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 @ 3:44 AM
Ignite Modification Date:
2025-12-25 @ 3:44 AM
NCT ID:
NCT04214002
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent is provided. Patients 18 years of age and older, and parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide written informed consent prior to participating in the study; additionally, informed assent will be obtained from patients younger than 18 years of age as specified by local requirements.
* Patient must have a documented diagnosis of DEB based on genetic analysis showing a mutation in COL7A1 or, in the opinion of the investigator, a confirmed diagnosis of DEB based on histologic criteria (antigen mapping or electron microscopy).
* Age: 6 months and older
* Patient must have at least 1 wound that is suitable for imaging, in the opinion of the investigator, at the time of enrollment.
* Patient is willing and able to undergo the protocol-specified procedures.
Exclusion Criteria:
* In the opinion of the investigator, inclusion poses an unacceptable risk to the patient or interpretation of these study data.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Months
Study:
NCT04214002
Study Brief:
Protocol Section:
NCT04214002