A Multicenter, Open Label Study of QRX003 Lotion in Subjects With Netherton Syndrome
Quoin Pharmaceuticals
Summary
To assess the safety, tolerability, and efficacy of QRX003 lotion (4%) when added to standard of care treatment regimen, including systemic therapy in subjects with Netherton syndrome
Eligibility
- Age range
- 14+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Subject is a male or non-pregnant female at least 14 years of age. * Females must be post-menopausal , surgically sterile , or use an effective method of birth control , for the duration of the study and for 3 months following completion of treatment. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline. * Subject has a clinical diagnosis of NS and agrees to genetic testing at Visit 1/Screening for confirmation of NS diagnosis if the subject does not have test results confirming a SPINK5 mutatio…
Interventions
- DrugQRX003, 4% Lotion
QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)
Locations (4)
- Site #1San Diego, California
- Site #4Indianapolis, Indiana
- Site #5Quincy, Massachusetts
- Site #2San Antonio, Texas