Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts - Full Text View

Purpose

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).

Condition	Intervention	Phase
Anogenital Warts Condylomata Acuminata Human Papillomavirus Infection	Drug: AP611074 Drug: Placebo	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Genital Warts Warts

U.S. FDA Resources

Further study details as provided by Anaconda Pharma:

Primary Outcome Measures:

Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and local tolerability [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: Yes ]
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 [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
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.

Estimated Enrollment:	24
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: AP611074 5% gel Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42	Drug: AP611074 Other Names: HPV antiviral Anticondyloma drug
Placebo Comparator: Placebo gel Twice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42	Drug: Placebo Placebo gel manufactured to mimic AP611074 5% gel

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 do not affect the vital prognostic of a patient, but 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) are not completely efficient, show 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 pathologies caused by HPV infection.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Main Inclusion Criteria:

External condylomas, 1-15 lesions, non-confluent and individually isolated
Lesions must not be internal; their visualization must be complete and easily documented by digital pictures.
Lesions to be treated should have appeared between 1-6 months before screening, and should not have received any treatment since appearance.
Non smoker or light smoker (< 10 cigarettes/day).
Certified as healthy by a comprehensive clinical assessment.
Having given a written informed consent prior to selection.
For female patients: negative pregnancy test; postmenopausal woman with amenorrhea for at least 2 years, or female of childbearing potential using one acceptable birth control method until the end of the study.
Ability to comply with protocol requirements.
In agreement with the local law for biomedical experimentation.

Main Exclusion Criteria:

Patients with VIN or PIN (ie,bowenoid papulosis), or genital disease requiring treatment (ie, lichen sclerosus, lichen planus, lichen simplex chronicus, dermatitis, psoriasis, bullous diseases, systemic diseases with genital manifestations).
Patients with fibroepithelial polyps or scaly non-viral papillomas, seborrheic keratosis, follicular papules, syringoma or circumscribed lymphangiomas.
Patients who received any condyloma treatment during 12 months before screening.
Patients whose skin condition or coloration would interfere with the observation and the follow-up of the lesions during the study.
Patients with any clinically significant abnormality following review of pre-study laboratory tests, vital signs, full physical examination and ECG
Patients with presence or history of any allergy or unusual reactions to drugs or anesthetics.
Patients in the exclusion period of a previous study or participated in a study during the last 3 months.
Patients who cannot be contacted in case of emergency.
Patients with positive HBs or HBc antigen or anti HCV antibody, or positive results for HIV 1 or 2 tests.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01532102

Contacts

Contact: Marta Blumenfeld, PhD

+331 82 28 73 03

mblumenfeld@anacondapharma.com

Locations

France
Hopital Henri Mondor-Dept of Dermatology	Recruiting
Creteil, France, 94010
SGS Aster	Recruiting
Paris, France, 75014

Sponsors and Collaborators

Anaconda Pharma

Investigators

Principal Investigator:

Olivier Chosidow, MD, PhD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided

Responsible Party:	Anaconda Pharma
ClinicalTrials.gov Identifier:	NCT01532102 History of Changes
Other Study ID Numbers:	AP611074.CT3, 2011-003760-80
Study First Received:	January 12, 2012
Last Updated:	September 22, 2012
Health Authority:	France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Anaconda Pharma:

Genital warts
Anogenital warts
HPV
Human papillomavirus
Antiviral

Additional relevant MeSH terms:

Warts
Condylomata Acuminata
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Skin Diseases, Viral

Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Neoplasms
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013