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 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 1:20 AM
NCT ID:
NCT04154293
Eligibility Criteria:
Inclusion Criteria:
* Subject is male or female, 9 years of age or older at Visit 2 (Baseline)
* Subject has provided written informed consent
* Females of child bearing potential must be surgically sterile or agree to 2 forms of birth control
* Subject has clinical diagnosis of Congenital Ichthyosis with genetic confirmation of subtype
* Subject has between 10% and 90% total BSA affected by Congenital Ichthyosis
* Subject has at least 2 VIIS assessment areas with a scaling score of 3 or greater
Exclusion Criteria:
* Subject has inflammatory skin diseases unrelated to ichthyosis
* Subject has used other prohibited topical treatments in the assessment areas within certain days from baseline
* Subject has used systemic retinoids within12 weeks of baseline
* Subject has untreated secondary infections
* Subject has lesions suspicious for skin cancer or untreated skin cancers
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Years
Study:
NCT04154293
Study Brief:
Protocol Section:
NCT04154293