NCT05521438Phase 2, phase 3Active not recruiting

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

Open ClinicalTrials.gov record CSV export · Pro

Primary completion2025-12-30Actual

Enrollment · participants30Estimated

Source updated2026-03-16Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

Pro unlocks the full available history and CSV export. View Pro features

Posted 2026-03-16 · 2 fields changed

Completion date type changed

− Before

~~Estimated~~

+ After

Actual

Primary completion date changed

− Before

~~31 Dec 2025~~

+ After

30 Dec 2025

Check registry source

Posted 2025-10-28 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

Check registry source

Study details

Conditions studied

Netherton Syndrome

Treatments or interventions studied

QRX003-2% LotionDrug
QRX003-4% Lotion QAMDrug
VehicleDrug
QRX003-4% Lotion BIDDrug

Primary outcomes · main study measures

Read the study measures

measure: Efficacy Endpoints-1-point IGA; description: 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.; timeFrame: Up to week 16; measure: Efficacy Endpoints-2-point IGA; description: Proportion of subjects with 2-point reduction in IGA from Baseline.; timeFrame: Up to week 16; measure: Efficacy Endpoints-NS Sign; description: Change from Baseline in each individual NS Sign (erythema and scaling). Severity of each NS sign is graded on a 5-point scale.; timeFrame: Up to week 16; measure: Efficacy Endpoints-BSA; description: Change from Baseline in total Body Surface Area (BSA) affected by NS in the Treatment Area; timeFrame: Up to week 16; measure: Efficacy Endpoints-WI-NRS score; description: Change from Baseline in the Worst Itch-Numeric Rating Scale (WI-NRS) score. Itch severity is graded on an 11-point scale where 0 represents "no itch" and 10 represents "worst itch imaginable".; timeFrame: Up to week 16; measure: Efficacy Endpoints-TSQM; description: 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.; timeFrame: Up to week 16; measure: Efficacy Endpoints-Rescue Therapy; description: Proportion of subjects requiring rescue therapy; timeFrame: Up to week 16; measure: Safety Endpoints-AEs; description: Any local and systemic AEs (Adverse Events)/serious AEs; timeFrame: Up to week 16; measure: Safety Endpoints-LSR; description: Number of subjects with presence of the following LSRs (Local Skin Reactions): edema, excoriations, oozing/vesiculation/crusting, and erosions at any study visit.; timeFrame: Up to week 16

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

How to read this history