Who is sponsoring NCT00754247?

NCT00754247 is sponsored by University of Miami.

What condition does NCT00754247 study?

NCT00754247 studies Keloid, Hypertrophic Scar, Cicatrix, Hypertrophic.

What drugs are being tested in NCT00754247?

Interventions: 0.5% hydrocortisone, silicone, vitamin E lotion, Onion extract gel, Cetearyl alcohol lotion.

What is the status of NCT00754247?

NCT00754247 is currently COMPLETED.

Last reviewed 2019-06-17 · How we verify

A Prospective, Randomized, Investigator-blinded, Placebo-controlled, Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars

NCT00754247 Phase 4 COMPLETED Results posted

Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. Current treatment options for keloids include intralesional corticosteroids, silicone gel sheeting, compression, surgery and adjuvants to surgery, including radiation and cryotherapy. 0.5% hydrocortisone, silicone, vitamin E lotion (HSE) and onion extract gel (OE) are widely used over-the-counter medications for the treatment of keloids and hypertrophic scars. However, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. This study is being undertaken to determine the efficacy and safety of HSE versus OE versus placebo (Cetearyl alcohol; CEA) in subjects with hypertrophic scars and keloids. This is an investigator-blinded study, which means that the doctor evaluating you will not know if you are receiving the study medication or not. Another doctor will be supplying you with the medication and discussing any problems that you may have with the medication. You will be assigned to one of the three treatment groups: HSE, OE, or CEA. The group will be assigned by chance and you will have two in three chances of receiving treatment with a study medication, HSE or OE. The no treatment group will receive CEA, a bland lotion, containing no active ingredients such as steroids, silicone, vitamin E, or onion extract.

Details

Lead sponsor	University of Miami
Phase	Phase 4
Status	COMPLETED
Enrolment	30
Start date	2006-03
Completion	2008-02

Conditions

Keloid
Hypertrophic Scar
Cicatrix, Hypertrophic

Interventions

0.5% hydrocortisone, silicone, vitamin E lotion
Onion extract gel
Cetearyl alcohol lotion

Primary outcomes

Change in Lesion Volume — Assessed at Baseline visit (week 0) and week 16
Blinded investigator assessed the scar volume by using an alginate impression.

Countries

United States