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

Phase 4
Completed
Conditions
Keloids
Hypertrophic Scars
Interventions
Other: Topical silicone gel
Other: Vaseline
Registration Number
NCT01078428
Lead Sponsor
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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
38
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 & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Silicone gelTopical silicone gelGel containing silicone gel
VaselineVaselineGel containing petrolatum gel
Primary Outcome Measures
NameTimeMethod
Scar thickness1, 2 and 5 months after initiation of treatment
Secondary Outcome Measures
NameTimeMethod
Clinical assessment on overall scar appearance1, 2 and 5 months after initiation of treatment

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital

🇹🇭

Bangkoknoi, Bangkok, Thailand

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