Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-29 @ 1:28 AM
Study NCT ID:
NCT03933033
Status:
COMPLETED
Last Update Posted:
2019-05-01
First Post:
2019-04-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000152', 'term': 'Acne Vulgaris'}, {'id': 'D002921', 'term': 'Cicatrix'}], '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'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-27', 'studyFirstSubmitDate': '2019-04-25', 'studyFirstSubmitQcDate': '2019-04-27', 'lastUpdatePostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in grade of acne scares according toQualitative scarring grading system of Goodman and Baron', 'timeFrame': '6 months', 'description': 'Grade of acne scares improvement after treatment'}, {'measure': 'Change in clinical appearance of acne scare accordinga four-point scale for assessment of clinical improvement of skin smoothness', 'timeFrame': '6 month', 'description': 'improvement of acne scares as evaluated by sequential photos'}, {'measure': 'Change in patient satisfaction usinga four-point scale; Grade 4 highly satisfied, Grade 3 satisfied, Grade 2 neutral and Grade 1 dissatisfied', 'timeFrame': '6 month', 'description': 'increase in patient satisfaction after treatment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Acne scars', 'Erbium-YAG laser', 'platelet-rich plasma'], 'conditions': ['Acne Vulgaris', 'Scars']}, 'referencesModule': {'references': [{'pmid': '31420849', 'type': 'DERIVED', 'citation': 'El-Taieb MA, Ibrahim HM, Hegazy EM, Ibrahim AK, Gamal AM, Nada EA. Fractional Erbium-YAG Laser and Platelet-Rich Plasma as Single or Combined Treatment for Atrophic Acne Scars: A Randomized Clinical Trial. Dermatol Ther (Heidelb). 2019 Dec;9(4):707-717. doi: 10.1007/s13555-019-00318-1. Epub 2019 Aug 16.'}]}, 'descriptionModule': {'briefSummary': 'This study aim to assess the efficacy of Er-YAG laser 2940nm and PRP as a single line of treatment in comparison with combined treatment in atrophic post acne scars.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '38 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patients with atrophic post acne scars classified on the basis of Goodman and Baron's Qualitative classification, no active acne lesions and patients with atrophic scars only\n\nExclusion Criteria:\n\n* patients with positive history of keloidal tendency, positive history of bleeding tendency, platelet disorder, patients with any acute infection on face like, herpes, folliculitis, patients with HIV, HBsAg, patients with a history of autoimmune diseases or patients on immunosuppressive drugs."}, 'identificationModule': {'nctId': 'NCT03933033', 'briefTitle': 'Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars', 'organization': {'class': 'OTHER', 'fullName': 'Aswan University Hospital'}, 'officialTitle': 'Fractional Erbium-YAG Laser Versus Platelet Rich Plasma in the Treatment of Atrophic Acne Scars: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Erbium Yag'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group A', 'description': 'treated with platelet rich plasma', 'interventionNames': ['Procedure: Platelet Rich Plasma']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'treated with Erbium Yag Laser', 'interventionNames': ['Device: Fractional Erbium Yağ Laser']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group C', 'description': 'treated with both line of treatments', 'interventionNames': ['Device: Fractional Erbium Yağ Laser', 'Procedure: Platelet Rich Plasma']}], 'interventions': [{'name': 'Fractional Erbium Yağ Laser', 'type': 'DEVICE', 'description': 'Multiple sessions of Fractional Erbium Yağ Laser', 'armGroupLabels': ['Group B', 'Group C']}, {'name': 'Platelet Rich Plasma', 'type': 'PROCEDURE', 'description': 'Multiple injections of Platelet Rich Plasma', 'armGroupLabels': ['Group A', 'Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81528', 'city': 'Aswān', 'country': 'Egypt', 'facility': 'Aswan University Hospital', 'geoPoint': {'lat': 24.09082, 'lon': 32.89942}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aswan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'South Valley University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ass. Prof. of Dermatology, Venereology and Andrology', 'investigatorFullName': 'Moustafa A. El Taieb', 'investigatorAffiliation': 'Aswan University Hospital'}}}}