NCT05789056Phase 2, phase 3Recruiting

Open Label, Safety and Efficacy Study 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.

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Primary completion2026-12-30Estimated

Enrollment · participants20Estimated

Source updated2026-08-31Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-31 · 1 field changed

Primary completion date changed

− Before

~~30 Dec 2025~~

+ After

30 Dec 2026

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Study details

Conditions studied

Netherton Syndrome

Treatments or interventions studied

QRX003, 4% LotionDrug

Primary outcomes · main study measures

Read the study measures

measure: Proportion of subjects with 1-point reduction on 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: Proportion of subjects with 2-point reduction on IGA; description: Proportion of subjects with 2-point reduction in IGA from Baseline.; timeFrame: Up to week 16; measure: NS surface area change; description: Change from Baseline in total Body Surface Area (BSA) affected by NS in the Treatment Area; timeFrame: Up to week 16; measure: WI-NRS score change; description: Change from Baseline in the Worst Itch-Numeric Rating Scale (WI-NRS) score ≥4. 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: Assessment of subject satisfaction with treatment based on 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: Proportion of subjects requiring rescue therapy; description: Proportion of subjects requiring rescue therapy; timeFrame: Up to week 16; measure: Safety Assessment-AEs; description: Any local and systemic AEs (Adverse Events)/serious AEs; timeFrame: Up to week 16; measure: Safety Assessment-LSRs; 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.

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