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RECRUITING
NCT06917690
PHASE3

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

Sponsor: Chiesi Farmaceutici S.p.A.

View on ClinicalTrials.gov

Summary

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.

Official title: Multi-centeR, Open-label Study to EValuate the Safety, Efficacy, and Pharmacokinetics of FIlsuVEz (Oleogel-S10) in Japanese Subjects With Epidermolysis Bullosa (REVIVE)

Key Details

Gender

All

Age Range

21 Days - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-04-18

Completion Date

2029-09

Last Updated

2025-12-22

Healthy Volunteers

No

Interventions

DRUG

Oleogel-S10

Topical gel

Locations (6)

Fukuoka Children's Hospital - Dermatology

Fukuoka, Japan

Kurume University Hospital

Fukuoka, Japan

Kobe University Hospital

Kobe, Japan

Niigata University Medical and Dental Hospital

Niigata, Japan

Toho University Omori Medical Center

Ōta-ku, Japan

Hokkaido University Hospital

Sapporo, Japan