A Phase 2/3 interventional study of QRX003, 4% Lotion in Netherton Syndrome, sponsored by Quoin Pharmaceuticals. Recruiting at 4 sites in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Quoin Pharmaceuticals · Phase 2/3, Interventional, and Treatment
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
21 studies on the registry are indexed under Netherton Syndrome; 6 are open to participants now.
This study's planned enrollment of 20 is above the median of 14 across 18 interventional studies indexed under Netherton Syndrome.
Browse Netherton Syndrome studies →Quoin Pharmaceuticals is the lead sponsor of 4 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will apply test article once daily in the morning (QAM) for 12 weeks
Drug: QRX003, 4% Lotion
Subjects will apply test article twice daily (BID) for 12 weeks
Drug: QRX003, 4% Lotion
QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)
Proportion of subjects with 1-point reduction on IGA
Proportion of subjects with 1-point reduction on the Investigator's Global Assessment (IGA) from Baseline. The IGA assesses overall severity of a subject's NS based on a 5-point scale where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
Time frame: Up to week 16
Proportion of subjects with 2-point reduction on IGA
Proportion of subjects with 2-point reduction in IGA from Baseline.
Time frame: Up to week 16
NS surface area change
Change from Baseline in total Body Surface Area (BSA) affected by NS in the Treatment Area
Time frame: Up to week 16
WI-NRS score change
Change from Baseline in the Worst Itch-Numeric Rating Scale (WI-NRS) score ≥4. Itch severity is graded on an 11-point scale where 0 represents "no itch" and 10 represents "worst itch imaginable".
Time frame: Up to week 16
Assessment of subject satisfaction with treatment based on TSQM
Assessment of subject satisfaction with treatment based on the Treatment Satisfaction Questionnaire for Medication (TSQM). The TSQM measures a subject's level of satisfaction or dissatisfaction with the treatment. Composite scores can range from 0 to 100; higher scores indicate better satisfaction.
Time frame: Up to week 16
Proportion of subjects requiring rescue therapy
Proportion of subjects requiring rescue therapy
Time frame: Up to week 16
Safety Assessment-AEs
Any local and systemic AEs (Adverse Events)/serious AEs
Time frame: Up to week 16
Safety Assessment-LSRs
Number of subjects with presence of the following LSRs (Local Skin Reactions): edema, excoriations, oozing/vesiculation/crusting, and erosions at any study visit.
Time frame: Up to week 16
Plan to share: No
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Quoin Pharmaceuticals