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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01532102
• Date of registration: 12/01/2012
• Prospective Registration: Yes
• Primary sponsor: Anaconda Pharma
• Public title: Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
• Scientific title: 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
• Date of first enrolment: February 28, 2012
• Target sample size: 24
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01532102
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1/Phase 2

Countries of recruitment

Argentina, France

Contacts

• Name: Olivier Chosidow, MD, PhD
• Affiliation: Assistance Publique - Hôpitaux de Paris

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Human Papillomavirus Infection

Anogenital Warts

Condylomata Acuminata

Intervention(s)

Drug: AP611074

Drug: Placebo

Primary Outcome(s)

Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment [Time Frame: 6 weeks]

Secondary Outcome(s)

Safety and local tolerability [Time Frame: Up to 8 weeks]

Pharmacokinetic evaluation [Time Frame: Up to 8 weeks]

Secondary ID(s)

2011-003760-80

AP611074.CT3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors