NCT05521438

Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome

A Multicenter, Randomized, Vehicle-Controlled, Double-Blind, Parallel Comparison Study of QRX003 Lotion in Subjects With Netherton Syndrome

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Quoin Pharmaceuticals · Industry
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

Summary

This study has been designed to determine the safety, tolerability and efficacy of QRX003 lotion 2%, 4% QAM or 4% BID in subjects with Netherton Syndrome (NS) in comparison to vehicle

Conditions

• Netherton Syndrome

Interventions

Type	Name	Description
DRUG	QRX003-2% Lotion	QRX003Topical Lotion containing 2% active drug (serine protease inhibitor)
DRUG	QRX003-4% Lotion QAM	QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)
DRUG	Vehicle	Vehicle Lotion
DRUG	QRX003-4% Lotion BID	QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)

Timeline

• Start date: 2022-06-23
• Primary completion: 2025-12-30
• Completion: 2026-12-31
• First posted: 2022-08-30
• Last updated: 2026-03-16

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study