Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
- Conditions
- Anogenital WartsCondylomata AcuminataHuman Papillomavirus Infection
- Interventions
- Drug: Placebo
- Registration Number
- NCT01532102
- Lead Sponsor
- Anaconda Pharma
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AP611074 5% gel AP611074 Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42 Placebo gel Placebo Twice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42
- Primary Outcome Measures
Name Time Method Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment 6 weeks
- Secondary Outcome Measures
Name Time Method Safety and local tolerability Up to 8 weeks Descriptive statistics will be calculated by comparing the number of subjects between Day 1 and Day 42 in each treatment group (active or placebo) presenting AEs, or changes in physical examination, vital signs (blood pressure and pulse rate), 12-lead ECG, clinical laboratory parameters (biochemistry, hematology, urinalysis), and local tolerability (erythema, scaling, stinging, oedema)
Pharmacokinetic evaluation Up to 8 weeks Plasma concentrations of AP611074 will be measured from blood samples once weekly up to 8 weeks in all patients. Data will be summarized with descriptive statistics by nominal sampling time.
Trial Locations
- Locations (4)
Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology
🇦🇷Buenos Aires, Argentina
SGS Aster
🇫🇷Paris, France
Hopital Henri Mondor-Dept of Dermatology
🇫🇷Creteil, France
IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.
🇦🇷Buenos Aires, Argentina