Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts

• Status: Completed
• Trial end date: 2013-05-06
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anaconda Pharma
• Treatments: Antiviral Agents

Criteria

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.