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Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 30, 2026 → Dec 30, 2026
See other at-risk trials from Quoin Pharmaceuticals

Record History

  1. Primary and study completion pushed from Jul 30, 2026 to Dec 30, 2026
    • Start date changed from estimate of Jul 2025 to Oct 6, 2025
    v3
  2. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Apr 30, 2026 to Jul 30, 2026
    • Start date: Jun 30, 2025 to Jul 2025
    • Site details revised
    v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial (via an expanded access Treatment Protocol) is to learn if QRX003 (an investigational drug) applied topically to the skin (including up to the entire body \[except the scalp\]) works to treat the genetic disease Netherton syndrome. It will also learn about the safety of QRX003. The main questions the trial aims to answer are: 1. Does QRX003 impact the clinical presentation of NS in adults and minors by improving the clinical symptoms (diseased skin area, itch, and discomfort; based on clinical scoring, subject self-assessment, and other criteria)? 2. What medical problems do participants have when taking QRX003? 3. What percent of subjects will require rescue therapy? Participants will: Take drug QRX003 twice daily (applied topically to all affected areas of the body excluding the scalp) for 3 months, visit the clinic once every 4-6 weeks for checkups and tests, and to keep a dosing diary that records the times they applied the drug.
Trial Details
NCT Number NCT06953466
Lead Sponsor Quoin Pharmaceuticals
Conditions
(from sponsor)		 Netherton Syndrome
Related terms Netherton Syndrome
Enrollment 8 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov