Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-01-02 @ 4:30 PM
Study NCT ID:
NCT00253305
Status:
COMPLETED
Last Update Posted:
2007-05-30
First Post:
2005-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Gel Anti-Fungal Agent for Tinea Unguium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014009', 'term': 'Onychomycosis'}], 'ancestors': [{'id': 'D014005', 'term': 'Tinea'}, {'id': 'D003881', 'term': 'Dermatomycoses'}, {'id': 'D009181', 'term': 'Mycoses'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D009260', 'term': 'Nail Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'statusVerifiedDate': '2007-05', 'lastUpdateSubmitDate': '2007-05-29', 'studyFirstSubmitDate': '2005-11-13', 'studyFirstSubmitQcDate': '2005-11-13', 'lastUpdatePostDateStruct': {'date': '2007-05-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quanitative improvement in toenail appearance.'}, {'measure': 'Assessment of dermatophyte culture and KOH examination.'}, {'measure': 'Frequency and severity of adverse events.'}], 'secondaryOutcomes': [{'measure': 'Time to achieve 90% and 100% clearance of fungus from nail.'}, {'measure': 'Assessment of treatment success.'}, {'measure': 'Assessment of mycological success.'}]}, 'conditionsModule': {'keywords': ['tinea unguium', 'onychomycosis'], 'conditions': ['Onychomycosis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare, in a controlled fashion, the response to two anti-fungal agents, naftifine or terbinafine, with vehicle in novel topical gel formulations in the treatment of subjects with distal subungual tinea unguium of the toenails (onychomycosis).\n\nThe formulation used as the vehicle for the active agents has been shown in earlier studies to facilitate the penetration of the active agent through fungally-infected nails. This study will examine dose-response and agent differences in terms of efficacy and safety.\n\nOnce the subject has qualified for the study, he/she will be randomly assigned to one of five study groups, dispensed appropriate study medication and instructed to apply one drop to the great toe designated for study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of distal subungual tinuea unguium of one great toenail.\n* between 20 - 65% infected area for target nail\n* 2 mm of clear nail proximally on target nail\n* positive dermatophyte culture and positive KOH test\n* able to sign informed consent\n* understand requirements of study\n* females must be post-menopausal or agree to use approved contraceptives throughout the study\n\nExclusion Criteria:\n\n* patients with nails infected with organisms other than dermatophytes\n* patients with proximal subungual tinea unguium\n* patients with spikes of disease extending to nail matrix\n* patients with more than 5 infected nails\n* patients with confounding problems/ abnormalities of target nail\n* patients with screening lab values more than 20% of normal\n* patients with known hypersensitivity to test material components\n* patients requiring systemic medications that may interfere with study\n* patients with a poor history of compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT00253305', 'briefTitle': 'Topical Gel Anti-Fungal Agent for Tinea Unguium', 'organization': {'class': 'INDUSTRY', 'fullName': 'MediQuest Therapeutics'}, 'officialTitle': 'Phase IIB Efficacy and Safety Study of Four Topical Gel Formulations of Anti-Fungal Agents, MQX-5858, MQX-5859, MQX-5866, and MQX-5867, Versus Vehicle in the Treatment of Tinea Unguium.', 'orgStudyIdInfo': {'id': 'MQT-05-001'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Organogel of naftifine, 2%', 'type': 'DRUG'}, {'name': 'Organogel of terbinafine, 2%', 'type': 'DRUG'}, {'name': 'Organogel of naftifine, 6%', 'type': 'DRUG'}, {'name': 'Organogel of terbinafine, 6%', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85741', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Genova Clinical Research, Inc.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '33140', 'city': 'Miami Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Greater Miami Skin and Laser Center', 'geoPoint': {'lat': 25.79065, 'lon': -80.13005}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '97210', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Northwest Cutaneous research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MediQuest Therapeutics', 'class': 'INDUSTRY'}}}}