Clinical trial NCT01532102: Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Anogenital Warts
Condylomata Acuminata
Human Papillomavirus Infection
Keywords: Genital warts
Anogenital warts
HPV
Human papillomavirus
Antiviral
Lead sponsor: Vaxart
Sponsor class: INDUSTRY
First posted: 2012-02-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Genital warts (GW; also called condylomas or condylomata acuminata) are lesions caused by infection of Human papillomavirus (HPV)(specifically HPV-6 or HPV-11 types, found in \> 95% of lesions). GW are sexually transmitted and affect about 1% of the sexually active population. GW represent a distressful condition for social and sexual life, especially in the cases of external condylomas. No HPV-specific antiviral treatment exists to date, and all existing therapies (either surgical or drug) have limited efficacy, with a significant level of GW recurrences and are associated with local skin reactions. AP611074 is a synthetic new chemical entity that is a potent and selective inhibitor of the interaction between two viral proteins from HPV6 and HPV11, an interaction that is a necessary step for HPV DNA replication and thus viral production. AP611074 is the "first in class" specific HPV antiviral described to treat condyloma caused by HPV infection.

Eligibility 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.

Primary outcomes:
measure: Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Safety and local tolerability
timeFrame: Up to 8 weeks
measure: Pharmacokinetic evaluation
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.
city: Buenos Aires
country: Argentina
facility: Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology
city: Creteil
country: France
facility: Hopital Henri Mondor-Dept of Dermatology
city: Paris
country: France
facility: SGS Aster
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier Chosidow, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: