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 @ 7:13 PM
Ignite Modification Date:
2025-12-24 @ 7:13 PM
NCT ID:
NCT06136403
Eligibility Criteria:
Inclusion Criteria:
* Subject has congenital skin fragility with skin and/or mucosal blisters, a clinical phenotype of EBS-sev and a laboratory confirmed diagnosis of EBS by KRT5 and/or 14 mutation (autosomal only) OR a clinical phenotype of inflammatory ichthyosis (IC) including keratinopathic ichthyosis due to KRT1/10 mutation, ECI with identified genetic mutations (TGM5, NIPAL4, ABCA12, etc…).
* Subject has at least a mean daily number of 4 new blisters (EBS-sev) OR an ISS \> 50/128.
* Subject agrees not to use any topical therapies other than the investigator approved.
Exclusion Criteria:
* Subjects with another form of ICI ie Netherton syndrome, Kid syndrome etc.
* Infectious/Immune-related Exclusions
* Medical History and Concurrent Diseases
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT06136403
Study Brief:
Protocol Section:
NCT06136403