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17.08.2015

Topical cream for all EB types: Clinical trial now recruiting participants

Phase 3 trial of Scioderm's topical cream for all EB types is planned for 8 sites across Europe, as well as 6 sites in the USA.

Scioderm is currently recruiting patients with simplex, recessive dystrophic, or non-Herlitz junctional types of Epidermolysis Bullosa for its Phase 3 Clinical trial of its topical therapy product, Zorblisa (SD-101).

This topical cream product aims to address closure of wounds and reduction of blistering, as well as the pain, itching and infection that accompanies them. In a recently completed clinical trial in EB patients, Scioderm noted that SD-101 stimulated faster and greater wound closure (more wounds had complete closure) relative to placebo treatment.

The Phase 3 clinical trial is randomized, and will assess the efficacy and safety of daily-applied 'SD-101-6.0' cream versus a placebo (the cream without the active drug) in both adults and children 1 month and older, over the entire body. The primary endpoint assessed is the closure of target wounds that have been present for at least 21 days. Assessment of the target-wound healing is non-invasive (i.e. photographs, and measurements made); there are no biopsies taken.

Participation will involve five visits to the clinical-trial site at which a patient is enrolled, with agreed travel costs reimbursed for each visit. In addition, patients completing the study will be eligible to participate in an open-label study and receive active therapy afterwards.

There will be six sites recruiting patients in the USA, and eight clinical trial centres participating in the trial in the following countries in Europe: Austria (Salzburg); France (two sites, Nice and Paris); Germany (Freiburg); Italy (Milan); UK (London); Netherlands (Groningen) ; and Poland (Warsaw, site not yet open).

For more information on the clinical trial, contact info(at)sdermEBtrials.com.

Further information on patient eligibility to participate in the trial may be found at the clinical-trial website.

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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