A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
Recruiting
Phase 3
Interventional Study
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
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 Days and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 6 (estimated)
- Sponsor
- Chiesi Farmaceutici S.p.A. · Industry
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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…
Trial Locations
Loading…
Loading trial locations…
Eligibility Criteria
Inclusion Criteria:
1. Male or female aged ≥ 21 days
2. Confirmed diagnosis of either JEB or DEB
3. Both biological parents and all 4 grandparents of Japanese descent
4. At least 3 EB wounds that meet the following criteria at the time of enrollment:
* All are located outside of the anogenital …
Contacts