A Randomized Comparative Study Evaluating the Tolerability and Efficacy of Two Topical Therapies for the Treatment of Keloids and Hypertrophic Scars

     This study has been completed.

     Summary: This study is currently being undertaken to determine the efficacy and safety of vitamin E lotion (HSE) versus onion extract gel (OE) versus placebo (Cetearyl alcohol [CEA]) in subjects with hypertrophic scars and keloids. While 0.5% hydrocortisone, silicone, HSE, and OE are widely used medicinal over the counter treatments for keloids and hypertrophic scars, their efficacy and safety have not been compared in a blinded, placebo-controlled, prospective fashion. Keloids are thought to result from derailments in the typical wound healing process following cutaneous injury. In this investigator-blinded study, patients will be assigned to one of the three treatment groups: HSE, OE, or CEA. Groups will be randomly assigned and patients will have a two in three chance of receiving treatment with a study medication (HSE or OE). The non-treatment group will receive CEA—a bland lotion that does not contain active ingredients such as steroids, silicone, vitamin E, or onion extract.

     Location: University of Miami, Florida
     Sponsor: University of Miami
     Principle investigator: Brian Berman, MD, PhD, University of Miami, Department of Dermatology
     Identifier: NCT00754247

Genetic Analysis of Familial Keloids

     This study is currently recruiting participants.

     Summary: The purpose of this study is to carefully identify the genes responsible for keloid formation. Keloids are raised scars on the skin that form after a minor injury. The tendency to develop keloids often runs in families. People who have had a classic keloid (butterfly-shaped or wound-overflowing) for at least 1 year may be eligible for this study. In addition to the original participants, family members 12 years or older who have either classic or non-classic keloids and those 18 years or older without keloids can participate. Original participants and family members with keloids will have a medical history focusing on skin issues, particularly keloids and a skin examination. In certain cases, photos of the keloids are taken and all participants will have 35 mm of blood drawn for DNA testing and measurement of blood proteins, including cytokines, which can affect other tissues and cause scarring.

     Location: Bethesda, Maryland
     Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
     Principle investigator: N/A
     Identifier: NCT00008502

Exploratory Study of the Efficacy and Safety of Juvista 250 ng When Administered Following Excision of Ear Lobe Keloids

     This study is currently recruiting participants.

     Summary: This trial will explore the efficacy and safety of 250-ng Juvista per linear centimeter administered by intradermal injection following the excision of ear lobe keloids. Keloids commonly occur after ear piercing and are usually bilateral. One ear lobe will be treated with Juvista and one with placebo. The study design is a randomized, double blind, placebo control study. Age range for participating subjects is 18- to 85-years-old. The subjects must provide written informed consent and they will have bilateral ear lobe keloid scars of comparable size and suitable for surgical excision, which will result in a single wound on each ear lobe no greater than 2-cm long and restricted to the skin, fat, and fibrous tissue of the ear lobe. All laboratory tests must be performed within 28 days of the first trial dose administration.

     Location: Body Aesthetic Plastic Surgery and Skincare Center, St. Louis, Missouri
     Sponsor: Renovo
     Principle investigator: Leroy Young, MD
     Identifier: NCT00836147

The information contained in this update was summarized from www.clinicaltrials.gov.
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