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 @ 5:00 PM
Ignite Modification Date:
2025-12-24 @ 5:00 PM
NCT ID:
NCT03445650
Eligibility Criteria:
Inclusion Criteria:
* Subject is aged 3 years or older
* Subject has a genetically-confirmed diagnosis of SLS.
* Subject has active ichthyosis that is Grade 2 or higher on the Visual Index Ichthyosis Severity (VIIS) score.
* Females of child-bearing potential: Negative pregnancy test at Screening and Baseline Visits.
Exclusion Criteria:
* Subject has evidence of a serious active infection.
* Systemic or topical retinoids or other topical medications, not including emollients, within the past 30 days Baseline Visit 1.
* Subject has received an investigational systemic or topically administered drug within the past 30 days prior to Baseline Visit 1.
* Subject is currently receiving immunosuppressive therapy, including intermittent or low-dose systemic corticosteroids.
* Subject has a known allergic reaction to any ingredients of study drug formulation.
* Subject has any clinically significant laboratory test abnormalities or a history of any other condition that, in the opinion of the Investigator, could compromise the subject's ability to comply with the protocol or that could compromise the subject's safety or the interpretation of the study results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
3 Years
Study:
NCT03445650
Study Brief:
Protocol Section:
NCT03445650