Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-01 @ 9:09 PM
Study NCT ID:
NCT02192632
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dermatologists' Educational Demonstration for Epiduo Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 85}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2014-07-14', 'studyFirstSubmitQcDate': '2014-07-15', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentile reduction of non-inflammatory & inflammatory acne lesions', 'timeFrame': '12 weeks', 'description': 'Measurement of decreases in both non-inflammatory \\& inflammatory acne lesions'}], 'secondaryOutcomes': [{'measure': 'Total number of local irriation effect counts (erythema, scaling, dryness, itching)', 'timeFrame': '12 week', 'description': 'Calcuation of total number of local irriation effect counts (erythema, scaling, dryness, itching)'}]}, 'conditionsModule': {'conditions': ['Facial Acne', 'Local Adverse Effects']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the efficacy and tolerability of this combination gel compared with BPO monotherapy in Korean patients, and test clinical practicability of dermatologists' educational demonstration for how to apply this gel in reducing uncomfortable irritations."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate acne were evaluated by Leeds revised acne grade from 2 to 6\n* age: 18-40\n\nExclusion Criteria:\n\n* pregnancy\n* mental illness\n* intake of oral isotretinoin within 6 months\n* application of the other oral or topical acne medications\n* chemical peeling or light based treatments within 6 weeks.'}, 'identificationModule': {'nctId': 'NCT02192632', 'briefTitle': "Dermatologists' Educational Demonstration for Epiduo Application", 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'ADP-BPO'}, 'secondaryIdInfos': [{'id': '1402-051-555', 'type': 'REGISTRY', 'domain': '1402-051-555'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': "Epiduo- dermatologist's detailed instruction", 'description': 'After randomly assigned to side of epiduo application, half of total patients were also re-assigned into detailed instruction for application of epiduo from dermatologist', 'interventionNames': ['Drug: Epiduo once daily with detailed instruction for how to apply it']}, {'type': 'EXPERIMENTAL', 'label': 'Epiduo- drug insert only gruop', 'description': 'After randomly assigned to side of epiduo application, half of total patients were also re-assigned into drug insert only group', 'interventionNames': ['Drug: Epiduo- once daily, simple instruction for application']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'BPO group', 'description': 'After randomly assigned to side of BPO application, patients apply BPO during 12 week', 'interventionNames': ['Drug: BPO once daily']}], 'interventions': [{'name': 'Epiduo once daily with detailed instruction for how to apply it', 'type': 'DRUG', 'armGroupLabels': ["Epiduo- dermatologist's detailed instruction"]}, {'name': 'Epiduo- once daily, simple instruction for application', 'type': 'DRUG', 'armGroupLabels': ['Epiduo- drug insert only gruop']}, {'name': 'BPO once daily', 'type': 'DRUG', 'armGroupLabels': ['BPO group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Joungro', 'country': 'South Korea', 'facility': 'Dermatology, Seoul National University', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dae Hun Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}