Study to Evaluate Safety and Effectiveness of Oleogel-S10 Gel in Japanese Patients with Epidermolysis Bullosa

What this Trial Is About

Researchers are evaluating the safety and effectiveness of Oleogel-S10 gel in treating skin wounds caused by two inherited forms of epidermolysis bullosa EB, called junctional EB JEB and dystrophic EB DEB, specifically in the Japanese population. This trial aims to find out if Oleogel-S10 gel can close wounds or reduce their size within 45 days, assess its safety, and measure how much of the gel enters the bloodstream. Both children and adults are invited to join this study. Participants apply Oleogel-S10 gel to their EB wound dressings at least once every four days for 45 days in Part 1 of the study. They visit the clinic every two weeks for checkups and tests during this period. Those who complete Part 1 may choose to continue in Part 2, where they keep receiving Oleogel-S10 gel until it becomes available for purchase in Japan or until the study is stopped by the company. During the study, participants will have regular clinic visits for examinations and tests to monitor wound healing, safety, and drug exposure. Researchers will evaluate the gels effect on wounds up to 45 days in Part 1 and up to 90 days in Part 2. Safety and tolerability will be assessed throughout the study, which may continue until 2029. Participants will be supervised closely and asked to follow all study instructions and procedures.

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