Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-05 @ 12:13 PM
Study NCT ID:
NCT03178994
Status:
COMPLETED
Last Update Posted:
2019-02-08
First Post:
2017-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-06', 'studyFirstSubmitDate': '2017-06-06', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2019-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total numbers of acne reduction', 'timeFrame': '10 weeks', 'description': 'the difference of acne count (total numbers of acne before treatment - total numbers of acne after treatment)'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who achieve clear or almost clear after treatment', 'timeFrame': '10 weeks', 'description': 'clear or almost clear scored by Adult Female Acne Scoring Tool'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post - adolescence acne', 'Topical 2% ketoconazole cream'], 'conditions': ['Post - Adolescence Acne']}, 'descriptionModule': {'briefSummary': 'To study efficacy (total numbers of acne reduction) and safety of 2% Ketoconazole cream in Thai females with Mild degree Post-Adolescence acne comparing with placebo for a period of 12 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '25 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular menstrual cycle with mild degree of post - adolescence acne\n* agree to stop topical and systemic medication for acne treatment for 2 and 4 weeks respectively.\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Other active rashes on faces.\n* Allergic to ketoconazole or other ingredients of preparation.\n* Signs of hyperandrogenism\n* Taking anti-androgenic medications.'}, 'identificationModule': {'nctId': 'NCT03178994', 'briefTitle': 'The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'The Study of Efficacy and Safety of 2% Ketoconazole Cream in Thai Females With Mild Degree of Post - Adolescence Acne', 'orgStudyIdInfo': {'id': '317/60'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2% ketoconazole cream', 'description': '2% ketoconazole cream apply on face twice daily for 10 weeks.', 'interventionNames': ['Drug: 2% ketoconazole cream']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Hydrophilic cream (in-house preparation) apply on face twice daily for 10 weeks.', 'interventionNames': ['Drug: Hydrophilic Cream']}], 'interventions': [{'name': '2% ketoconazole cream', 'type': 'DRUG', 'description': '2% ketoconazole cream applies twice daily', 'armGroupLabels': ['2% ketoconazole cream']}, {'name': 'Hydrophilic Cream', 'type': 'DRUG', 'description': 'Hydrophilic cream (in-house preparation) applies twice daily', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Department of Medicine, Faculty of Medicine, Chulalongkorn University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Chanat Kumtornrut, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chulalongkorn University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}