A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts (NCT03981822) | Clinical Trial Compass
CompletedPhase 2
A Placebo-Controlled Study Using VP-102 in the Treatment of External Genital Warts
United States105 participantsStarted 2019-06-25
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of Subjects Exhibiting Complete Clearance of All Treatable Warts at the Study Day 84 (End of Treatment) Visit.
Timeframe: Compares baseline wart count to Day 84, end of treatment.