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

NCT06917690 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2025-12-22

No results posted yet for this study

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.

Conditions

  • 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

Interventions

DRUG

Oleogel-S10

Topical gel

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-18
Primary Completion
2026-03-31
Completion
2029-09-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06917690 on ClinicalTrials.gov