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NCT05521438 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Netherton Syndrome, sponsored by Quoin Pharmaceuticals.

Active
Registry status
Phase 2
Development phase
30
Enrollment target
5
Study locations

NCT05521438: Active Phase 2 study of Netherton Syndrome, sponsored by Quoin Pharmaceuticals.

NCT05521438 is a Phase 2 study of Netherton Syndrome that is active but no longer recruiting, run by Quoin Pharmaceuticals. The registered enrollment target is 30 participants, above the 24-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (25% higher). The trial reports 5 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05521438, a Phase 2 study of Netherton Syndrome, is active but no longer recruiting, sponsored by Quoin Pharmaceuticals.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
30 participants
Enrollment target
5
Study locations

Study 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

Primary Outcome

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.

Conditions Studied

Interventions

  • DRUG Vehicle
  • DRUG QRX003-2% Lotion
  • DRUG QRX003-4% Lotion QAM
  • DRUG QRX003-4% Lotion BID

Study Locations (5)

California

  • Site #1 - San Diego

Indiana

  • Site #4 - Indianapolis

Massachusetts

  • Site #5 - Quincy

South Carolina

  • Site #3 - Charleston

Texas

  • Site #2 - San Antonio

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-06-23
Est. Completion 2026-12-31
Phase Phase 2
Quoin Pharmaceuticals

4 total trials

What the registry record for NCT05521438 still lists

NCT05521438 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, above the 24-participant average among 6 other Netherton Syndrome trials with a reported enrollment target (25% higher).

The record links to 1 condition, with Netherton Syndrome appearing as the primary indexed condition, and to 4 interventions - of which Vehicle is the first listed.

NCT05521438 lists 5 locations in 5 states (California, Indiana, Massachusetts).

Frequently Asked Questions

What is clinical trial NCT05521438 about?

NCT05521438 is a clinical study titled "Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome". 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

What is the current status of trial NCT05521438?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-06-23. Estimated completion is 2026-12-31.

What conditions does trial NCT05521438 study?

This clinical trial studies the following conditions: Netherton Syndrome.

What interventions are being tested in trial NCT05521438?

The interventions under investigation include: Vehicle (DRUG), QRX003-2% Lotion (DRUG), QRX003-4% Lotion QAM (DRUG), QRX003-4% Lotion BID (DRUG).

Who is sponsoring clinical trial NCT05521438?

This trial is sponsored by Quoin Pharmaceuticals, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05521438 being conducted?

This trial has 5 study locations across California, Indiana, Massachusetts, South Carolina, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Netherton Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

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Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

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Source: ClinicalTrials.gov NCT05521438, the US trial registry maintained by the National Library of Medicine. NCT05521438 (small enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.