Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
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ClinicalTrials.gov Identifier: NCT01532102 |
Recruitment Status
:
Completed
First Posted
: February 14, 2012
Last Update Posted
: January 26, 2016
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anogenital Warts Condylomata Acuminata Human Papillomavirus Infection | Drug: AP611074 Drug: Placebo | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | February 2012 |
Actual Primary Completion Date : | May 2013 |

Arm | Intervention/treatment |
---|---|
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
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Drug: AP611074
Other Names:
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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
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Drug: Placebo
Placebo gel manufactured to appear identical to AP611074 5% gel
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- Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment [ Time Frame: 6 weeks ]
- Safety and local tolerability [ Time Frame: 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 [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01532102
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 |
Principal Investigator: | Olivier Chosidow, MD, PhD | Assistance Publique - Hôpitaux de Paris |
Responsible Party: | Anaconda Pharma |
ClinicalTrials.gov Identifier: | NCT01532102 History of Changes |
Other Study ID Numbers: |
AP611074.CT3 2011-003760-80 ( EudraCT Number ) |
First Posted: | February 14, 2012 Key Record Dates |
Last Update Posted: | January 26, 2016 |
Last Verified: | January 2016 |
Keywords provided by Aviragen Therapeutics ( Anaconda Pharma ):
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 |