Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2026-02-21 @ 9:24 PM
Study NCT ID:
NCT02313467
Status:
COMPLETED
Last Update Posted:
2015-03-17
First Post:
2014-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical PDT Cream Without Irradiation Source in the Acne Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}], 'ancestors': [{'id': 'D017486', 'term': 'Acneiform Eruptions'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012625', 'term': 'Sebaceous Gland Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-10', 'studyFirstSubmitDate': '2014-12-08', 'studyFirstSubmitQcDate': '2014-12-09', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent change of inflammatory acne lesions compared with baseline', 'timeFrame': '12 week'}], 'secondaryOutcomes': [{'measure': 'Percent change of non-inflammatory acne lesions compared with baseline', 'timeFrame': '12 week'}, {'measure': 'Percent change of overall severity of acne lesions compared with baseline', 'timeFrame': '12 week'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Acne, Photodynamic Therapy']}, 'descriptionModule': {'briefSummary': 'In this study, the investigators are going to compare the clinical effect and safety of topical application of 1.5% Butenyl ALA cream formula without light source irradiation in the treatment of acne.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild to moderate acne vulgaris (Leeds revised acne grading system score 2-7) at baseline.\n\nExclusion Criteria:\n\n* known pregnancy\n* lactation\n* any medical illness that might influence the results of the study\n* a history of oral acne medication or surgical procedure, including laser treatment, within 6 months of study enrollment\n* use of topical acne medication within 4 weeks of study enrollment.'}, 'identificationModule': {'nctId': 'NCT02313467', 'briefTitle': 'Topical PDT Cream Without Irradiation Source in the Acne Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Topical Application of 1.5% Butenyl ALA Without Light Source Irradiation in the Treatment of Acne: a Double Blinded Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'SNUH-PDT2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1.5% Butenyl ALA', 'description': 'Topical application of 1.5% Butenyl ALA per every other day around acne lesions in the face', 'interventionNames': ['Drug: Topical application of 1.5% Butenyl ALA']}, {'type': 'SHAM_COMPARATOR', 'label': 'Control', 'description': 'Topical application of sham control per every other day around acne lesions in the face', 'interventionNames': ['Drug: Topical application of sham control']}], 'interventions': [{'name': 'Topical application of 1.5% Butenyl ALA', 'type': 'DRUG', 'armGroupLabels': ['1.5% Butenyl ALA']}, {'name': 'Topical application of sham control', 'type': 'DRUG', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'state': 'Seoul Metropolitan', 'country': 'South Korea', 'facility': 'Seoul National Unviersity', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dae Hun Suh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Department of Dermatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dae Hun Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}