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 @ 6:32 PM
Ignite Modification Date:
2025-12-24 @ 6:32 PM
NCT ID:
NCT06137157
Eligibility Criteria:
Inclusion Criteria:
* Adults ≥18 years of age
* Confirmed mutation of the serine protease inhibitor of Kazal type 5 (SPINK5) gene
* Involvement of ≥20% of body surface area with skin changes consistent with Netherton syndrome
Exclusion Criteria:
* Use of biologic therapies, antibiotics, antihistamines, corticosteroids, retinoids, disease-modifying antirheumatic drugs (DMARDs), immunosuppressive agents, phosphodiesterase-4 (PDE4) inhibitors, topical calcineurin inhibitors, or topical Janus kinase (JAK) inhibitors
* Open wounds or extensive areas of excoriation precluding identification of appropriate application sites in the Investigator's judgment
* Concurrent involvement in any other clinical study/expanded access program with an investigational drug or device or has participated in a clinical study within 30 days prior to the screening visit
* Residing with an immunocompromised person in the same dwelling from the baseline visit through 2 weeks after the treatment period
* History of ultraviolet phototherapy within the planned treatment area 4 weeks prior to baseline
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06137157
Study Brief:
Protocol Section:
NCT06137157