Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Condylomata Acuminata | — | UNRESOLVED | — |
| Papillomavirus Infections | — | UNRESOLVED | — |
| Sexually Transmitted Diseases | — | UNRESOLVED | — |
| Sexually Transmitted Diseases, Viral | — | UNRESOLVED | — |
| Skin Diseases | — | UNRESOLVED | — |
| Skin Diseases, Infectious | — | UNRESOLVED | — |
| Skin Diseases, Viral | — | UNRESOLVED | — |
| Warts | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Combination Product | — | UNRESOLVED |
| VP-102 and applicator | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- ACTIVE_COMPARATOR
- label
- Part A: VP-102 2 hour-Active
- description
- 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.
- interventionNames
- Combination Product: VP-102 and applicator
- type
- ACTIVE_COMPARATOR
- label
- Part A: VP-102 6-hour Active
- description
- 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.
- interventionNames
- Combination Product: VP-102 and applicator
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDGuenthner 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