Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT01532102
Status:
COMPLETED
Last Update Posted:
2018-05-30
First Post:
2012-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003218', 'term': 'Condylomata Acuminata'}, {'id': 'D030361', 'term': 'Papillomavirus Infections'}], 'ancestors': [{'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D014860', 'term': 'Warts'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D014412', 'term': 'Tumor Virus Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2013-05-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-29', 'studyFirstSubmitDate': '2012-01-12', 'studyFirstSubmitQcDate': '2012-02-13', 'lastUpdatePostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete or partial regression of anogenital warts, based on the total lesion surface before and after treatment', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Safety and local tolerability', 'timeFrame': 'Up to 8 weeks', 'description': '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)'}, {'measure': 'Pharmacokinetic evaluation', 'timeFrame': 'Up to 8 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Genital warts', 'Anogenital warts', 'HPV', 'Human papillomavirus', 'Antiviral'], 'conditions': ['Anogenital Warts', 'Condylomata Acuminata', 'Human Papillomavirus Infection']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Main Inclusion Criteria:\n\n* Male or female patient aged between 18 and 55 years.\n* External condylomas, 1-15 lesions, non-confluent and individually isolated.\n* 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.\n* 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".\n* 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.\n* For patients having previous episodes of condyloma lesions, they shouldn\'t have received any condyloma treatment for at least 12 months before screening.\n\nMain Exclusion Criteria:\n\n* 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.\n* 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.\n* Patients with fibroepithelial polyps or scaly non-viral papillomas, seborrheic keratosis, follicular papules, syringoma, or circumscribed lymphangiomas.\n* Patients whose skin condition or coloration would interfere with the observation and the follow-up of the lesions during the study.\n* 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.'}, 'identificationModule': {'nctId': 'NCT01532102', 'briefTitle': 'Safety and Efficacy Study of Topical AP611074 Gel to Treat Genital Warts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vaxart'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'AP611074.CT3'}, 'secondaryIdInfos': [{'id': '2011-003760-80', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AP611074 5% gel', 'description': 'Twice daily application of 100 mg dose of AP611074 5% gel for 41 days followed by a single morning application on Day 42', 'interventionNames': ['Drug: AP611074']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo gel', 'description': 'Twice daily application of 100 mg dose of placebo gel for 41 days followed by a single morning application on Day 42', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AP611074', 'type': 'DRUG', 'otherNames': ['HPV antiviral', 'Anticondyloma drug'], 'armGroupLabels': ['AP611074 5% gel']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo gel manufactured to appear identical to AP611074 5% gel', 'armGroupLabels': ['Placebo gel']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'C1122AAL', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'IADT - Instituto Argentino de Diagnostico y Tratamiento S.A.', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': 'C1181ACH', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'Hospotal Italinao de Buenos Aires - Dept of Dermatology and Gynecology', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': 'Hopital Henri Mondor-Dept of Dermatology', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'SGS Aster', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Olivier Chosidow, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anaconda Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}