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

January 24, 2014 updated by: Woraphong Manuskiatti, M.D., Mahidol University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

38

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Scar thickness
Time Frame: 1, 2 and 5 months after initiation of treatment
1, 2 and 5 months after initiation of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Clinical assessment on overall scar appearance
Time Frame: 1, 2 and 5 months after initiation of treatment
1, 2 and 5 months after initiation of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Woraphong - Manuskiatti, M.D., Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2010

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

February 27, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (Estimate)

March 2, 2010

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si 193/2009
  • 125/2552(EC4) (Other Identifier: Siriraj Institutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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