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

Sexually Transmitted Diseases Clinical Trial

— CARE-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03981822
• Other study ID #: VP-102-104
• Status: Completed
• Phase: Phase 2
• Start date: June 25, 2019
• Est. completion date: July 8, 2020

Study information

• Verified date: August 2021
• Source: Verrica Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: July 8, 2020
• Est. primary completion date: May 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Combination Product:
• 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.
• Placebo
The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin

Locations

Country	Name	City	State
United States	DelRicht Research	Baton Rouge	Louisiana
United States	Clarkston Skin Research	Clarkston	Michigan
United States	The Indiana Clinical Trials Center,PC	Plainfield	Indiana
United States	DelRicht Research	Tulsa	Oklahoma

Sponsors (4)

Lead Sponsor	Collaborator
Verrica Pharmaceuticals Inc.	BioClinica, Inc., Instat Consulting, Inc., Paidion Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Other	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).	Complete clearance compared from Day 84 to follow-up days 112 and 147.
Other	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).	Baseline to Study Day 84, Follow-up Visits at Days 112 and 147 (EOS)
Other	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).	Baseline to Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)
Primary	Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.	Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at the Study Day 84 EOT Visit.	Compares baseline wart count to Day 84, end of treatment.
Secondary	Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)	Proportion of subjects exhibiting complete clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).	Clearance compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Secondary	Proportion of Subjects Exhibiting 90% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)	Proportion of subjects exhibiting 90% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).	Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Secondary	Proportion of Subjects Exhibiting 75% Clearance of All Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)	Proportion of subjects exhibiting 75% clearance of all treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).	Compared from baseline to each study visit, treatment 2, (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Secondary	Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)	Change from baseline in the number of treatable warts (baseline and new) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).; Number of warts present were recorded at each treatment visit as well as follow-up visits. For each post baseline treatment visit, the change in number of warts from baseline was calculated.	Compared from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.
Secondary	Percent Change From Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS)	Percent Change from Baseline in the Number of Treatable Warts (Baseline and New) at Treatment Visit 2, Treatment Visit 3, Treatment Visit 4, at Study Day 84 (EOT), and Follow-up Visits on Study Day 112 and Study Day 147 (EOS).	Percent change from baseline to each study visit, treatment 2 (Day 21), 3 (Day 42), 4 (Day 63) and Day 84, 112 and 147.