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:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT06713434
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of Recessive Dystrophic and Junctional Epidermolysis bullosa
* Frequent history of corneal abrasions (one or more abrasions every 3 months)
* Age: older than 2 years at the time of joining the clinical trial
* Patients and/or parent/legal guardian has given written informed consent in writing
Exclusion Criteria:
* Acute eye infection at time of enrollment
* Patients with severe vision loss (\<20/200) or severe corneal opacification.
* Contact lens wear or nocturnal eye ointment
* Hypersensitivity to fluorescein (ocular stain used in slit lamp study)
* History of alcohol abuse or drug addiction
* Patient who reports difficulty to attend the 4 in-person controls
* Patients who are suffering from cancer
* Patients with any medical condition or situation which in the opinion of the investigators could put the patient at risk, or could interfere with the patient's participation in the study
* Pregnant or breastfeeding women (a pregnancy test will be performed using a urine sample for female patients who have had menarche).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Study:
NCT06713434
Study Brief:
Protocol Section:
NCT06713434