Phase 2/3 Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome

Part of paid clinical trials in Fremont, California.

Sponsor
Quoin Pharmaceuticals
Study ID
NCT07538583
Phase
PHASE2/PHASE3
Status
Recruiting

Conditions

  • Netherton Syndrome

Eligibility Criteria

Sex
ALL
Age
4 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QRX003 — DRUG
    Serine Protease Inhibitor

Study Details

This is a multicenter, open-label study to evaluate the safety, tolerability, and efficacy of 4% QRX003 lotion applied twice daily (BID) for 12 weeks to Netherton syndrome (NS) diseased skin in all affected areas of the body excluding the scalp (the Treatment Area), totaling approximately 50% Body Surface Area (BSA) or more.

Key Dates

Start date
Mar 19, 2026
Status verified
Apr 2026
Primary completion
Jan 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
16 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: QRX003 lotion, 4% BID
    Subjects will apply test article twice daily (BID) for 12 weeks

Primary Outcome Measure

Proportion of subjects with 1-point reduction on IGA [ Time Frame: Week 12 ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Center for Dermatology Clinical ResearchFremontCalifornia94538
Oleg Khatsenko, PhD
8585711800
Lisa Duarte
8585711800
Yale University School of MedicineNew HavenConnecticut06520
Oleg Khatsenko, PhD
8585711800
Lisa Duarte
8585711800
Dawes Fretzin Clinical Reseacrh GroupIndianapolisIndiana46250
Oleg Khatsenko, PhD
8585711800
Lisa Duarte
8585711800
Beacon Clinical ResearchQuincyMassachusetts02169
Oleg Khatsenko, PhD
8585711800
Lisa Duarte
858-5711800
Texas Dermatology and Laser SpecialistsSan AntonioTexas78218
Oleg Khatsenko, PhD
8585711800
Lisa Duarte
8585711800

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