Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT04597060
Status:
UNKNOWN
Last Update Posted:
2020-10-22
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}], 'ancestors': [{'id': 'D003095', 'term': 'Collagen Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-15', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-10-15', 'lastUpdatePostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thickness by caliper (mm) - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids', 'timeFrame': '6 months', 'description': 'cthickness by caliper in mm.'}, {'measure': 'Vancouver Scar Scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids', 'timeFrame': '6 months', 'description': 'Vancouver Scar Scale between 0 to 13'}, {'measure': 'Antera Elevation Volume - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids', 'timeFrame': '6 months', 'description': 'Measuring Antera Elevation Volume in mm3'}, {'measure': 'Patient satisfaction quartile scale - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids', 'timeFrame': '6 months', 'description': 'Patient satisfaction quartile scale from 0 - 100%'}, {'measure': 'Physician evaluation quartile score - comparing between Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery and triamcinolone acetonide injection for the treatment of Hypertrophic scars and Keloids', 'timeFrame': '6 months', 'description': 'Physician evaluation quartile score from 0-100%'}], 'secondaryOutcomes': [{'measure': 'Side effect of Thermo-mechanical system, Triamcinolone itself, Injection side effect', 'timeFrame': '6 months'}, {'measure': 'Side effect of Triamcinolone acetonide injection', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Keloid, thermo-mechanical system'], 'conditions': ['Keloid']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the safety and efficacy of Thermo-mechanical system for fractional ablation associated triamcinolone acetonide drug delivery for the treatment of Hypertrophic scars and Keloids.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy volunteers without underlying disease\n* Patient with keloid age more than 6 months and keloid thickness more than 1 mm.\n\nExclusion Criteria:\n\n* Dermatitis or infection on treatment area\n* Suspected cancer on treatment area\n* Immunocompromised host\n* Pregnancy or lactating woman\n* Recieved corticosteroid injection within 2 months'}, 'identificationModule': {'nctId': 'NCT04597060', 'briefTitle': 'The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Safety and Efficacy of Thermo-mechanical System for Fractional Ablation Associated Triamcinolone Acetonide Drug Delivery for the Treatment of Hypertrophic Scars and Keloids', 'orgStudyIdInfo': {'id': 'Si 719/2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Split Keloid - first side', 'interventionNames': ['Device: Thermomechanical system with corticosteroids']}, {'type': 'EXPERIMENTAL', 'label': 'Split Keloid - second side', 'interventionNames': ['Other: corticosteroid injection']}], 'interventions': [{'name': 'Thermomechanical system with corticosteroids', 'type': 'DEVICE', 'description': 'The device in this study using Novoxel - Tixel®', 'armGroupLabels': ['Split Keloid - first side']}, {'name': 'corticosteroid injection', 'type': 'OTHER', 'description': 'corticosteroid injection using TA 10mg/ml', 'armGroupLabels': ['Split Keloid - second side']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Woraphong Manuskiatti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rungsima Wanitphakdeedacha, M.D.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Dermatology, Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'centralContacts': [{'name': 'Prof. Woraphong Manuskiatti, M.D.', 'role': 'CONTACT', 'email': 'woraphong.man@mahidol.ac.th', 'phone': '+6624197000', 'phoneExt': '4333'}, {'name': 'Chadakan Yan, M.D.', 'role': 'CONTACT', 'email': 'chadakanyan4090@gmail.com', 'phone': '+66882334090'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woraphong Manuskiatti, M.D.', 'investigatorAffiliation': 'Mahidol University'}}}}