safety and efficacy study of topical ap611074 gel to treat genital warts

Conditions: Anogenital Warts; Condylomata Acuminata; Human Papillomavirus Infection

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).

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.

Keywords: genital warts anogenital warts hpv human papillomavirus antiviral