Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
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| ClinicalTrials.gov Identifier: NCT01532102 |
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Recruitment Status :
Completed
First Posted : February 14, 2012
Last Update Posted : May 30, 2018
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Sponsor:
Anaconda Pharma
Information provided by (Responsible Party):
Vaxart ( Anaconda Pharma )
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Anogenital Warts Condylomata Acuminata Human Papillomavirus Infection | Drug: AP611074 Drug: Placebo | Phase 1 Phase 2 |
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.
| 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 |
| Actual Study Start Date : | February 28, 2012 |
| Actual Primary Completion Date : | May 6, 2013 |
| Actual Study Completion Date : | May 6, 2013 |
| Arm | Intervention/treatment |
|---|---|
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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 |
Primary Outcome Measures :
- Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment [ Time Frame: 6 weeks ]
Secondary Outcome Measures :
- 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 |
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.
Information from the National Library of Medicine
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
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 |
| 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: | May 30, 2018 |
| Last Verified: | May 2018 |
Keywords provided by Vaxart ( Anaconda Pharma ):
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Genital warts Anogenital warts HPV Human papillomavirus Antiviral |
Additional relevant MeSH terms:
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Warts Papillomavirus Infections DNA Virus Infections Virus Diseases Skin Diseases, Viral |
Tumor Virus Infections Skin Diseases, Infectious Skin Diseases Antiviral Agents Anti-Infective Agents |