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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aviragen Therapeutics ( Anaconda Pharma )
ClinicalTrials.gov Identifier:
NCT01532102
First received: January 12, 2012
Last updated: January 22, 2016
Last verified: January 2016
  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:


Further study details as provided by Aviragen Therapeutics:

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.


Enrollment: 24
Study Start Date: February 2012
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 appear identical to 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 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

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Argentina
IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.
Buenos Aires, Argentina, C1122AAL
Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology
Buenos Aires, Argentina, C1181ACH
France
Hopital Henri Mondor-Dept of Dermatology
Creteil, France, 94010
SGS Aster
Paris, France, 75014
Sponsors and Collaborators
Anaconda Pharma
Investigators
Principal Investigator: Olivier Chosidow, MD, PhD Assistance Publique - Hôpitaux de Paris
  More Information

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: January 22, 2016
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica

Keywords provided by Aviragen Therapeutics:
Genital warts
Anogenital warts
HPV
Human papillomavirus
Antiviral

Additional relevant MeSH terms:
Warts
Papillomavirus Infections
DNA Virus Infections
Virus Diseases
Skin Diseases, Viral
Tumor Virus Infections
Skin Diseases, Infectious
Skin Diseases
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on July 25, 2016