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NCT01004536
A Randomized Investigator-blind Multi-center Prospective Study for the Efficacy and Safety of Silicon Gel (Dermatix) in the Prevention of Hypertrophic Scar in Subjects Undergoing Caesarean Section
Phase 4 trial testing silicone gel in Hypertrophic Cicatrix in 47 participants. Status unknown.
1 February 2011
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 47 |
| Start date | 1 October 2010 |
| Primary completion | 1 February 2011 |
| Estimated completion | 1 February 2011 |
| Sites | 3 locations across South Korea |
Drugs / interventions tested
- silicone gel
- no treatment — full drug profile →
Conditions studied
- Hypertrophic Cicatrix — all drugs for Hypertrophic Cicatrix →
Sponsor
Samsung Medical Center
Who can join
Adults 20 to 45, female only, with Hypertrophic Cicatrix. 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.
-
summation of scar scores of modified Vancouver Scar Scale
Time frame: week 12
Sponsor's own description
Silicone gel is a self-drying silicone polymer that forms thin film after application onto the skin. Because silicone film is a medical device, silicone gel is also regarded as a medical device. Silicone gel has been on the market for many years for the management of scar in the phase of treatment as well as in the phase of prevention. In contrast to other methods that are expensive, invasive or inconvenient, silicone gel is convenient, non-invasive and also reasonably priced. However, the number of well-designed clinicial trials for efficacy and safety are not enough to provide robust evidences in making clinical decisions for scar management options. In a prospective, multi-center, investigator-blind randomized half-split study for patients undergoing cesarean sections, the investigators attempt to provide valid information for the efficacy and safety of silicone gel in the prevention phase of scar.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01004536
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of silicone gel
Trials testing the same drug.
- NCT05412745 — Class I Medical Device on Post-surgical Scars · NA · completed
- NCT03601247 — Silicone Gel for Postsurgical Scars of the Eyelid · NA · completed
Other Samsung Medical Center trials
Trials by the same sponsor.
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- NCT07467213 — Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute M · Phase 4 · not yet recruiting
- NCT07530913 — Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients · NA · enrolling by invitation
- NCT07500701 — Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Pro · Phase 3 · recruiting
- NCT07409441 — Korea Acute Myocardial Infarction Registry · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01004536 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samsung Medical Center
- Last refreshed: 9 December 2010
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01004536.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing