Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-26 @ 6:52 AM
Study NCT ID:
NCT02487212
Status:
COMPLETED
Last Update Posted:
2015-07-01
First Post:
2015-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], 'ancestors': [{'id': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002990', 'term': 'Clobetasol'}, {'id': 'D007834', 'term': 'Lasers'}], 'ancestors': [{'id': 'D001623', 'term': 'Betamethasone'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D055618', 'term': 'Radiation Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-06-30', 'studyFirstSubmitDate': '2015-04-11', 'studyFirstSubmitQcDate': '2015-06-30', 'lastUpdatePostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar thickness measured by digital calliper', 'timeFrame': 'change from baseline in scar thickness at 6 months'}], 'secondaryOutcomes': [{'measure': 'Patient and observer scar assessment scale', 'timeFrame': 'Baseline, 1 month after first treatment, 1,3 and 6 months after fourth treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fractional laser', 'hypertrophic scar', 'topical corticosteroid', 'laser assisted delivery systems'], 'conditions': ['Hypertrophic Scars']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of using ablative fractional laser- assisted topical corticosteroid delivery for the treatment of hypertrophic scar.', 'detailedDescription': 'Hypertrophic scars are common conditions that cause persistent symptom and can lead to severe psychosocial impairment. Intralesional corticosteroid have been a mainstay in the treatment of hypertrophic scars. However, there are many disadvantages of corticosteroid injection such as severe pain, skin atrophy, skin thinning, steroid acne, telangiectasia and hypopigmentation.\n\nRecent reports propose new treatment methods for hypertrophic scars with the use of fractional ablative lasers to create zones of ablation of the skin that may assisted the penetration of drugs to the skin.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Female subjects with age range 18-60 years;\n* Subject with hypertrophic scar from abdominal surgery for at least 3 months;\n* Discontinued using oral isotretinoin for 6 months, alpha hydroxy acid or topical retinoic acid for 3 months\n\nExclusion Criteria:\n\n* Subject who has skin Infection, photosensitive dermatosis or inflammatory acne on the treated area;\n* Subject who smoke cigarette;\n* Subject who was treated with Intralesional corticosteroid'}, 'identificationModule': {'nctId': 'NCT02487212', 'briefTitle': 'Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Treatment of Hypertrophic Scars Using Fractional Laser and Fractional Laser-assisted Topical Corticosteroid Delivery', 'orgStudyIdInfo': {'id': '614/2556 (EC2)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Laser+Topical corticosteroid', 'description': 'Hypertrophic scars were treated with fractional Erbium: Yttrium aluminium garnet (YAG) (2,940-nm) laser, then 0.05% Clobetasol propionate ointment was immediately applied on the perforated scar on one side', 'interventionNames': ['Drug: 0.05% Clobetasol propionate', 'Device: Fractional Erbium:Yag (2,940-nm) laser']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Laser+Petrolatum gel', 'description': 'Hypertrophic scars were treated with fractional Erbium: YAG (2,940-nm) laser, then topical petrolatum gel was immediately applied on the perforated scar on the other side', 'interventionNames': ['Drug: Petrolatum gel', 'Device: Fractional Erbium:Yag (2,940-nm) laser']}], 'interventions': [{'name': '0.05% Clobetasol propionate', 'type': 'DRUG', 'description': '0.05% Clobetasol propionate was rubbed for 2 minutes on one side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser. The treatment was done in every 2 weeks for 4 sessions', 'armGroupLabels': ['Laser+Topical corticosteroid']}, {'name': 'Petrolatum gel', 'type': 'DRUG', 'description': 'Petrolatum gel was rubbed for 2 minutes on the other side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser.The treatment was done in every 2 weeks for 4 sessions', 'armGroupLabels': ['Laser+Petrolatum gel']}, {'name': 'Fractional Erbium:Yag (2,940-nm) laser', 'type': 'DEVICE', 'description': 'The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions', 'armGroupLabels': ['Laser+Petrolatum gel', 'Laser+Topical corticosteroid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital, Mahidol University', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woraphong Manuskiatti, M.D.', 'investigatorAffiliation': 'Mahidol University'}}}}