Phase 2
N=105
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts
Condylomata Acuminata · Papillomavirus Infections · Skin Diseases, Viral · Skin Diseases, Infectious · Skin Diseases
Bottom Line
View on ClinicalTrials.gov: NCT03981822 ↗Enrolled (actual)
105
Serious AEs
2.9%
Results posted
Sep 2021
Primary outcome: Primary: Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. — 11; 1; 9; 0 Participants — p=0.0048
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- VP-102 and applicator (Combination_product); Placebo (Combination_product)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Verrica Pharmaceuticals Inc.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit. |
11; 1; 9; 0; 19; 23 | 0.0048 sig |
| 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) |
1; 0; 4; 0; 4; 0 | 0.3642 |
| 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) |
1; 0; 4; 0; 5; 0 | 0.3642 |
| 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) |
5; 0; 6; 1; 8; 0 | 0.0356 sig |
| 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) |
-4.0; -0.3; -5.3; 0.6; -4.4; -1.1 | 0.0021 sig |
| 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) |
-41.4; -6.2; -58.5; -2.6; -49.0; -8.9 | <0.0001 sig |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT03981822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.