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

Human Papillomavirus Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532102
• Other study ID #: AP611074.CT3
• Secondary ID: 2011-003760-80
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 28, 2012
• Est. completion date: May 6, 2013

Study information

• Verified date: May 2018
• Source: Vaxart
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 6, 2013
• Est. primary completion date: May 6, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anogenital Warts
• Condylomata Acuminata
• Human Papillomavirus Infection
• Papillomavirus Infections
• Warts

Intervention

Drug:
• AP611074

• Placebo
Placebo gel manufactured to appear identical to AP611074 5% gel

Locations

Country	Name	City	State
Argentina	Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology	Buenos Aires
Argentina	IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.	Buenos Aires
France	Hopital Henri Mondor-Dept of Dermatology	Creteil
France	SGS Aster	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Anaconda Pharma

Countries where clinical trial is conducted

Argentina,  France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment		6 weeks
Secondary	Safety and local tolerability	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)	Up to 8 weeks
Secondary	Pharmacokinetic evaluation	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.	Up to 8 weeks