ITT Population

Percent Change from Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 2	-41.4 Wart percentage change from Baseline Standard Deviation 32.38	-6.2 Wart percentage change from Baseline Standard Deviation 13.14	-58.5 Wart percentage change from Baseline Standard Deviation 26.69	-2.6 Wart percentage change from Baseline Standard Deviation 30.07
Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 3	-49.0 Wart percentage change from Baseline Standard Deviation 37.18	-8.9 Wart percentage change from Baseline Standard Deviation 44.46	-69.3 Wart percentage change from Baseline Standard Deviation 34.03	-17.8 Wart percentage change from Baseline Standard Deviation 49.79
Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 4	-65.8 Wart percentage change from Baseline Standard Deviation 30.69	-5.1 Wart percentage change from Baseline Standard Deviation 66.26	-77.3 Wart percentage change from Baseline Standard Deviation 26.87	0.6 Wart percentage change from Baseline Standard Deviation 41.94
Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 End of Treatment Visit	-79.7 Wart percentage change from Baseline Standard Deviation 34.27	-1.6 Wart percentage change from Baseline Standard Deviation 78.34	-77.1 Wart percentage change from Baseline Standard Deviation 38.66	-5.5 Wart percentage change from Baseline Standard Deviation 47.98
Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Follow up Day 112	-68.2 Wart percentage change from Baseline Standard Deviation 43.20	1.9 Wart percentage change from Baseline Standard Deviation 91.11	-79.2 Wart percentage change from Baseline Standard Deviation 28.36	-14.2 Wart percentage change from Baseline Standard Deviation 49.60
Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Follow up Visit Day 147 End of Study	-42.5 Wart percentage change from Baseline Standard Deviation 111.83	-6.0 Wart percentage change from Baseline Standard Deviation 86.56	-79.6 Wart percentage change from Baseline Standard Deviation 25.01	-12.9 Wart percentage change from Baseline Standard Deviation 50.49

OTHER_PRE_SPECIFIED outcome

Timeframe: Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.

Population: ITT population

Proportion of subjects exhibiting reduction of ≥ 1 treatable wart from baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 2 · Yes - at least 1 wart reduction from Baseline	22 Participants	6 Participants	23 Participants	6 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 2 · No	8 Participants	18 Participants	4 Participants	12 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 3 · Yes - at least 1 wart reduction from Baseline	20 Participants	10 Participants	21 Participants	7 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 3 · No	10 Participants	14 Participants	6 Participants	11 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 4 · Yes - at least 1 wart reduction from Baseline	23 Participants	10 Participants	17 Participants	4 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Treatment Visit 4 · No	7 Participants	14 Participants	10 Participants	14 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 EOT Visit · Yes - at least 1 wart reduction from Baseline	19 Participants	9 Participants	18 Participants	4 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 EOT Visit · No	11 Participants	15 Participants	9 Participants	14 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 112 · Yes - at least 1 wart reduction from Baseline	17 Participants	10 Participants	18 Participants	5 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 112 · No	13 Participants	14 Participants	9 Participants	13 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 147 EOS · Yes - at least 1 wart reduction from Baseline	13 Participants	8 Participants	19 Participants	5 Participants
Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) F/U Visit Day 147 EOS · No	17 Participants	16 Participants	8 Participants	13 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Complete clearance compared from Day 84 to follow-up days 112 and 147.

Population: ITT Population

Proportion of subjects who are clear at all three study visits, Study Day 84 (End of Treatment) Visit and remain clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study).

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) Yes	5 Participants	0 Participants	7 Participants	0 Participants
Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) No	25 Participants	24 Participants	20 Participants	18 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Study Day 84, Follow-up Visits at Days 112 and 147 (EOS)

Population: ITT Population

Change from baseline in total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 (EOT)	-52.60 mm^2 Standard Deviation 67.067	-23.64 mm^2 Standard Deviation 59.722	-72.87 mm^2 Standard Deviation 91.659	1.60 mm^2 Standard Deviation 33.796
Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Follow-up Day 112	-79.43 mm^2 Standard Deviation 99.679	-20.35 mm^2 Standard Deviation 53.289	-82.79 mm^2 Standard Deviation 71.750	1.40 mm^2 Standard Deviation 39.963
Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Follow-up Visit Day 147 (EOS)	-59.28 mm^2 Standard Deviation 100.988	-6.02 mm^2 Standard Deviation 36.929	-68.78 mm^2 Standard Deviation 68.710	2.21 mm^2 Standard Deviation 45.035

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)

Population: ITT Population

Percent Change from baseline in the total wart area (sum of individual warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).

Outcome measures

Outcome measures
Measure	Part B Pooled With Part A: VP-102 6-hour n=30 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=24 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=27 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 24-hour n=18 Participants Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Study Day 84 (EOT)	-46.0 Change from baseline in % of wart area Standard Deviation 52.77	-22.3 Change from baseline in % of wart area Standard Deviation 57.92	-64.2 Change from baseline in % of wart area Standard Deviation 55.78	-7.3 Change from baseline in % of wart area Standard Deviation 93.42
Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Follow-up Day 112	-48.2 Change from baseline in % of wart area Standard Deviation 54.67	-21.5 Change from baseline in % of wart area Standard Deviation 64.54	-76.4 Change from baseline in % of wart area Standard Deviation 12.33	13.8 Change from baseline in % of wart area Standard Deviation 129.61
Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) Follow-up Day 147 (EOS)	-45.8 Change from baseline in % of wart area Standard Deviation 71.37	-11.7 Change from baseline in % of wart area Standard Deviation 52.52	-69.3 Change from baseline in % of wart area Standard Deviation 16.44	19.9 Change from baseline in % of wart area Standard Deviation 138.49

Adverse Events

Part B Pooled With Part A: Placebo 24-hour

Serious events: 1 serious events

Other events: 9 other events

Deaths: 0 deaths

Part A: VP-102 2-hour

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Part A: Placebo 2-hour

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B Pooled With Part A: VP-102 6-hour

Serious events: 1 serious events

Other events: 29 other events

Deaths: 0 deaths

Part B Pooled With Part A: Placebo 6-hour

Serious events: 1 serious events

Other events: 15 other events

Deaths: 0 deaths

Part B Pooled With Part A VP-102 24-hour

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part B Pooled With Part A: Placebo 24-hour n=20 participants at risk Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part A: VP-102 2-hour n=5 participants at risk Data summarized for VP-102 2-hour group.	Part A: Placebo 2-hour n=1 participants at risk Data summarized for VP-102 2-hour group..	Part B Pooled With Part A: VP-102 6-hour n=29 participants at risk Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=22 participants at risk Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=28 participants at risk Data will be summarized for both Part B pooled with Part A for the applicable treatments.
Infections and infestations Pneumonia	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	3.4% 1/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Psychiatric disorders Bipolar disorder	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.

Other adverse events

Other adverse events
Measure	Part B Pooled With Part A: Placebo 24-hour n=20 participants at risk Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part A: VP-102 2-hour n=5 participants at risk Data summarized for VP-102 2-hour group.	Part A: Placebo 2-hour n=1 participants at risk Data summarized for VP-102 2-hour group..	Part B Pooled With Part A: VP-102 6-hour n=29 participants at risk Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A: Placebo 6-hour n=22 participants at risk Data will be summarized for both Part B pooled with Part A for the applicable treatments.	Part B Pooled With Part A VP-102 24-hour n=28 participants at risk Data will be summarized for both Part B pooled with Part A for the applicable treatments.
General disorders Application site vesicles	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	80.0% 4/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	86.2% 25/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	92.9% 26/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site pain	20.0% 4/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	80.0% 4/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	69.0% 20/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	13.6% 3/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	67.9% 19/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site erythema	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	40.0% 2/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	48.3% 14/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	13.6% 3/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	67.9% 19/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site pruritus	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	48.3% 14/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	22.7% 5/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	35.7% 10/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site scab	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	44.8% 13/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	50.0% 14/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site discolouration	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	80.0% 4/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	24.1% 7/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	18.2% 4/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	21.4% 6/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site dryness	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	24.1% 7/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	9.1% 2/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	21.4% 6/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site erosion	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	80.0% 4/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.7% 6/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	25.0% 7/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site oedema	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	60.0% 3/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	10.3% 3/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	25.0% 7/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
General disorders Application site exfoliation	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	10.3% 3/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	9.1% 2/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	17.9% 5/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Infections and infestations Sinusitis	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	10.3% 3/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Infections and infestations Tooth abscess	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Injury, poisoning and procedural complications Toxicity to various agents	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Psychiatric disorders Anxiety	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Psychiatric disorders Depression	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Psychiatric disorders Insomnia	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Gastrointestinal disorders Nausea	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Musculoskeletal and connective tissue disorders Arthritis	5.0% 1/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Infections and infestations Abscess limb	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Psychiatric disorders Major Depression	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Psychiatric disorders Suicide attempt	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Surgical and medical procedures Umbilical hernia repair	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Nervous system disorders Headache	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Gastrointestinal disorders Vomiting	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Infections and infestations Nasopharyngitis	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	4.5% 1/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Infections and infestations Vulvovaginal mycotic infection	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.
Gastrointestinal disorders Gastritis	0.00% 0/20 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	20.0% 1/5 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/1 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/29 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/22 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.	0.00% 0/28 • Adverse Events (AEs) were collected following the first application of study drug through Study Day 147. TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.

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