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 @ 5:25 PM
Ignite Modification Date:
2025-12-24 @ 5:25 PM
NCT ID:
NCT05944250
Eligibility Criteria:
Inclusion Criteria:
* Clinical and/or genetic diagnosis of RDEB by a dermatologist
* Age 6 years or older willing and able to give consent/assent
* At least 6 wounds (3 wound pairs) each with an area of 10cm2 or greater located at any site (excluding face and genital skin)
* Wounds must be present for at least 4 weeks and able to be classified as recurrent wounds (wounds that heal within 12 weeks but then re-blister) vs chronic open (older than 12 weeks)
Exclusion Criteria:
* Actively infected wounds with pus (colonized wounds are eligible)
* Wounds that have had squamous cell carcinoma (SCC)
* Wounds on the face and genitals
* Wounds that have been treated with investigational therapies in the past 3 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
65 Years
Study:
NCT05944250
Study Brief:
Protocol Section:
NCT05944250