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OpenTrials
Completed

NCT Number: NCT01078428

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

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.

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Key information

Conditions

Keloids Cicatrix Cicatrix, Hypertrophic Collagen Diseases Connective Tissue Diseases Fibrosis Hypertrophic Scars Keloid Pathologic Processes Pathological Conditions, Signs and Symptoms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Faculty of Medicine Siriraj Hospital

Bangkoknoi, Bangkok, 10700, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Topical silicone gel

Other

Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks

Other names: Dermatix gel

Vaseline

Other

Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks

Primary outcomes

  1. Scar thickness

    Time frame: 1, 2 and 5 months after initiation of treatment

Secondary outcomes

  1. Clinical assessment on overall scar appearance

    Time frame: 1, 2 and 5 months after initiation of treatment

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 2, 2010
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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