CACIPLIQ20 in Wound Healing in Subjects With Epidermolysis Bullosa (MATHBULL)
Epidermolysis Bullosa Dystrophica, Epidermolysis Bullosa, Junctional
About this trial
This is an interventional supportive care trial for Epidermolysis Bullosa Dystrophica
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Sites / Locations
- Hopital Necker - enfants malades
Arms of the Study
Arm 1
Arm 2
Other
Other
A: CACIPLIQ20 before placebo
B: placebo before CACIPLIQ20
Arm A will receive at first CACIPLIQ20 (experimental product) for 1 month, followed by 1-month washout, then 1 month of saline (placebo comparator).
Arm B will receive at first saline (placebo comparator) for 1 month, followed by 1-month washout, then 1 month of CACIPLIQ20 (experimental product).