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

Mahidol University

Status and phase: Completed; Phase 4

Conditions: Keloids; Hypertrophic Scars

Treatments: Other: Topical silicone gel; Other: Vaseline

Study type: Interventional

Funder types: Other

Identifiers

NCT01078428

Si 193/2009

125/2552(EC4) (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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38 participants in 2 patient groups, including a placebo group

Silicone gel

Active Comparator group

Description:

Gel containing silicone gel

Treatment:

Other: Topical silicone gel

Vaseline

Placebo Comparator group

Description:

Gel containing petrolatum gel

Treatment:

Other: Vaseline