Condition: Epidermolysis Bullosa · Junctional Epidermolysis Bullosa · Epidermolysis Bullosa, Dystrophic · Sponsor: Chiesi Farmaceutici S.p.A.
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 within 45 days or reduce the size of the wounds? * Are there any medical problems when using Oleogel-S10 gel? * How much of the drug ends up in your blood? The study has 2 parts. In Part 1, participants will: * Apply Oleogel-S10 gel to the EB wound dressings at least once every 4 days for 45 days. * Visit the clinic once every 2 weeks for checkups and tests. If participants complete Part 1, they may participate in Part 2 if they choose to. In Part 2, participants will continue to receive Oleogel-S10 gel until the product is available to buy in Japan or until the trial is stopped by the company.
This description comes directly from the study's public registry record.
Chiesi Clinical Trials · +3905212791 · clinicaltrials_info@chiesi.com
Always discuss trial participation with your own doctor first.
| Fukuoka Children's Hospital - Dermatology | Fukuoka, Japan | Recruiting |
| Kurume University Hospital | Fukuoka, Japan | Recruiting |
| Kobe University Hospital | Kobe, Japan | Recruiting |
| Niigata University Medical and Dental Hospital | Niigata, Japan | Recruiting |
| Toho University Omori Medical Center | Ōta-ku, Japan | Recruiting |
| Hokkaido University Hospital | Sapporo, Japan | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06917690