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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Woraphong Manuskiatti, M.D., Mahidol University
ClinicalTrials.gov Identifier:
NCT01078428
First received: February 27, 2010
Last updated: January 24, 2014
Last verified: January 2014
  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:


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 ]

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.

  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:
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)
Study First Received: February 27, 2010
Last Updated: January 24, 2014
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 April 14, 2014