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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:
The study has 2 parts. In Part 1, participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oleogel-S10 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oleogel-S10 | Drug | Topical gel |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of Oleogel-S10 in Part I | The number and percentage of closed wounds within Part I (up to Day 45). | Enrollment to 45 days |
| Measure | Description | Time Frame |
|---|---|---|
| To continue to evaluate the efficacy of Oleogel-S10 up to Day 90 in Part II | Evaluations will include the proportion of participants achieving complete wound closure of at least one target wound, the change in surface area of the wound, patient and clinician impression of improvement, frequency of dressing changes, and incidence of wound infections. | Enrollment to 90 days |
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Inclusion Criteria:
Male or female aged ≥ 21 days
Confirmed diagnosis of either JEB or DEB
Both biological parents and all 4 grandparents of Japanese descent
At least 3 EB wounds that meet the following criteria at the time of enrollment:
A female subject must meet one of the following criteria:
If of childbearing potential, she must:
Have a negative pregnancy test result at Screening and Baseline Visits, AND
Agree to use one of the following highly reliable methods of contraception from the day of the informed consent signature until the day after the last Oleogel- S10 application. The following methods are acceptable:
Be of non-childbearing potential, defined as one of the following:
Subject and/or subject's legal representative has been informed about the study, has read and understood the information provided, and has given written informed consent
Subject and/or subject's legal representative is able and willing to follow all study procedures and instructions
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiesi Clinical Trials | Contact | +3905212791 | clinicaltrials_info@chiesi.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fukuoka Children's Hospital - Dermatology | Recruiting | Fukuoka | Japan |
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| To evaluate the safety and tolerability of Oleogel-S10 in Part I and Part II | Safety will be assessed through monitoring of adverse events, physical examinations, clinical laboratory tests (blood and urine samples), and vital signs from baseline up to study completion. | Enrollment through study completion, which is estimated for 2029 |
| To evaluate the extent of systemic exposure to betulin | The concentration of betulin in blood at baseline and on Day 45. | Enrollment to 45 days |
| Kurume University Hospital | Recruiting | Fukuoka | Japan |
|
| Kobe University Hospital | Recruiting | Kobe | Japan |
|
| Niigata University Medical and Dental Hospital | Recruiting | Niigata | Japan |
|
| Toho University Omori Medical Center | Recruiting | Ōta-ku | Japan |
|
| Hokkaido University Hospital | Recruiting | Sapporo | Japan |
|
| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| D016109 | Epidermolysis Bullosa, Junctional |
| D016108 | Epidermolysis Bullosa Dystrophica |
| D012868 | Skin Abnormalities |
| D003240 | Connective Tissue Diseases |
| D003095 | Collagen Diseases |
| D012871 | Skin Diseases |
| D030342 | Genetic Diseases, Inborn |
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D017437 | Skin and Connective Tissue Diseases |
| D012872 | Skin Diseases, Vesiculobullous |
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