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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

Phase 1/Phase 2
18 Years
55 Years
Open (Enrolling)
Anogenital Warts, Condylomata Acuminata, Human Papillomavirus Infection

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Trial Information

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

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


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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment

Outcome Time Frame:

6 weeks

Safety Issue:


Principal Investigator

Olivier Chosidow, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

January 2012

Completion Date:

December 2013

Related Keywords:

  • Anogenital Warts
  • Condylomata Acuminata
  • Human Papillomavirus Infection
  • Genital warts
  • Anogenital warts
  • HPV
  • Human papillomavirus
  • Antiviral
  • Condylomata Acuminata
  • Warts
  • Papillomavirus Infections