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

Study acronym: REVIVE
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated December 22, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Site contacts updated at 6 of 6 sitesv4
  2. Study sites: 3 to 6v3
  3. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Apr 2025 to Apr 18, 2025 · Eligibility criteria revised · Site details revised at 3 of 3 sitesv2 Show 3 more changesShow less
    • Start date changed from estimate of Apr 2025 to Apr 18, 2025
    • Eligibility criteria revised
    • Site details revised at 3 of 3 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06917690
Lead Sponsor Chiesi Farmaceutici S.p.A.
Conditions Epidermolysis Bullosa, Junctional Epidermolysis Bullosa, Epidermolysis Bullosa, Dystrophic, Epidermolysis Bullosa, Junctional, Skin Abnormalities, Connective Tissue Disease, Collagen Diseases, Skin Diseases +2 more
Enrollment 6 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov