Ignite Creation Date:
2025-12-24 @ 5:20 PM
Ignite Modification Date:
2026-01-22 @ 11:54 AM
Study NCT ID:
NCT01958450
Status:
COMPLETED
Last Update Posted:
2013-10-11
First Post:
2013-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053844', 'term': 'Lasers, Solid-State'}, {'id': 'D054023', 'term': 'Lasers, Semiconductor'}], 'ancestors': [{'id': 'D007834', 'term': 'Lasers'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-09', 'studyFirstSubmitDate': '2013-10-06', 'studyFirstSubmitQcDate': '2013-10-06', 'lastUpdatePostDateStruct': {'date': '2013-10-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Global asessment of acne scar', 'timeFrame': '12 weeks', 'description': '5 point grading of acne scar'}], 'secondaryOutcomes': [{'measure': 'ECCA', 'timeFrame': '12 weeks', 'description': 'quantative assessement of acne scar'}, {'measure': 'adverse effect assessment', 'timeFrame': '12 weeks', 'description': 'adverse effect assessment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acne scar', 'Laser therapy', 'wound healing'], 'conditions': ['Scar']}, 'referencesModule': {'references': [{'pmid': '20331342', 'type': 'BACKGROUND', 'citation': 'Kutlubay Z, Gokdemir G. Treatment of atrophic facial acne scars with the Er:YAG laser: a Turkish experience. J Cosmet Laser Ther. 2010 Apr;12(2):65-72. doi: 10.3109/14764171003706141.'}]}, 'descriptionModule': {'briefSummary': 'Compare the efficacy of frational Er:YAG laser and that of bipolar frequency with diode laser treatment.', 'detailedDescription': 'In acne scar treatment, ablational laser would be superior to nonablative laser treatment. Frational Er:YAG laser treatment is a effective treatment plan for acne scar without severe adverse effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderate acne scar\n\nExclusion Criteria:\n\n* taking steroids, nonsteroidal antiinflammatory drug, and isotretinoin\n* anyone who received acne scar procedures within 6 months\n* underlying diabetes mellitus, keloid, or malignancy'}, 'identificationModule': {'nctId': 'NCT01958450', 'briefTitle': 'Comparison of the Efficacy of Fractional Er:YAG Laser for Acne Scar', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Comparitive Study of Efficacy and Safety Between Fractional Er:YAG Laser and Bipolar Radiofrequency Treatment for Acne Scar', 'orgStudyIdInfo': {'id': '2012-1061'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Er:YAG laser', 'description': 'acne scar treatment using Er:YAG laser', 'interventionNames': ['Procedure: Er:YAG laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bipolar radiofrequency with diode laser', 'description': 'Bipolar radiofrequency with diode laser', 'interventionNames': ['Procedure: Bipolar radiofrequency with diode laser']}], 'interventions': [{'name': 'Er:YAG laser', 'type': 'PROCEDURE', 'description': 'acne scar treatment using Er:YAG laser', 'armGroupLabels': ['Er:YAG laser']}, {'name': 'Bipolar radiofrequency with diode laser', 'type': 'PROCEDURE', 'description': 'acne scar treatment with bipolar radiofrequency combined with diode laser', 'armGroupLabels': ['Bipolar radiofrequency with diode laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Department of Dermatology, Seoul National University College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Dae Hun Suh, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Dermatology, Seoul National University College of Medicine'}, {'name': 'Seonguk Min, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Seoul National University College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Dae Hun Suh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}