Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars - Full Text View

Sponsor:	Mahidol University
Information provided by:	Mahidol University
ClinicalTrials.gov Identifier:	NCT01078428

Purpose

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.

Condition	Intervention	Phase
Keloids Hypertrophic Scars	Other: Topical silicone gel Other: Vaseline	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars

Resource links provided by NLM:

MedlinePlus related topics: Scars

Drug Information available for: Petrolatum

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:

Scar thickness [ Time Frame: 1, 2 and 5 months after initiation of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Clinical assessment on overall scar appearance [ Time Frame: 1, 2 and 5 months after initiation of treatment ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	38
Study Start Date:	January 2010
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Silicone gel Gel containing silicone gel	Other: Topical silicone gel Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks Other Name: Dermatix gel
Placebo Comparator: Vaseline Gel containing petrolatum gel	Other: Vaseline Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

subjects at least 18 years old
subjects with hypertrophic abdominal scar
Have not received treatment on the scar at least 1 month prior to the enrollment.

Exclusion Criteria:

subject who has previous history of silicone allergy
subject who smoke cigarette
subject who was treated with x-rays irradiation in the past

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01078428

Locations

Thailand
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700

Sponsors and Collaborators

Mahidol University

Investigators

Principal Investigator:

Woraphong - Manuskiatti, M.D.

Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

More Information

Publications:

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. Erratum in: Wound Repair Regen. 2008 Jul-Aug;16(4):582.

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. No abstract available.

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.

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. Epub 2006 Jul 11.

Responsible Party:	Woraphong Manuskiatti, M.D., Department of Dermatology, Faculty of Medicine Siiraj Hospital, Mahidol University
ClinicalTrials.gov Identifier:	NCT01078428 History of Changes
Other Study ID Numbers:	Si 193/2009, 125/2552(EC4)
Study First Received:	February 27, 2010
Last Updated:	March 1, 2010
Health Authority:	Thailand: Ethical Committee

Keywords provided by Mahidol University:

Hypertrophic scars
Topical silicone gel
Scar thickness

Scar Color
Scar pliability
Scar appearance

Additional relevant MeSH terms:

Hypertrophy
Keloid
Cicatrix, Hypertrophic
Cicatrix
Pathological Conditions, Anatomical
Collagen Diseases
Connective Tissue Diseases

Fibrosis
Pathologic Processes
Petrolatum
Emollients
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 24, 2012