Actively Recruiting
Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
Led by Chiesi Farmaceutici S.p.A. · Updated on 2025-12-22
6
Participants Needed
6
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Oleogel-S10 gel in treating skin wounds caused by two inherited forms of epidermolysis bullosa (EB), called junctional EB (JEB) and dystrophic EB (DEB), specifically in the Japanese population. This trial aims to find out if Oleogel-S10 gel can close wounds or reduce their size within 45 days, assess its safety, and measure how much of the gel enters the bloodstream. Both children and adults are invited to join this study. Participants apply Oleogel-S10 gel to their EB wound dressings at least once every four days for 45 days in Part 1 of the study. They visit the clinic every two weeks for checkups and tests during this period. Those who complete Part 1 may choose to continue in Part 2, where they keep receiving Oleogel-S10 gel until it becomes available for purchase in Japan or until the study is stopped by the company. During the study, participants will have regular clinic visits for examinations and tests to monitor wound healing, safety, and drug exposure. Researchers will evaluate the gel's effect on wounds up to 45 days in Part 1 and up to 90 days in Part 2. Safety and tolerability will be assessed throughout the study, which may continue until 2029. Participants will be supervised closely and asked to follow all study instructions and procedures.
CONDITIONS
Brief Title
A Study to Learn About the Safety and Efficacy of the Drug Oleogel-S10 in Japanese Patients With Epidermolysis Bullosa
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 21 days or older
- Confirmed diagnosis of junctional or dystrophic epidermolysis bullosa (EB)
- Both biological parents and all four grandparents are of Japanese descent
- At least three EB wounds located outside the anogenital region, separated by at least 5 cm
- At least one wound present for 21 days to less than 9 months and sized 10 to 50 cm²
- At least two wounds present for 21 days to less than 9 months and/or sized 10 to 50 cm²
- Females of childbearing potential must have negative pregnancy tests and use reliable contraception during the study
- Females of non-childbearing potential (pre-menarche, post-menopausal, or permanently sterile) qualify
- Subject or legal representative has given written informed consent
- Subject or legal representative is able and willing to follow all study procedures and instructions
You will not qualify if you...
- Hypersensitivity to Oleogel-S10 or its ingredients
- Diagnosis of EB simplex or Kindler EB subtypes
- Use of systemic antibiotics for wound infections within 7 days before enrollment
- Use of systemic or topical steroids on EB wounds within 30 days before enrollment (with some exceptions)
- Use of immunosuppressive therapy or cytotoxic chemotherapy within 60 days before enrollment
- Use of systemic gene therapy for inherited EB
- Use of short-acting stem cell therapies within 6 months before enrollment
- Use of topical gene therapy for inherited EB within 3 months before enrollment
- Receipt of JACE® skin graft on any target wounds
- Current or past malignancy, including skin cancers
- Females who are pregnant, lactating, or unwilling to use reliable contraception
- Participation in other interventional studies or use of investigational drugs within 4 weeks before enrollment
- Any factors interfering with study compliance, including ability to attend visits or manage dressings at home
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 90 days
Participants receive the drug Oleogel-S10 as a topical gel to evaluate its safety and efficacy.
Multiple visits during treatment period
Duration - Up to study completion in 2029
Participants are monitored for safety and tolerability after treatment completion.
Visits as scheduled through study completion
Trial Site Locations
Total: 6 locations
1
Fukuoka Children's Hospital - Dermatology
Fukuoka, Japan
Actively Recruiting
2
Kurume University Hospital
Fukuoka, Japan
Actively Recruiting
3
Kobe University Hospital
Kobe, Japan
Actively Recruiting
4
Niigata University Medical and Dental Hospital
Niigata, Japan
Actively Recruiting
5
Toho University Omori Medical Center
Ōta-ku, Japan
Actively Recruiting
6
Hokkaido University Hospital
Sapporo, Japan
Actively Recruiting
Research Team
C
Chiesi Clinical Trials
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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