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27.02.2015

Testing a topical skin treatment for EBS, RDEB and JEB: Upcoming phase 3 clinical trial

The clinical trial will assess improved wound healing as well as reduced itch and blistering in EB, and is scheduled to start soon in the USA and Europe.

Scioderm carried out an earlier Phase 2 trial to assess the safety, and effectiveness of its topical skin therapy, SD-101, for people with various types of EB. The Phase 2 trial looked at the improvement in complete wound healing, blistering, itching, and pain. Scioderm believes that, based on the benefits seen to date, SD-101 has the potential to benefit people across the three main types of EB. They also report that SD-101 has been well tolerated to date, with no safety concerns.

Scioderm is therefore now planning a follow-on Phase 3 trial, of 3 months' duration. This study will again investigate complete wound healing, and improvements in blistering, itch, and pain. As the clinical trial needs to assess the effect of the active ingredient, half of the patients will receive a 'placebo', which is the cream without the active ingredient, while the other half will receive active therapy. All patients (whether having received the placebo, or active treatment), who complete the 3 month trial, will be eligible to continue to receive the active therapy when the trial finishes.

The Phase 3 trial is designed to establish the significance of benefits of using the SD-101 cream: establishing statistical significance of benefits is an important step in clinical development of an effective treatment, and needs large numbers of patients to be enrolled in the study. The Phase 3 trial therefore aims to recruit patients across the three main EB subtypes, and will have trial sites at several locations across the United States and Europe.

For more information on the trial, including study site locations, please contact info(at)sdermEBtrials.com or see the Scioderm webpage.

Dr. Clare Robinson, Head of Research, DEBRA International

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DEBRA International provides information and news that may be of interest to people with EB, but does not recommend or endorse products, or participation in any particular clinical trial. We strongly recommend that anyone considering a treatment or clinical trial should also speak with their doctor, or medical team, who helps them manage their EB.

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