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Warts

Skin Diseases, Infectious

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Skin Diseases, Viral

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Neoplasms, Glandular and Epithelial

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Sexually Transmitted Diseases, Viral

Genital Diseases

Urogenital Diseases

Disease Attributes

Any male health plan member who receives at least one dose of GARDASIL™

Regimen Initiators who complete the 3-dose vaccination regimen within 12 months

Regimen Initiators who were members of the health plan during the 12-month period prior to their first dose of GARDASIL™

This is a post-licensure safety observation cohort study to describe the general safety of GARDASIL™ (a quadrivalent human papillomavirus vaccine) in males.

Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)

Post-Licensure Observational Study of the Safety of GARDASIL™ in Males

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Merck Sharp & Dohme LLC

Condylomata Acuminata

Pharmaceutical Solutions

All Drugs and Chemicals

Cantharidin

Enzyme Inhibitors

For part A, VP-102 will be applied for 2 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 2 hours and removed.In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 6 hours and removed. If selected as a dose regimen for Part B VP-102 will be applied for 6 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 24 hours and removed. If selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. In both parts, VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 2-,6- or 24- hours and removed. Placebo is applied every 21 days for 4 treatments.

Part B, VP-102 will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B, Placebo will be applied for 6 hours and removed. VP-102 is applied every 21 days for 4 treatments.

For part A, VP-102 will be applied for 24 hours and removed. If 24 hours is selected as a dose regimen for Part B, VP-102 will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B, VP-Placebo will be applied for 24 hours and removed. VP-102 is applied every 21 days for 4 treatments.

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.

VP-102 and applicator

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

Placebo

Scott Guenthner, MD

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.

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.

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.

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

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 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).

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).

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

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 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 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).

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).

Instat Consulting, Inc.

Paidion Research, Inc.

BioClinica, Inc.

Verrica Pharmaceuticals Inc.

TEAEs defined as those AEs that occurred after dosing and those existing AEs that worsened during the study. Subject numbers in the AE summaries differ from the participant flow module based on the differences in the ITT population and the safety population. Due to randomization system errors, one subject was randomized to VP-102 6-hour but received VP-102 24-hour. Two subjects were randomized to Placebo 6-hour but received Placebo 24-hour.

Data will be summarized for both Part B pooled with Part A for the applicable treatments.

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

Part B Pooled With Part A: Placebo 6-hour

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

Part B Pooled With Part A: Placebo 24-hour

Part A: VP-102 2-hour

Data summarized for VP-102 2-hour group..

Part A: Placebo 2-hour

VP-102 will be applied for 2-hours and removed. VP-102 is applied every 21 days for 4 treatments.

VP-102 will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part A: VP-102 6-hour

VP-102 will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part A: VP-102 24-hour

Placebo will be applied for 2-,6- or 12-hours and removed. Placebo is applied every 21 days for 4 treatments.

Part A: Placebo

Part B: VP-102 6-hour

Placebo will be applied for 6-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B: 6-hour-Placebo

Part B: VP-102 24-hour

Placebo will be applied for 24-hours and removed. VP-102 is applied every 21 days for 4 treatments.

Part B: 24-hour-Placebo

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Baseline number of treatable external genital warts

Due to logistical and/or scheduling difficulties related to the SARS-CoV-2 (coronavirus-19; COVID-19) pandemic during the course of the study, six subjects discontinued due to COVID-19 related reasons.

Susan Cutler, VP, Medical Affairs

Part B summary is pooled with its respective treatments from Part A.

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

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

Treatment Visit 2 - Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 4 Part B summary is pooled with its respective treatments from Part A.

Study Day 84 EOT Visit - Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112 - Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS - Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Yes, Complete Clearance

Treatment Visit 3: Yes, Complete Clearance

Treatment Visit 4: Yes, Complete Clearance

Study Day 84 EOT: Yes, Complete Clearance

F/U Visit Day 112: Yes, Complete Clearance

F/U Visit Day 147: Yes, Complete Clearance

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 Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3 Part B summary is pooled with its respective treatments from Part A.

Study Day84 EOT Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112 Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS Part B summary is pooled with its respective treatments from Part A.

Study Day 84 EOT Visit Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Incidence of >=90% Clearance: YES

Treatment Visit 3: Incidence of >=90% Clearance: YES

Treatment Visit 4: Incidence of >=90% Clearance: YES

Study Day 84 EOT: Incidence of >=90% Clearance: YES

F/U Visit Day 112: Incidence of >=90% Clearance: YES

F/U Visit Day 147: Incidence of >=90% Clearance: YES

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: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT) visit: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT) Visit: Part B summary is pooled with its respective treatments from Part A.

Follow-up visit day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up visit day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2: Incidence of >=75% Clearance: YES

Treatment Visit 3: Incidence of >=75% Clearance: YES

Treatment Visit 4: Incidence of >=75% Clearance: YES

Study Day 84 EOT: Incidence of >=75% Clearance: YES

F/U Visit Day 112: Incidence of >=75% Clearance: YES

F/U Visit Day 147: Incidence of >=75% Clearance: YES

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 Visit: Part B summary is pooled with its respective treatments from Part A.

Follow-up day 112: Part B summary is pooled with its respective treatments from Part A.

Treatment visit 2: Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 3: Degrees of freedom associated with the error term were computed using Kenward-Rogers method.

Treatment visit 4: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT): Part B summary is pooled with its respective treatments from Part A.

Follow up day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Treatment Visit 2

Treatment Visit 3

Treatment Visit 4

Study Day 84 EOT Visit

Follow up Day 112

Follow-up Visit 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)

Study Day 84 End of Treatment Visit: Part B summary is pooled with its respective treatments from Part A.

Follow up Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.

Follow-up Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 End of Study: Part B summary is pooled with its respective treatments from Part A.

Study Day 84 End of Treatment Visit

Follow up Visit Day 147 End of Study

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 EOT: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 112: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 EOS: Part B summary is pooled with its respective treatments from Part A.

F/U Visit Day 112

F/U Visit 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)

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)

Study Day 84 (EOT: Part B summary is pooled with its respective treatments from Part A.

Study Day 112 (EOT: Part B summary is pooled with its respective treatments from Part A.

Follow-up Visit Day 147 (EOS): Part B summary is pooled with its respective treatments from Part A.

Study Day 84 (EOT)

Follow-up Day 112

Follow-up Visit 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)

Follow-up 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)

VP-102 and applicator: In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

Part A: VP-102 6-hour Group

Part A: VP-102 24-hour Group

This includes 3 subjects that received placebo (1 each for the 2-hour; 6-hour and 24-hour)

VP-102 and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

Placebo and applicator: For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.

Part B: Placebo 6-hour

Part B: Placebo 24-hour

Overall Study

Open label of VP-102 cantharidin topical film forming solution, using the VP-102 applicator.

VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.

VP-102 Cantharidin topical film forming solution

VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments.

VP-102 Cantharidin, topical film forming solution

Adnan Nasir, MD

This is a Phase 2, open label study (Study number VP-102-105; referred to as COVE-1 \[Cantharidin and Occlusion in Verruca Epithelium\]) to evaluate the efficacy, safety and tolerability of VP-102 treatment in subjects with common warts. This study has two Cohorts.

The first Cohort (Cohort 1) utilizes a treatment interval of at least 14 days between treatments with longer treatment intervals being allowed depending on a specific patient's clinical response.Twenty Subjects (2 years and older) are targeted completing End of Study (EOS) visit in Cohort 1.

The second Cohort (Cohort 2) utilizes a treatment interval of 21 days between treatments. Paring of lesions is allowed. Approximately 35 subjects (12 years and older) will be enrolled in Cohort 2. Up to 4 sites will participate in the study.

This study has 2 cohorts. Cohort 1 of the study enrolled 21 subjects and has completed all subject related study activities. Analysis is to be conducted at Day 84. Cohort 2 will utilize 4 sites with an enrollment of approximately 35 subjects. The primary analysis will be conducted at Day 84 with an additional period of follow up out to Day 147.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Post-Licensure Study of the Safety of GARDASIL™ in Males (V501-070)	NCT01567813	Human Papilloma...		9 Years - 26 Years	Merck Sharp & Dohme LLC
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.
Cantharidin and Occlusion in Verruca Epithelium	NCT03487549	Common Wart Warts Hand Warts Papillomavirus ... DNA Virus Infec... Skin Diseases, ... Skin Diseases, ... Skin Diseases Virus Diseases Tumor Virus Inf... Verruca Vulgari... Verruca	VP-102 Canthari... VP-102 Canthari...	2 Years -	Verrica Pharmaceuticals Inc.
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population	NCT01598779	Condylomata Acu...		15 Years - 45 Years	University of Buenos Aires
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.
Human Papillomavirus (HPV) Types Present in External Genital Warts (EGW) in the Argentinean Population	NCT01598779	Condylomata Acu...		15 Years - 45 Years	University of Buenos Aires
Cantharidin and Occlusion in Verruca Epithelium	NCT03487549	Common Wart Warts Hand Warts Papillomavirus ... DNA Virus Infec... Skin Diseases, ... Skin Diseases, ... Skin Diseases Virus Diseases Tumor Virus Inf... Verruca Vulgari... Verruca	VP-102 Canthari... VP-102 Canthari...	2 Years -	Verrica Pharmaceuticals Inc.
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts	NCT03981822	Condylomata Acu... Papillomavirus ... Skin Diseases, ... Skin Diseases, ... Skin Diseases Sexually Transm... Sexually Transm... Warts	VP-102 and appl... Placebo	18 Years -	Verrica Pharmaceuticals Inc.

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