Effect of Transparent, Self-drying Silicone Gel on the Treatment of Hypertrophic Abdominal Scars
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Mahidol University
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Scar thickness
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Silicone gel
Gel containing silicone gel
Intervention: Topical silicone gel (Other)
Vaseline
Gel containing petrolatum gel
Intervention: Vaseline (Other)
Outcomes
Primary Outcomes
Scar thickness
Time Frame: 1, 2 and 5 months after initiation of treatment
Secondary Outcomes
- Clinical assessment on overall scar appearance(1, 2 and 5 months after initiation of treatment)
Investigators
Woraphong Manuskiatti, M.D.
Professor
Mahidol University