Ignite Creation Date:
2025-12-26 @ 11:12 AM
Ignite Modification Date:
2025-12-31 @ 11:50 PM
Study NCT ID:
NCT01078428
Status:
COMPLETED
Last Update Posted:
2014-01-28
First Post:
2010-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007627', 'term': 'Keloid'}, {'id': 'D017439', 'term': 'Cicatrix, Hypertrophic'}], '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': 'D020034', 'term': 'Silicone Gels'}, {'id': 'D010577', 'term': 'Petrolatum'}], 'ancestors': [{'id': 'D012828', 'term': 'Silicones'}, {'id': 'D012833', 'term': 'Siloxanes'}, {'id': 'D017646', 'term': 'Organosilicon Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-24', 'studyFirstSubmitDate': '2010-02-27', 'studyFirstSubmitQcDate': '2010-03-01', 'lastUpdatePostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Scar thickness', 'timeFrame': '1, 2 and 5 months after initiation of treatment'}], 'secondaryOutcomes': [{'measure': 'Clinical assessment on overall scar appearance', 'timeFrame': '1, 2 and 5 months after initiation of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hypertrophic scars', 'Topical silicone gel', 'Scar thickness', 'Scar Color', 'Scar pliability', 'Scar appearance'], 'conditions': ['Keloids', 'Hypertrophic Scars']}, 'referencesModule': {'references': [{'pmid': '17727466', 'type': 'BACKGROUND', 'citation': 'Kloeters O, Tandara A, Mustoe TA. Hypertrophic scar model in the rabbit ear: a reproducible model for studying scar tissue behavior with new observations on silicone gel sheeting for scar reduction. Wound Repair Regen. 2007 Sep-Oct;15 Suppl 1:S40-5. doi: 10.1111/j.1524-475X.2007.00224.x.'}, {'pmid': '16756266', 'type': 'BACKGROUND', 'citation': 'Murison M, James W. Preliminary evaluation of the efficacy of dermatix silicone gel in the reduction of scar elevation and pigmentation. J Plast Reconstr Aesthet Surg. 2006;59(4):437-9. doi: 10.1016/j.bjps.2005.09.037. No abstract available.'}, {'pmid': '16163087', 'type': 'BACKGROUND', 'citation': 'Chan KY, Lau CL, Adeeb SM, Somasundaram S, Nasir-Zahari M. A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound. Plast Reconstr Surg. 2005 Sep 15;116(4):1013-20; discussion 1021-2. doi: 10.1097/01.prs.0000178397.05852.ce.'}, {'pmid': '16837136', 'type': 'BACKGROUND', 'citation': 'Li-Tsang CW, Lau JC, Choi J, Chan CC, Jianan L. A prospective randomized clinical trial to investigate the effect of silicone gel sheeting (Cica-Care) on post-traumatic hypertrophic scar among the Chinese population. Burns. 2006 Sep;32(6):678-83. doi: 10.1016/j.burns.2006.01.016. Epub 2006 Jul 11.'}]}, 'descriptionModule': {'briefSummary': 'Keloids and hypertrophic scars are a common subject of dermatologic consultations. Therapeutic management of such conditions remains challenging because of their high rate of recurrence and lack of curative treatment.', 'detailedDescription': 'Silicone gel Sheeting (SGS) is one treatment modality that has proven effective for treatment of hypertrophic scar. One disadvantage of SGS is its application technique. To be effective, SGS must be applied on the scar for at least 12 hours daily. Topical silicone gel is a novel therapy that has shown promising result on scar prevention. However, the efficacy and safety of topical silicone gel for treatment of hypertrophic scar has not been confirmed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subjects at least 18 years old\n* subjects with hypertrophic abdominal scar\n* Have not received treatment on the scar at least 1 month prior to the enrollment.\n\nExclusion Criteria:\n\n* subject who has previous history of silicone allergy\n* subject who smoke cigarette\n* subject who was treated with x-rays irradiation in the past'}, 'identificationModule': {'nctId': 'NCT01078428', 'briefTitle': 'Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars', 'orgStudyIdInfo': {'id': 'Si 193/2009'}, 'secondaryIdInfos': [{'id': '125/2552(EC4)', 'type': 'OTHER', 'domain': 'Siriraj Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Silicone gel', 'description': 'Gel containing silicone gel', 'interventionNames': ['Other: Topical silicone gel']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Vaseline', 'description': 'Gel containing petrolatum gel', 'interventionNames': ['Other: Vaseline']}], 'interventions': [{'name': 'Topical silicone gel', 'type': 'OTHER', 'otherNames': ['Dermatix gel'], 'description': 'Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks', 'armGroupLabels': ['Silicone gel']}, {'name': 'Vaseline', 'type': 'OTHER', 'description': 'Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks', 'armGroupLabels': ['Vaseline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Faculty of Medicine Siriraj Hospital'}], 'overallOfficials': [{'name': 'Woraphong - Manuskiatti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Woraphong Manuskiatti, M.D.', 'investigatorAffiliation': 'Mahidol University'}}}}