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

A Phase 2, Double-Blind, Placebo-Controlled Study to Determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects With External Genital Warts

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03981822
Acronym
CARE-1
Enrollment
105
Registered
2019-06-11
Start date
2019-06-25
Completion date
2020-07-08
Last updated
2024-11-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condylomata Acuminata, Papillomavirus Infections, Sexually Transmitted Diseases, Sexually Transmitted Diseases, Viral, Skin Diseases, Skin Diseases, Infectious, Skin Diseases, Viral, Warts

Keywords

Human Papilloma Virus (HPV), Genital Warts, Sexually Transmitted Disease (STD), Viral Disease

Brief summary

This is a Phase 2, double-blind, placebo-controlled study to determine the dose regimen, safety, tolerability, and efficacy of VP-102 in subjects with External Genital Warts (EGW). This study is divided into two parts (Part A and Part B). Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups prior to progressing to enrollment in Part B. Part A & B will enroll a approximately 108 subjects completing 4 treatment applications every 21 days and continuing with follow-up assessments at Day 84, 112 and 147.

Detailed description

This study is to determine the Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts. It is divided into two parts (Part A and Part B). The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B.In Part A, Study drug (VP-102 or placebo) will be administered once every 21 days for up to four applications. Enrollment will begin in Group 1, then proceed into Group 2, and lastly into Group 3. A safety review will be conducted to determine whether enrollment can be initiated into the next Group. An additional blinded safety review will be performed after all six subjects in Group 3 have completed the 48-hour Visit, in order to support dose selection for Part B (Safety and Efficacy). Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens from Part A. The study will remain blinded until completion of both parts of the study. In Part A, up to 18 subjects will be randomized to VP-102 or placebo treatment with three different regimens. When Part B is open an additional \ 90 subjects will be enrolled and randomized to VP-102 or placebo with two treatment regimens. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2. As an example, if the regimens selected from Part A are the 2-hour and 6-hour applications of VP-102, then VP-102 Regimen 1 would be VP-102 treatment for 2-hours and VP-102 Regimen 2 would be VP-102 treatment for 6-hours. Likewise, Placebo Regimen 1 would be placebo treatment for 2 hours and Placebo Regimen 2 would be placebo treatment for 6-hours. Randomization of the four treatment arms (VP-102 Regimen 1:VP-102 Regimen 2:Placebo Regimen 1:Placebo Regimen 2) will be 3:3:2:2. In both Regimen 1 and Regimen 2, study drug will be administered to EGW once every 21 days for up to four applications. Subjects will be asked to remove the study drug at the designated time selected from the dose regimen findings in Part A of the study. Treatment will continue with a minimum of every 21 days, until complete clearance or a maximum of four treatment sessions. Safety assessments including recording of local skin reactions are conducted at each treatment visit and at follow up visits Day 84, 112, and 147.

Interventions

COMBINATION_PRODUCTVP-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.

COMBINATION_PRODUCTPlacebo

The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin

Sponsors

Instat Consulting, Inc.
CollaboratorOTHER
Paidion Research, Inc.
CollaboratorINDUSTRY
BioClinica, Inc.
CollaboratorINDUSTRY
Verrica Pharmaceuticals Inc.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind

Intervention model description

The aim of Part A is to determine the two best treatment regimens for evaluation of safety and efficacy in Part B. Increasing durations of skin exposure to study drug (VP-102 or placebo) will be evaluated in three treatment groups (n=6/group) that will enroll progressively. Part B of the study will begin enrollment only after the Sponsor has selected the two dose regimens in Part A, which will be called VP-102 Regimen 1 and Regimen 2.Approximately 90 subjects will be enrolled and randomized to one of four treatment arms (two treatment regimens, each with VP-102 and Placebo). Randomization will be stratified by sex so that neither gender exceeds \ 60% of any treatment arm. Two of the treatment arms will be VP-102 Regimen 1 and VP-102 Regimen 2. The other two treatment arms will be placebo (Placebo Regimen 1 and Placebo Regimen 2), with corresponding durations of skin exposure matching those selected for VP-102 Regimen 1 and Regimen 2.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Key Inclusion Criteria: * Be healthy, immunocompetent males or females ≥ 18 years of age * Present with ≥ 2 and ≤ 30 external genital and/or perianal warts in ≥ 1 of the following anatomic areas: * In both sexes: medial thigh (except inguinal fold); supra-pubic, perineal, and perianal areas * In men: over the glans penis (excluding urethral meatus), penis shaft, scrotum, and foreskin * In women: vulva (excluding labia minora and mucosal surfaces) * Have warts present for ≥ 4 weeks at the baseline visit * Have warts that are ≤ 8 mm in diameter each Key

Exclusion criteria

* Have a wart within the allowed treatment area \> 8 mm in diameter or with an eroded or ulcerated surface, in the Investigator's opinion * Have an unclear diagnosis of condyloma * Have any wart types other than genital warts (e.g., common or plantar warts) that require treatment during the study period * Have active genital herpes eruption, or had active genital herpes lesions within 4 weeks before enrollment * Have a history of neoplasia or other HPV-associated malignancies within the last 5 years * Are systemically immunosuppressed * Are sexually active or may become sexually active and are unwilling to practice responsible birth control methods * Are pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.Compares baseline wart count to Day 84, end of treatment.Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.

Secondary

MeasureTime frameDescription
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)Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.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).
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)Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.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).
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)Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.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).
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)Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.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.
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)Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.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).

Other

MeasureTime frameDescription
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)Baseline to Study Day 84, Follow-up Visits at Days 112 and 147 (EOS)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).
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)Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)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).
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)Complete clearance compared from Day 84 to follow-up days 112 and 147.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).
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)Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.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).

Countries

United States

Participant flow

Recruitment details

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

Pre-assignment details

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.

Participants by arm

ArmCount
Part A: VP-102 2-hour
VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments.
5
Part A: VP-102 6-hour
VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.
5
Part A: VP-102 24-hour
VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.
5
Part A: Placebo
Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments.
3
Part B: VP-102 6-hour
VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.
25
Part B: 6-hour-Placebo
Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.
23
Part B: VP-102 24-hour
VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.
22
Part B: 24-hour-Placebo
Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.
17
Total105

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003FG004FG005FG006FG007
Overall StudyCOVID-19 Related00002121
Overall StudyLost to Follow-up01106442
Overall StudyWithdrawal by Subject01000102

Baseline characteristics

CharacteristicPart A: VP-102 2-hourPart A: VP-102 6-hourPart A: VP-102 24-hourPart A: PlaceboPart B: VP-102 6-hourPart B: 6-hour-PlaceboPart B: VP-102 24-hourPart B: 24-hour-PlaceboTotal
Age, Continuous34.40 years
STANDARD_DEVIATION 9.915
43.00 years
STANDARD_DEVIATION 8.246
33.80 years
STANDARD_DEVIATION 5.263
32.00 years
STANDARD_DEVIATION 3.606
38.12 years
STANDARD_DEVIATION 10.138
35.87 years
STANDARD_DEVIATION 7.973
34.45 years
STANDARD_DEVIATION 7.526
33.88 years
STANDARD_DEVIATION 6.47
35.85 years
STANDARD_DEVIATION 8.26
Baseline number of treatable external genital warts7 genital warts
STANDARD_DEVIATION 5.568
9.60 genital warts
STANDARD_DEVIATION 12.012
13.00 genital warts
STANDARD_DEVIATION 8.276
11.67 genital warts
STANDARD_DEVIATION 12.423
8.28 genital warts
STANDARD_DEVIATION 6.38
5.87 genital warts
STANDARD_DEVIATION 3.684
8.68 genital warts
STANDARD_DEVIATION 5.489
7.76 genital warts
STANDARD_DEVIATION 6.897
8.08 genital warts
STANDARD_DEVIATION 6.395
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants0 Participants0 Participants0 Participants6 Participants1 Participants2 Participants5 Participants15 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
4 Participants5 Participants5 Participants3 Participants19 Participants22 Participants20 Participants12 Participants90 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
2 Participants0 Participants1 Participants0 Participants6 Participants8 Participants1 Participants6 Participants24 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants1 Participants0 Participants0 Participants2 Participants0 Participants0 Participants3 Participants
Race (NIH/OMB)
White
3 Participants5 Participants3 Participants3 Participants19 Participants12 Participants21 Participants11 Participants77 Participants
Region of Enrollment
United States
5 participants5 participants5 participants3 participants25 participants23 participants22 participants17 participants105 participants
Sex: Female, Male
Female
4 Participants3 Participants2 Participants0 Participants10 Participants10 Participants10 Participants7 Participants46 Participants
Sex: Female, Male
Male
1 Participants2 Participants3 Participants3 Participants15 Participants13 Participants12 Participants10 Participants59 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
EG004
affected / at risk
EG005
affected / at risk
deaths
Total, all-cause mortality
0 / 290 / 220 / 280 / 200 / 50 / 1
other
Total, other adverse events
29 / 2915 / 2228 / 289 / 205 / 50 / 1
serious
Total, serious adverse events
1 / 291 / 220 / 281 / 200 / 50 / 1

Outcome results

Primary

Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.

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

Time frame: 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.

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Part B Pooled With Part A: VP-102 6-hourProportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.Yes11 Participants
Part B Pooled With Part A: VP-102 6-hourProportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.No19 Participants
Part B Pooled With Part A: Placebo 6-hourProportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.No23 Participants
Part B Pooled With Part A: Placebo 6-hourProportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.Yes1 Participants
Part B Pooled With Part A VP-102 24-hourProportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.Yes9 Participants
Part B Pooled With Part A VP-102 24-hourProportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.No18 Participants
Part B Pooled With Part A: Placebo 24-hourProportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.Yes0 Participants
Part B Pooled With Part A: Placebo 24-hourProportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.No18 Participants
Comparison: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0048Cochran-Mantel-Haenszel
Comparison: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0075Cochran-Mantel-Haenszel
Secondary

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)

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.

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Part B Pooled With Part A: VP-102 6-hourChange 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 WartsStandard Deviation 4.95
Part B Pooled With Part A: VP-102 6-hourChange 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 WartsStandard Deviation 5.8
Part B Pooled With Part A: VP-102 6-hourChange 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 WartsStandard Deviation 4.72
Part B Pooled With Part A: VP-102 6-hourChange 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 WartsStandard Deviation 5.24
Part B Pooled With Part A: VP-102 6-hourChange 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 WartsStandard Deviation 5.21
Part B Pooled With Part A: VP-102 6-hourChange 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 WartsStandard Deviation 7.63
Part B Pooled With Part A: Placebo 6-hourChange 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-1.2 WartsStandard Deviation 5.49
Part B Pooled With Part A: Placebo 6-hourChange 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-1.1 WartsStandard Deviation 4.92
Part B Pooled With Part A: Placebo 6-hourChange 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 2-0.3 WartsStandard Deviation 1.11
Part B Pooled With Part A: Placebo 6-hourChange 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 4-0.9 WartsStandard Deviation 3.98
Part B Pooled With Part A: Placebo 6-hourChange 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 3-1.1 WartsStandard Deviation 3.69
Part B Pooled With Part A: Placebo 6-hourChange 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 112-1.1 WartsStandard Deviation 5.33
Part B Pooled With Part A VP-102 24-hourChange 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 3-6.3 WartsStandard Deviation 5.45
Part B Pooled With Part A VP-102 24-hourChange 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 4-7.1 WartsStandard Deviation 5.09
Part B Pooled With Part A VP-102 24-hourChange 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-7.4 WartsStandard Deviation 6.37
Part B Pooled With Part A VP-102 24-hourChange 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-7.9 WartsStandard Deviation 5.46
Part B Pooled With Part A VP-102 24-hourChange 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 112-8.1 WartsStandard Deviation 5.54
Part B Pooled With Part A VP-102 24-hourChange 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 2-5.3 WartsStandard Deviation 4.25
Part B Pooled With Part A: Placebo 24-hourChange 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 112-0.3 WartsStandard Deviation 4.39
Part B Pooled With Part A: Placebo 24-hourChange 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-0.1 WartsStandard Deviation 4.66
Part B Pooled With Part A: Placebo 24-hourChange 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 3-0.5 WartsStandard Deviation 5.01
Part B Pooled With Part A: Placebo 24-hourChange 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 Visit0.1 WartsStandard Deviation 5.12
Part B Pooled With Part A: Placebo 24-hourChange 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 20.6 WartsStandard Deviation 30.07
Part B Pooled With Part A: Placebo 24-hourChange 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 40.5 WartsStandard Deviation 5.17
Comparison: Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: 0.002195% CI: [-5.41, -1.24]Mixed Models Analysis
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: 0.01595% CI: [-5.95, -0.66]Mixed Models Analysis
Comparison: Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.p-value: 0.001195% CI: [-6.54, -1.69]Mixed Models Analysis
Comparison: Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.p-value: 0.000795% CI: [-8.25, -2.32]Mixed Models Analysis
Comparison: Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.001295% CI: [-7.5, -1.91]Mixed Models Analysis
Comparison: Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.p-value: 0.034995% CI: [-6.78, -0.26]Mixed Models Analysis
Comparison: Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-7.47, -2.85]Mixed Models Analysis
Comparison: Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.p-value: 0.000595% CI: [-8.37, -2.43]Mixed Models Analysis
Comparison: Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-9.65, -4.12]Mixed Models Analysis
Comparison: Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.p-value: 0.000495% CI: [-9.67, -2.92]Mixed Models Analysis
Comparison: Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-9.89, -3.57]Mixed Models Analysis
Comparison: Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.p-value: 0.000595% CI: [-10.2, -2.94]Mixed Models Analysis
Secondary

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)

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).

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Part B Pooled With Part A: VP-102 6-hourPercent 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 BaselineStandard Deviation 32.38
Part B Pooled With Part A: VP-102 6-hourPercent 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 BaselineStandard Deviation 37.18
Part B Pooled With Part A: VP-102 6-hourPercent 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 BaselineStandard Deviation 30.69
Part B Pooled With Part A: VP-102 6-hourPercent 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 BaselineStandard Deviation 34.27
Part B Pooled With Part A: VP-102 6-hourPercent 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 BaselineStandard Deviation 43.2
Part B Pooled With Part A: VP-102 6-hourPercent 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 BaselineStandard Deviation 111.83
Part B Pooled With Part A: Placebo 6-hourPercent 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-6.0 Wart percentage change from BaselineStandard Deviation 86.56
Part B Pooled With Part A: Placebo 6-hourPercent 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-1.6 Wart percentage change from BaselineStandard Deviation 78.34
Part B Pooled With Part A: Placebo 6-hourPercent 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 2-6.2 Wart percentage change from BaselineStandard Deviation 13.14
Part B Pooled With Part A: Placebo 6-hourPercent 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 4-5.1 Wart percentage change from BaselineStandard Deviation 66.26
Part B Pooled With Part A: Placebo 6-hourPercent 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 3-8.9 Wart percentage change from BaselineStandard Deviation 44.46
Part B Pooled With Part A: Placebo 6-hourPercent 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 1121.9 Wart percentage change from BaselineStandard Deviation 91.11
Part B Pooled With Part A VP-102 24-hourPercent 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 3-69.3 Wart percentage change from BaselineStandard Deviation 34.03
Part B Pooled With Part A VP-102 24-hourPercent 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 4-77.3 Wart percentage change from BaselineStandard Deviation 26.87
Part B Pooled With Part A VP-102 24-hourPercent 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-77.1 Wart percentage change from BaselineStandard Deviation 38.66
Part B Pooled With Part A VP-102 24-hourPercent 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-79.6 Wart percentage change from BaselineStandard Deviation 25.01
Part B Pooled With Part A VP-102 24-hourPercent 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 112-79.2 Wart percentage change from BaselineStandard Deviation 28.36
Part B Pooled With Part A VP-102 24-hourPercent 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 2-58.5 Wart percentage change from BaselineStandard Deviation 26.69
Part B Pooled With Part A: Placebo 24-hourPercent 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 112-14.2 Wart percentage change from BaselineStandard Deviation 49.6
Part B Pooled With Part A: Placebo 24-hourPercent 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-12.9 Wart percentage change from BaselineStandard Deviation 50.49
Part B Pooled With Part A: Placebo 24-hourPercent 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 3-17.8 Wart percentage change from BaselineStandard Deviation 49.79
Part B Pooled With Part A: Placebo 24-hourPercent 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-5.5 Wart percentage change from BaselineStandard Deviation 47.98
Part B Pooled With Part A: Placebo 24-hourPercent 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 2-2.6 Wart percentage change from BaselineStandard Deviation 30.07
Part B Pooled With Part A: Placebo 24-hourPercent 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 40.6 Wart percentage change from BaselineStandard Deviation 41.94
Comparison: Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-51.31, -20.87]Mixed Models Analysis
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: 0.000495% CI: [-66.18, -19.56]Mixed Models Analysis
Comparison: Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-88.15, -35.87]Mixed Models Analysis
Comparison: Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-111.44, -49.77]Mixed Models Analysis
Comparison: Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.000195% CI: [-103.17, -35.25]Mixed Models Analysis
Comparison: Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.p-value: 0.103395% CI: [-90.61, 8.56]Mixed Models Analysis
Comparison: Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-73.26, -39.39]Mixed Models Analysis
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-81.61, -28.8]Mixed Models Analysis
Comparison: Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.p-value: <0.000195% CI: [-107.19, -45.61]Mixed Models Analysis
Comparison: Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.p-value: 0.000395% CI: [-102.96, -31.55]Mixed Models Analysis
Comparison: Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.000495% CI: [-110.32, -32.78]Mixed Models Analysis
Comparison: Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.p-value: 0.017895% CI: [-120.82, -11.88]Mixed Models Analysis
Secondary

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)

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).

Time frame: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES5 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES8 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES11 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES15 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES13 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES10 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES4 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES3 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES14 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES12 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES15 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES13 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES13 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES6 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES3 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES1 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES1 Participants
Comparison: Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0356Cochran-Mantel-Haenszel
Comparison: Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: 0.1477Cochran-Mantel-Haenszel
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0062Cochran-Mantel-Haenszel
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0046Cochran-Mantel-Haenszel
Comparison: Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0177Cochran-Mantel-Haenszel
Comparison: Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0054Cochran-Mantel-Haenszel
Comparison: Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0013Cochran-Mantel-Haenszel
Comparison: Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0034Cochran-Mantel-Haenszel
Comparison: Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0156Cochran-Mantel-Haenszel
Comparison: Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0367Cochran-Mantel-Haenszel
Comparison: Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.p-value: 0.1746Cochran-Mantel-Haenszel
Comparison: Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.p-value: 0.0123Cochran-Mantel-Haenszel
Secondary

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)

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).

Time frame: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES1 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES5 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES7 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES14 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES11 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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: YES9 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES3 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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: YES2 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES8 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES7 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES11 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES9 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES9 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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: YES4 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES0 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES0 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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: YES0 Participants
Comparison: Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.p-value: 0.3642Cochran-Mantel-Haenszel
Comparison: Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.p-value: 0.0356Cochran-Mantel-Haenszel
Comparison: Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.p-value: 0.0118Cochran-Mantel-Haenszel
Comparison: Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.p-value: 0.0026Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.p-value: 0.0174Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.p-value: 0.1311Cochran-Mantel-Haenszel
Comparison: Treatment Visit 2 Part B summary is pooled with its respective treatments from Part A.p-value: 0.0967Cochran-Mantel-Haenszel
Comparison: Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.p-value: 0.1357Cochran-Mantel-Haenszel
Comparison: Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.p-value: 0.0184Cochran-Mantel-Haenszel
Comparison: Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.p-value: 0.0024Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.p-value: 0.1034Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.p-value: 0.1029Cochran-Mantel-Haenszel
Secondary

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)

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).

Time frame: 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

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Part B Pooled With Part A: VP-102 6-hourProportion 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 Clearance1 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 Clearance4 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 Clearance6 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 Clearance11 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 Clearance9 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 Clearance6 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 Clearance3 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 Clearance1 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 Clearance0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 Clearance0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 Clearance0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 Clearance2 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 Clearance8 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 Clearance7 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 Clearance9 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 Clearance8 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 Clearance8 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 Clearance4 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 Clearance2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 Clearance2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 Clearance2 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 Clearance0 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 Clearance0 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 Clearance0 Participants
Comparison: Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.p-value: 0.3642Cochran-Mantel-Haenszel
Comparison: Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0967Cochran-Mantel-Haenszel
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0648Cochran-Mantel-Haenszel
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: 0.1357Cochran-Mantel-Haenszel
Comparison: Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.p-value: 0.019Cochran-Mantel-Haenszel
Comparison: Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.p-value: 0.0184Cochran-Mantel-Haenszel
Comparison: Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.p-value: 0.0048Cochran-Mantel-Haenszel
Comparison: Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.p-value: 0.0075Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.p-value: 0.0539Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.p-value: 0.1638Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.p-value: 0.4766Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.p-value: 0.1588Cochran-Mantel-Haenszel
Other Pre-specified

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)

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).

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

Population: ITT Population

ArmMeasureGroupValue (MEAN)Dispersion
Part B Pooled With Part A: VP-102 6-hourChange 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^2Standard Deviation 67.067
Part B Pooled With Part A: VP-102 6-hourChange 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^2Standard Deviation 100.988
Part B Pooled With Part A: VP-102 6-hourChange 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^2Standard Deviation 99.679
Part B Pooled With Part A: Placebo 6-hourChange 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)-23.64 mm^2Standard Deviation 59.722
Part B Pooled With Part A: Placebo 6-hourChange 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)-6.02 mm^2Standard Deviation 36.929
Part B Pooled With Part A: Placebo 6-hourChange 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 112-20.35 mm^2Standard Deviation 53.289
Part B Pooled With Part A VP-102 24-hourChange 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 112-82.79 mm^2Standard Deviation 71.75
Part B Pooled With Part A VP-102 24-hourChange 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)-72.87 mm^2Standard Deviation 91.659
Part B Pooled With Part A VP-102 24-hourChange 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)-68.78 mm^2Standard Deviation 68.71
Part B Pooled With Part A: Placebo 24-hourChange 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)1.60 mm^2Standard Deviation 33.796
Part B Pooled With Part A: Placebo 24-hourChange 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)2.21 mm^2Standard Deviation 45.035
Part B Pooled With Part A: Placebo 24-hourChange 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 1121.40 mm^2Standard Deviation 39.963
Comparison: Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.p-value: 0.122295% CI: [-76.1, 9.23]Mixed Models Analysis
Comparison: Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.p-value: 0.040395% CI: [-81.3, -1.9]Mixed Models Analysis
Comparison: Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.p-value: 0.086395% CI: [-77.79, 5.33]Mixed Models Analysis
Comparison: Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.p-value: 0.042895% CI: [-100.76, -1.73]Mixed Models Analysis
Comparison: Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.008495% CI: [-110.46, -17]Mixed Models Analysis
Comparison: Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.p-value: 0.027395% CI: [-103.08, -6.35]Mixed Models Analysis
Other Pre-specified

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)

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).

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

Population: ITT Population

ArmMeasureGroupValue (MEAN)Dispersion
Part B Pooled With Part A: VP-102 6-hourPercent 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 areaStandard Deviation 52.77
Part B Pooled With Part A: VP-102 6-hourPercent 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 areaStandard Deviation 71.37
Part B Pooled With Part A: VP-102 6-hourPercent 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 areaStandard Deviation 54.67
Part B Pooled With Part A: Placebo 6-hourPercent 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)-22.3 Change from baseline in % of wart areaStandard Deviation 57.92
Part B Pooled With Part A: Placebo 6-hourPercent 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)-11.7 Change from baseline in % of wart areaStandard Deviation 52.52
Part B Pooled With Part A: Placebo 6-hourPercent 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 112-21.5 Change from baseline in % of wart areaStandard Deviation 64.54
Part B Pooled With Part A VP-102 24-hourPercent 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 112-76.4 Change from baseline in % of wart areaStandard Deviation 12.33
Part B Pooled With Part A VP-102 24-hourPercent 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)-64.2 Change from baseline in % of wart areaStandard Deviation 55.78
Part B Pooled With Part A VP-102 24-hourPercent 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)-69.3 Change from baseline in % of wart areaStandard Deviation 16.44
Part B Pooled With Part A: Placebo 24-hourPercent 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)-7.3 Change from baseline in % of wart areaStandard Deviation 93.42
Part B Pooled With Part A: Placebo 24-hourPercent 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)19.9 Change from baseline in % of wart areaStandard Deviation 138.49
Part B Pooled With Part A: Placebo 24-hourPercent 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 11213.8 Change from baseline in % of wart areaStandard Deviation 129.61
Comparison: Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.p-value: 0.308395% CI: [-69.96, 22.47]Mixed Models Analysis
Comparison: Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.168695% CI: [-86.93, 15.56]Mixed Models Analysis
Comparison: Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.p-value: 0.238495% CI: [-87.04, 22.1]Mixed Models Analysis
Comparison: Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.p-value: 0.060395% CI: [-103.37, 2.27]Mixed Models Analysis
Comparison: Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.010995% CI: [-138.71, -18.83]Mixed Models Analysis
Comparison: Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.p-value: 0.046795% CI: [-127.64, -0.99]Mixed Models Analysis
Other Pre-specified

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)

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).

Time frame: 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

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Part B Pooled With Part A: VP-102 6-hourProportion 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 2No8 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 3No10 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 112No13 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 4No7 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 4Yes - at least 1 wart reduction from Baseline23 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 112Yes - at least 1 wart reduction from Baseline17 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 2Yes - at least 1 wart reduction from Baseline22 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 3Yes - at least 1 wart reduction from Baseline20 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 EOSNo17 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 EOSYes - at least 1 wart reduction from Baseline13 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 VisitNo11 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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 VisitYes - at least 1 wart reduction from Baseline19 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 2Yes - at least 1 wart reduction from Baseline6 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 112No14 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 EOSYes - at least 1 wart reduction from Baseline8 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 3Yes - at least 1 wart reduction from Baseline10 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 EOSNo16 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 3No14 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 4Yes - at least 1 wart reduction from Baseline10 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 4No14 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 VisitYes - at least 1 wart reduction from Baseline9 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 2No18 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 VisitNo15 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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 112Yes - at least 1 wart reduction from Baseline10 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 3Yes - at least 1 wart reduction from Baseline21 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 EOSYes - at least 1 wart reduction from Baseline19 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 VisitYes - at least 1 wart reduction from Baseline18 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 112No9 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 EOSNo8 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 112Yes - at least 1 wart reduction from Baseline18 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 VisitNo9 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 4Yes - at least 1 wart reduction from Baseline17 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 3No6 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 2No4 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 4No10 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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 2Yes - at least 1 wart reduction from Baseline23 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 EOSNo13 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 2Yes - at least 1 wart reduction from Baseline6 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 2No12 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 3Yes - at least 1 wart reduction from Baseline7 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 4Yes - at least 1 wart reduction from Baseline4 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 4No14 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 VisitYes - at least 1 wart reduction from Baseline4 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 VisitNo14 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 112Yes - at least 1 wart reduction from Baseline5 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 112No13 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 EOSYes - at least 1 wart reduction from Baseline5 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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 3No11 Participants
Comparison: Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0004Cochran-Mantel-Haenszel
Comparison: Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0005Cochran-Mantel-Haenszel
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0698Cochran-Mantel-Haenszel
Comparison: Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.p-value: 0.01Cochran-Mantel-Haenszel
Comparison: Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0101Cochran-Mantel-Haenszel
Comparison: Treatment Visit 4: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0077Cochran-Mantel-Haenszel
Comparison: Study Day 84 EOT Visit: Part B summary is pooled with its respective treatments from Part A.p-value: 0.064Cochran-Mantel-Haenszel
Comparison: Study Day 84 EOT: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0045Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.284Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0132Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.p-value: 0.4668Cochran-Mantel-Haenszel
Comparison: Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0064Cochran-Mantel-Haenszel
Other Pre-specified

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)

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).

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

Population: ITT Population

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Part B Pooled With Part A: VP-102 6-hourProportion 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)Yes5 Participants
Part B Pooled With Part A: VP-102 6-hourProportion 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)No25 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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)Yes0 Participants
Part B Pooled With Part A: Placebo 6-hourProportion 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)No24 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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)Yes7 Participants
Part B Pooled With Part A VP-102 24-hourProportion 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)No20 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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)No18 Participants
Part B Pooled With Part A: Placebo 24-hourProportion 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)Yes0 Participants
Comparison: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0364Mantel Haenszel
Comparison: Part B summary is pooled with its respective treatments from Part A.p-value: 0.0215Cochran-Mantel-Haenszel

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026