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

This study has been completed.
Information provided by (Responsible Party):
Woraphong Manuskiatti, M.D., Mahidol University Identifier:
First received: February 27, 2010
Last updated: January 24, 2014
Last verified: January 2014
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
Hypertrophic Scars
Other: Topical silicone gel
Other: Vaseline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Participant, 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:

Further study details as provided by Woraphong Manuskiatti, M.D., Mahidol University:

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

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

Enrollment: 38
Study Start Date: January 2010
Study Completion Date: June 2010
Primary Completion Date: June 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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT01078428

Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Principal Investigator: Woraphong - Manuskiatti, M.D. Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
  More Information

Responsible Party: Woraphong Manuskiatti, M.D., Professor, Mahidol University Identifier: NCT01078428     History of Changes
Other Study ID Numbers: Si 193/2009
125/2552(EC4) ( Other Identifier: Siriraj Institutional Review Board )
Study First Received: February 27, 2010
Last Updated: January 24, 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:
Cicatrix, Hypertrophic
Pathological Conditions, Anatomical
Pathologic Processes
Dermatologic Agents processed this record on May 25, 2017