Clinical trial · Interventional
Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
A Double-blind, Placebo Controlled, Randomized, Phase IIa Study to Assess the Safety, Tolerability, Efficacy, and Pharmacokinetics of Repeated Topical Applications Over 42 Days of AP611074 5% Gel in Condyloma Patients
NCT01532102CI-TRIAL-00033125completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to determine the safety, tolerability and efficacy of the topical application of AP611074 5% gel during 6 weeks on ano-genital warts caused by human papillomavirus (HPV).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anogenital Warts | — | UNRESOLVED | — |
| Condylomata Acuminata | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AP611074 | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- AP611074 5% gel
- description
- Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42
- interventionNames
- Drug: AP611074
- type
- PLACEBO_COMPARATOR
- label
- Placebo gel
- description
- Twice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Main Inclusion Criteria: * Male or female patient aged between 18 and 55 years. * External condylomas, 1-15 lesions, non-confluent and individually isolated. * Lesions must not be internal (ie, they must not penetrate the urethral meatus, vagina or anal canal); their visualization must be complete by patients and investigators without major facilitation maneuvers and easily documented by digital pictures. * Lesions should have a total surface smaller than 5 cm2, and an individual surface smaller than 1 cm2; lesions should be easily measured using a "French Catheter Scale". * Lesions to be treated should have appeared between 1-6 months before screening and patients should not have received any previous condyloma treatment since their appearance. * For patients having previous episodes of condyloma lesions, they shouldn't have received any condyloma treatment for at least 12 months before screening. Main Exclusion Criteria: * Patients with any history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic or infectious disease that, in the Investigator's judgment, prevents the patients from participating to the study. * Patients with VIN or PIN (intraepithelial neoplasia of vulva or penis; ie, Bowenoid papulosis), or genital disease (ie, lichen sclerosus, lichen planus, lichen simplex chronicus, dermatitis, psoriasis, bullous diseases, systemic diseases with genital manifestations) requiring treatment. * Patients with fibroepithelial polyps or scaly non-viral papillomas, seborrheic keratosis, follicular papules, syringoma, or circumscribed lymphangiomas. * Patients whose skin condition or coloration would interfere with the observation and the follow-up of the lesions during the study. * Patients for whom a proper follow-up of the lesions during the study will not be possible, because of hair growth in the treatment area.
References
Publications (0)
Data not yet available
No reference posted for this study.