Actively Recruiting

Phase 3
Age: 21Days +
All Genders
NCT06917690

A Study to Learn About the Safety and Efficacy of the Drug 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

228 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 21Days +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Male or female aged 21 days or older
  • Confirmed diagnosis of junctional EB or dystrophic EB
  • Both biological parents and all four grandparents are of Japanese descent
  • At least three EB wounds located outside the anogenital region, each separated by at least 5 cm
  • At least one wound present for 21 days to less than 9 months and sized 10 cm2 to 50 cm2
  • At least two wounds present for 21 days to less than 9 months and/or sized 10 cm2 to 50 cm2
  • Female participants of childbearing potential must have a negative pregnancy test and agree to use highly reliable contraception during the study
  • Female participants of non-childbearing potential include those pre-menarche, post-menopausal for 12 months without alternative cause, or permanently sterile
  • Participant or legal representative has given written informed consent
  • Participant or legal representative is able and willing to follow all study procedures
Not Eligible

You will not qualify if you...

  • Allergic reaction to Oleogel-S10 or its ingredients
  • Diagnosis of EB simplex or Kindler EB
  • 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 (except certain inhaled or mucosal steroids)
  • Use of immunosuppressive therapy or chemotherapy within 60 days before enrollment (stable dupilumab allowed if over 3 months)
  • Use of systemic gene therapy for inherited EB
  • Use of short-acting stem cell therapy 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 cancer including skin cancers
  • Pregnant, breastfeeding, or unwilling to use reliable contraception if of childbearing potential
  • Participation in other interventional studies or investigational drug treatment within 4 weeks before enrollment
  • Any factor interfering with study compliance such as inability to attend visits or manage dressings at home

AI-Screening

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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

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Research Team

C

Chiesi Clinical Trials

CONTACT

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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