NCT01078428

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

Completed Phase 4 Last updated 24 January 2014

What this trial tests

Phase 4 trial testing Topical silicone gel in Keloids in 38 participants. Completed in 1 June 2010.

Timeline

1 January 2010

Primary endpoint
1 June 2010

1 June 2010

Quick facts

Lead sponsor	Mahidol University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	triple
Primary purpose	treatment
Enrollment	38
Start date	1 January 2010
Primary completion	1 June 2010
Estimated completion	1 June 2010
Sites	1 location across Thailand

Drugs / interventions tested

• Topical silicone gel
• Vaseline — full drug profile →

Conditions studied

• Keloids — all drugs for Keloids →
• Hypertrophic Scars — all drugs for Hypertrophic Scars →

Sponsor

Mahidol University

Who can join

18 and older, any sex, with Keloids or Hypertrophic Scars. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

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

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Keloids: Current and emerging therapies.
   Ojeh N, Bharatha A, Gaur U, Forde AL. · · 2020 · cited 60× · PMID 32844039 · DOI 10.1177/2059513120940499
2. Current State of Clinical Trials for Keloid Management: An Analysis of Trials Registered on ClinicalTrials.gov.
   Park S, Li D, Guo L, Xu X. · · 2026 · PMID 42077711 · DOI 10.7759/cureus.106243