A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa

Recruiting Phase 3 Interventional Study
Epidermolysis Bullosa Junctional Epidermolysis Bullosa Epidermolysis Bullosa, Dystrophic Epidermolysis Bullosa, Junctional Skin Abnormalities Connective Tissue Disease Collagen Diseases Skin Diseases Genetic Diseases, Inborn Congenital Abnormalities
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
21 Days and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
6 (estimated)
Sponsor
Chiesi Farmaceutici S.p.A. · Industry
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About This Trial
The goal of this clinical trial is to learn if Oleogel-S10 gel works to treat skin wounds from two types of inherited epidermolysis bullosa (EB): junctional EB (JEB) or dystrophic EB (DEB) in the Japanese population. Children and adults may participate. The trial also looks at the safety of Oleogel-S10 gel. The main questions it will answer are: * Does Oleogel-S10 gel close wounds from JEB or DEB…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Male or female aged ≥ 21 days 2. Confirmed diagnosis of either JEB or DEB 3. Both biological parents and all 4 grandparents of Japanese descent 4. At least 3 EB wounds that meet the following criteria at the time of enrollment: * All are located outside of the anogenital …
Contacts

Chiesi Clinical Trials

+3905212791

clinicaltrials_info@chiesi.com

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