Status:
RECRUITING
CACIPLIQ20 in Wound Healing in Subjects With Epidermolysis Bullosa
Lead Sponsor:
Organ, Tissue, Regeneration, Repair and Replacement
Collaborating Sponsors:
Euraxi Pharma
ARANZ Medical
Conditions:
Epidermolysis Bullosa Dystrophica
Epidermolysis Bullosa, Junctional
Eligibility:
All Genders
3-18 years
Phase:
NA
Brief Summary
Epidermolysis bullosa (EB) is a group of inherited disorders characterized by fragility of the skin and mucous membranes within the basement membrane zone. It is characterized by moderate to excessive...
Detailed Description
The patients are outpatients at inclusion and may be already followed by the investigators, and they have not yet been treated with CACIPLIQ20 for at least one month. These patients will be randomly ...
Eligibility Criteria
Inclusion
- Diagnosis of Dystrophic or Junctional EB.
- 3 years ≤ age ≤ 18 years
- At least one active wound at inclusion
- Informed consent form signed by the patient's legal representative; if the patient is minor but capable of providing consent, additional signed consent from the patient.
- Patient and caregiver must be willing to comply with all protocol requirements.
Exclusion
- Use of any investigational drug within the last 30 days before enrolment.
- Current or former malignancy.
- Pregnancy or breastfeeding during the study.
- Females of childbearing potential who are not abstinent and not practicing a medically acceptable method of contraception.
- Use of CACIPLIQ20 within the last 30 days before enrolment.
- Patients intolerant to one of the study device components or to heparinoids.
Key Trial Info
Start Date :
January 29 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT06007235
Start Date
January 29 2024
End Date
September 1 2024
Last Update
February 13 2024
Active Locations (1)
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1
Hopital Necker - enfants malades
Paris, France, 75000