Condylomata Acuminata, Papillomavirus Infections, Sexually Transmitted Diseases, Sexually Transmitted Diseases, Viral, Skin Diseases, Skin Diseases, Infectious, Skin Diseases, Viral, Warts
Conditions
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
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.
The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin
Sponsors
Study design
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
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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Arm | Count |
|---|---|
| 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 |
| Total | 105 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 | FG007 |
|---|---|---|---|---|---|---|---|---|---|
| Overall Study | COVID-19 Related | 0 | 0 | 0 | 0 | 2 | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 | 0 | 6 | 4 | 4 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 | 1 | 0 | 2 |
Baseline characteristics
| Characteristic | Part A: VP-102 2-hour | Part A: VP-102 6-hour | Part A: VP-102 24-hour | Part A: Placebo | Part B: VP-102 6-hour | Part B: 6-hour-Placebo | Part B: VP-102 24-hour | Part B: 24-hour-Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | 34.40 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 warts | 7 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 Participants | 0 Participants | 0 Participants | 0 Participants | 6 Participants | 1 Participants | 2 Participants | 5 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 5 Participants | 5 Participants | 3 Participants | 19 Participants | 22 Participants | 20 Participants | 12 Participants | 90 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 0 Participants | 1 Participants | 0 Participants | 6 Participants | 8 Participants | 1 Participants | 6 Participants | 24 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 2 Participants | 0 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 3 Participants | 5 Participants | 3 Participants | 3 Participants | 19 Participants | 12 Participants | 21 Participants | 11 Participants | 77 Participants |
| Region of Enrollment United States | 5 participants | 5 participants | 5 participants | 3 participants | 25 participants | 23 participants | 22 participants | 17 participants | 105 participants |
| Sex: Female, Male Female | 4 Participants | 3 Participants | 2 Participants | 0 Participants | 10 Participants | 10 Participants | 10 Participants | 7 Participants | 46 Participants |
| Sex: Female, Male Male | 1 Participants | 2 Participants | 3 Participants | 3 Participants | 15 Participants | 13 Participants | 12 Participants | 10 Participants | 59 Participants |
Adverse events
| Event type | EG000 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 / 29 | 0 / 22 | 0 / 28 | 0 / 20 | 0 / 5 | 0 / 1 |
| other Total, other adverse events | 29 / 29 | 15 / 22 | 28 / 28 | 9 / 20 | 5 / 5 | 0 / 1 |
| serious Total, serious adverse events | 1 / 29 | 1 / 22 | 0 / 28 | 1 / 20 | 0 / 5 | 0 / 1 |
Outcome results
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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. | Yes | 11 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. | No | 19 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. | No | 23 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. | Yes | 1 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. | Yes | 9 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. | No | 18 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. | Yes | 0 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. | No | 18 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | -4.0 Warts | Standard Deviation 4.95 |
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | -4.4 Warts | Standard Deviation 5.8 |
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | -5.2 Warts | Standard Deviation 4.72 |
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | -6.1 Warts | Standard Deviation 5.24 |
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Day 112 | -5.3 Warts | Standard Deviation 5.21 |
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Visit Day 147 EOS | -5.0 Warts | Standard Deviation 7.63 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Visit Day 147 EOS | -1.2 Warts | Standard Deviation 5.49 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | -1.1 Warts | Standard Deviation 4.92 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | -0.3 Warts | Standard Deviation 1.11 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | -0.9 Warts | Standard Deviation 3.98 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | -1.1 Warts | Standard Deviation 3.69 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Day 112 | -1.1 Warts | Standard Deviation 5.33 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | -6.3 Warts | Standard Deviation 5.45 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | -7.1 Warts | Standard Deviation 5.09 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | -7.4 Warts | Standard Deviation 6.37 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Visit Day 147 EOS | -7.9 Warts | Standard Deviation 5.46 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Day 112 | -8.1 Warts | Standard Deviation 5.54 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | -5.3 Warts | Standard Deviation 4.25 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Day 112 | -0.3 Warts | Standard Deviation 4.39 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Visit Day 147 EOS | -0.1 Warts | Standard Deviation 4.66 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | -0.5 Warts | Standard Deviation 5.01 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | 0.1 Warts | Standard Deviation 5.12 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | 0.6 Warts | Standard Deviation 30.07 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | 0.5 Warts | Standard Deviation 5.17 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | -41.4 Wart percentage change from Baseline | Standard Deviation 32.38 |
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | -49.0 Wart percentage change from Baseline | Standard Deviation 37.18 |
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | -65.8 Wart percentage change from Baseline | Standard Deviation 30.69 |
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 End of Treatment Visit | -79.7 Wart percentage change from Baseline | Standard Deviation 34.27 |
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Day 112 | -68.2 Wart percentage change from Baseline | Standard Deviation 43.2 |
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Visit Day 147 End of Study | -42.5 Wart percentage change from Baseline | Standard Deviation 111.83 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Visit Day 147 End of Study | -6.0 Wart percentage change from Baseline | Standard Deviation 86.56 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 End of Treatment Visit | -1.6 Wart percentage change from Baseline | Standard Deviation 78.34 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | -6.2 Wart percentage change from Baseline | Standard Deviation 13.14 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | -5.1 Wart percentage change from Baseline | Standard Deviation 66.26 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | -8.9 Wart percentage change from Baseline | Standard Deviation 44.46 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Day 112 | 1.9 Wart percentage change from Baseline | Standard Deviation 91.11 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | -69.3 Wart percentage change from Baseline | Standard Deviation 34.03 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | -77.3 Wart percentage change from Baseline | Standard Deviation 26.87 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 End of Treatment Visit | -77.1 Wart percentage change from Baseline | Standard Deviation 38.66 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Visit Day 147 End of Study | -79.6 Wart percentage change from Baseline | Standard Deviation 25.01 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Day 112 | -79.2 Wart percentage change from Baseline | Standard Deviation 28.36 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | -58.5 Wart percentage change from Baseline | Standard Deviation 26.69 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Day 112 | -14.2 Wart percentage change from Baseline | Standard Deviation 49.6 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow up Visit Day 147 End of Study | -12.9 Wart percentage change from Baseline | Standard Deviation 50.49 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | -17.8 Wart percentage change from Baseline | Standard Deviation 49.79 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 End of Treatment Visit | -5.5 Wart percentage change from Baseline | Standard Deviation 47.98 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | -2.6 Wart percentage change from Baseline | Standard Deviation 30.07 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | 0.6 Wart percentage change from Baseline | Standard Deviation 41.94 |
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Incidence of >=75% Clearance: YES | 5 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Incidence of >=75% Clearance: YES | 8 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Incidence of >=75% Clearance: YES | 11 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Incidence of >=75% Clearance: YES | 15 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Incidence of >=75% Clearance: YES | 13 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Incidence of >=75% Clearance: YES | 10 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Incidence of >=75% Clearance: YES | 4 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Incidence of >=75% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Incidence of >=75% Clearance: YES | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Incidence of >=75% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Incidence of >=75% Clearance: YES | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Incidence of >=75% Clearance: YES | 3 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Incidence of >=75% Clearance: YES | 14 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Incidence of >=75% Clearance: YES | 12 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Incidence of >=75% Clearance: YES | 15 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Incidence of >=75% Clearance: YES | 13 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Incidence of >=75% Clearance: YES | 13 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Incidence of >=75% Clearance: YES | 6 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Incidence of >=75% Clearance: YES | 3 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Incidence of >=75% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Incidence of >=75% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Incidence of >=75% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Incidence of >=75% Clearance: YES | 1 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Incidence of >=75% Clearance: YES | 1 Participants |
Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Incidence of >=90% Clearance: YES | 1 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Incidence of >=90% Clearance: YES | 5 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Incidence of >=90% Clearance: YES | 7 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Incidence of >=90% Clearance: YES | 14 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Incidence of >=90% Clearance: YES | 11 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Incidence of >=90% Clearance: YES | 9 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Incidence of >=90% Clearance: YES | 3 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Incidence of >=90% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Incidence of >=90% Clearance: YES | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Incidence of >=90% Clearance: YES | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Incidence of >=90% Clearance: YES | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Incidence of >=90% Clearance: YES | 2 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Incidence of >=90% Clearance: YES | 8 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Incidence of >=90% Clearance: YES | 7 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Incidence of >=90% Clearance: YES | 11 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Incidence of >=90% Clearance: YES | 9 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Incidence of >=90% Clearance: YES | 9 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Incidence of >=90% Clearance: YES | 4 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Incidence of >=90% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Incidence of >=90% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Incidence of >=90% Clearance: YES | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Incidence of >=90% Clearance: YES | 0 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Incidence of >=90% Clearance: YES | 0 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Incidence of >=90% Clearance: YES | 0 Participants |
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Yes, Complete Clearance | 1 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Yes, Complete Clearance | 4 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Yes, Complete Clearance | 6 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Yes, Complete Clearance | 11 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Yes, Complete Clearance | 9 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Yes, Complete Clearance | 6 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Yes, Complete Clearance | 3 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Yes, Complete Clearance | 1 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Yes, Complete Clearance | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Yes, Complete Clearance | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Yes, Complete Clearance | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Yes, Complete Clearance | 2 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Yes, Complete Clearance | 8 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Yes, Complete Clearance | 7 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Yes, Complete Clearance | 9 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Yes, Complete Clearance | 8 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Yes, Complete Clearance | 8 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Yes, Complete Clearance | 4 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112: Yes, Complete Clearance | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147: Yes, Complete Clearance | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3: Yes, Complete Clearance | 2 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT: Yes, Complete Clearance | 0 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2: Yes, Complete Clearance | 0 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4: Yes, Complete Clearance | 0 Participants |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 (EOT) | -52.60 mm^2 | Standard Deviation 67.067 |
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Visit Day 147 (EOS) | -59.28 mm^2 | Standard Deviation 100.988 |
| Part B Pooled With Part A: VP-102 6-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 112 | -79.43 mm^2 | Standard Deviation 99.679 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 (EOT) | -23.64 mm^2 | Standard Deviation 59.722 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Visit Day 147 (EOS) | -6.02 mm^2 | Standard Deviation 36.929 |
| Part B Pooled With Part A: Placebo 6-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 112 | -20.35 mm^2 | Standard Deviation 53.289 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 112 | -82.79 mm^2 | Standard Deviation 71.75 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 (EOT) | -72.87 mm^2 | Standard Deviation 91.659 |
| Part B Pooled With Part A VP-102 24-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Visit Day 147 (EOS) | -68.78 mm^2 | Standard Deviation 68.71 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 (EOT) | 1.60 mm^2 | Standard Deviation 33.796 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Visit Day 147 (EOS) | 2.21 mm^2 | Standard Deviation 45.035 |
| Part B Pooled With Part A: Placebo 24-hour | Change From Baseline in Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 112 | 1.40 mm^2 | Standard Deviation 39.963 |
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 (EOT) | -46.0 Change from baseline in % of wart area | Standard Deviation 52.77 |
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 147 (EOS) | -45.8 Change from baseline in % of wart area | Standard Deviation 71.37 |
| Part B Pooled With Part A: VP-102 6-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 112 | -48.2 Change from baseline in % of wart area | Standard Deviation 54.67 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 (EOT) | -22.3 Change from baseline in % of wart area | Standard Deviation 57.92 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 147 (EOS) | -11.7 Change from baseline in % of wart area | Standard Deviation 52.52 |
| Part B Pooled With Part A: Placebo 6-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 112 | -21.5 Change from baseline in % of wart area | Standard Deviation 64.54 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 112 | -76.4 Change from baseline in % of wart area | Standard Deviation 12.33 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 (EOT) | -64.2 Change from baseline in % of wart area | Standard Deviation 55.78 |
| Part B Pooled With Part A VP-102 24-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 147 (EOS) | -69.3 Change from baseline in % of wart area | Standard Deviation 16.44 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 (EOT) | -7.3 Change from baseline in % of wart area | Standard Deviation 93.42 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 147 (EOS) | 19.9 Change from baseline in % of wart area | Standard Deviation 138.49 |
| Part B Pooled With Part A: Placebo 24-hour | Percent Change From Baseline in the Total Wart Area (Sum of Individual Warts) at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Follow-up Day 112 | 13.8 Change from baseline in % of wart area | Standard Deviation 129.61 |
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
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | No | 8 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | No | 10 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112 | No | 13 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | No | 7 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | Yes - at least 1 wart reduction from Baseline | 23 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112 | Yes - at least 1 wart reduction from Baseline | 17 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | Yes - at least 1 wart reduction from Baseline | 22 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | Yes - at least 1 wart reduction from Baseline | 20 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147 EOS | No | 17 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147 EOS | Yes - at least 1 wart reduction from Baseline | 13 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | No | 11 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | Yes - at least 1 wart reduction from Baseline | 19 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | Yes - at least 1 wart reduction from Baseline | 6 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112 | No | 14 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147 EOS | Yes - at least 1 wart reduction from Baseline | 8 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | Yes - at least 1 wart reduction from Baseline | 10 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147 EOS | No | 16 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | No | 14 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | Yes - at least 1 wart reduction from Baseline | 10 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | No | 14 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | Yes - at least 1 wart reduction from Baseline | 9 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | No | 18 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | No | 15 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112 | Yes - at least 1 wart reduction from Baseline | 10 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | Yes - at least 1 wart reduction from Baseline | 21 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147 EOS | Yes - at least 1 wart reduction from Baseline | 19 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | Yes - at least 1 wart reduction from Baseline | 18 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112 | No | 9 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147 EOS | No | 8 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112 | Yes - at least 1 wart reduction from Baseline | 18 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | No | 9 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | Yes - at least 1 wart reduction from Baseline | 17 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | No | 6 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | No | 4 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | No | 10 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | Yes - at least 1 wart reduction from Baseline | 23 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147 EOS | No | 13 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | Yes - at least 1 wart reduction from Baseline | 6 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 2 | No | 12 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | Yes - at least 1 wart reduction from Baseline | 7 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | Yes - at least 1 wart reduction from Baseline | 4 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 4 | No | 14 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | Yes - at least 1 wart reduction from Baseline | 4 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Study Day 84 EOT Visit | No | 14 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112 | Yes - at least 1 wart reduction from Baseline | 5 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 112 | No | 13 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | F/U Visit Day 147 EOS | Yes - at least 1 wart reduction from Baseline | 5 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Exhibiting Reduction of ≥ 1 Treatable Wart From Baseline at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS) | Treatment Visit 3 | No | 11 Participants |
Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study)
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) | Yes | 5 Participants |
| Part B Pooled With Part A: VP-102 6-hour | Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) | No | 25 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) | Yes | 0 Participants |
| Part B Pooled With Part A: Placebo 6-hour | Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) | No | 24 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) | Yes | 7 Participants |
| Part B Pooled With Part A VP-102 24-hour | Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) | No | 20 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) | No | 18 Participants |
| Part B Pooled With Part A: Placebo 24-hour | Proportion of Subjects Who Are Clear at the Study Day 84 (End of Treatment) Visit and Remain Clear at the Follow-up Visits on Study Day 112 and Study Day 147 (End of Study) | Yes | 0 Participants |