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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01078428
Enrollment
38
Registered
2010-03-02
Start date
2010-01-31
Completion date
2010-06-30
Last updated
2014-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Keloids, Hypertrophic Scars

Keywords

Hypertrophic scars, Topical silicone gel, Scar thickness, Scar Color, Scar pliability, Scar appearance

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.

Interventions

OTHERTopical silicone gel

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

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

Sponsors

Mahidol University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Scar thickness1, 2 and 5 months after initiation of treatment

Secondary

MeasureTime frame
Clinical assessment on overall scar appearance1, 2 and 5 months after initiation of treatment

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026