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

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ClinicalTrials.gov Identifier: NCT01078428
Recruitment Status : Completed
First Posted : March 2, 2010
Last Update Posted : January 28, 2014
Sponsor:
Information provided by (Responsible Party):
Woraphong Manuskiatti, M.D., Mahidol University

Brief Summary:
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 or disease Intervention/treatment Phase
Keloids Hypertrophic Scars Other: Topical silicone gel Other: Vaseline Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars
Study Start Date : January 2010
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars
Drug Information available for: Petrolatum
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Scar thickness [ Time Frame: 1, 2 and 5 months after initiation of treatment ]

Secondary Outcome Measures :
  1. Clinical assessment on overall scar appearance [ Time Frame: 1, 2 and 5 months after initiation of treatment ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications:
Responsible Party: Woraphong Manuskiatti, M.D., Professor, Mahidol University
ClinicalTrials.gov Identifier: NCT01078428     History of Changes
Other Study ID Numbers: Si 193/2009
125/2552(EC4) ( Other Identifier: Siriraj Institutional Review Board )
First Posted: March 2, 2010    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014

Keywords provided by Woraphong Manuskiatti, M.D., Mahidol University:
Hypertrophic scars
Topical silicone gel
Scar thickness
Scar Color
Scar pliability
Scar appearance

Additional relevant MeSH terms:
Hypertrophy
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Cicatrix
Fibrosis
Pathologic Processes
Petrolatum
Emollients
Dermatologic Agents