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

NCT03981822 | Completed Phase 2 Results FDA Drug FDA Device

• 1 other identifier: VP-102-104
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 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 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.

• 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.

• 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.

Other Outcomes (4)

• 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 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.

• 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)

Study Arms (8)

Part A: VP-102 2 hour-Active

ACTIVE COMPARATOR

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.

Combination Product: VP-102 and applicator

Part A: VP-102 6-hour Active

ACTIVE COMPARATOR

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.

Combination Product: VP-102 and applicator

Part A: VP-102 24-hour Active

ACTIVE COMPARATOR

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.

Combination Product: VP-102 and applicator

Part A: Placebo

PLACEBO COMPARATOR

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.

Combination Product: Placebo

Part B & A: VP-102 6 hour-Active

ACTIVE COMPARATOR

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

Combination Product: VP-102 and applicator

Part B & A: 6-hour-Placebo

PLACEBO COMPARATOR

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

Combination Product: Placebo

Part B & A: VP-102 24-hour Active

ACTIVE COMPARATOR

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.

Combination Product: VP-102 and applicator

Part B & A: 24-hour-Placebo

PLACEBO COMPARATOR

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

Combination Product: Placebo

Interventions

VP-102 and applicator COMBINATION_PRODUCT

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.

Also known as: VP-102 (cantharidin) 0.7% w/v topical solution

Part A: VP-102 2 hour-Active; Part A: VP-102 24-hour Active; Part A: VP-102 6-hour Active; Part B & A: VP-102 24-hour Active; Part B & A: VP-102 6 hour-Active

Placebo COMBINATION_PRODUCT

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

Part A: Placebo; Part B & A: 24-hour-Placebo; Part B & A: 6-hour-Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Verrica Pharmaceuticals Inc.: lead
• Instat Consulting, Inc.: collaborator
• Paidion Research, Inc.: collaborator
• BioClinica, Inc.: collaborator

Study Sites (4)

The Indiana Clinical Trials Center,PC

Plainfield, Indiana, 46168, United States

Location

DelRicht Research

Baton Rouge, Louisiana, 70816, United States

Location

Clarkston Skin Research

Clarkston, Michigan, 48346, United States

Location

DelRicht Research

Tulsa, Oklahoma, 74133, United States

Location

Related Publications (1)

• Guenthner S, McFalda W, Tate M, Eads K, Rieger J, Glover DK, Willson C, Rumney P, Rosen T, Andres J, Olivadoti M. Phase II, Double-Blind, Vehicle-Controlled Study to Determine the Cantharidin Dose Regimen, Efficacy, Safety, and Tolerability of VP-102 in Subjects with External Genital Warts. Am J Clin Dermatol. 2021 Nov;22(6):867-875. doi: 10.1007/s40257-021-00635-2. Epub 2021 Sep 13.

  PMID: 34515985 DERIVED

MeSH Terms

Conditions

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

Interventions

VP-102; Cantharidin

Condition Hierarchy (Ancestors)

Communicable Diseases; Infections; DNA Virus Infections; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzofurans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

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.

Results Point of Contact

• Title: Susan Cutler, VP, Medical Affairs
• Organization: Verrica Pharmaceuticals

scutler@verrica.com

484-773-0898

Study Officials

• Scott Guenthner, MD

  The Indiana Clinical Trials Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 6, 2019
• First Posted: June 11, 2019
• Study Start: June 25, 2019
• Primary Completion: May 21, 2020
• Study Completion: July 8, 2020
• Last Updated: November 27, 2024
• Results First Posted: September 22, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)