Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT06007235
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Maximum Age:
18 Years
Study:
NCT06007235
Study Brief:
Protocol Section:
NCT06007235