RecruitingNCT06953466Updated Aug 31, 2026

Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome

A Phase 2/3 interventional study of QRX003, 4% Lotion in Netherton Syndrome, sponsored by Quoin Pharmaceuticals. Recruiting at 1 site in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.

Sponsored by Quoin Pharmaceuticals · Phase 2/3, Interventional, and Treatment

From the registry’s dates

Started Oct 2025; still recruiting 1 year later.

Phase: Phase 2/3
Study type: Interventional
Enrollment: 8
Allocation: Not applicable
Ages: 14 Years and older
Sex: All

Study summary

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:

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)?
What medical problems do participants have when taking QRX003?
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.

Conditions studied

Netherton Syndrome

Browse trials for

Netherton Syndrome 21

In context

Netherton Syndrome

21 studies on the registry are indexed under Netherton Syndrome; 6 are open to participants now.

This study's planned enrollment of 8 is below the median of 14 across 18 interventional studies indexed under Netherton Syndrome.

Browse Netherton Syndrome studies →

Lead sponsor

Quoin Pharmaceuticals is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 14 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Subject is a male or non-pregnant female at least 14 years of age.
Females must be post-menopausal , surgically sterile , or use an effective method of birth control , for the duration of the study and for 3 months following completion of treatment. Women of childbearing potential (WOCBP) must have a negative urine pregnancy test (UPT) at Visit 1/Screening and Visit 2/Baseline.
Subject has a clinical diagnosis of NS and agrees to genetic testing at Visit 1/Screening for confirmation of NS diagnosis if the subject does not have test results confirming a SPINK5 mutation.
Subject is in good general health and free of any disease state or physical condition that might impair evaluation of NS or exposes the subject to an unacceptable risk by study participation.
Subject is on a stable treatment regimen including topical therapy for NS prior to baseline that is expected to remain stable for the duration of the study

Exclusion criteria

Exclusion Criteria:

Subject is pregnant, lactating, or is planning to become pregnant during the study.
Subject has any skin pathology in the Treatment Area or condition that, could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area.
Subject has diabetes of any type, except non-insulin dependent diabetes mellitus that is reasonably controlled.
Subject has evidence of active infection during screening, or serious infection within 30 days prior to Visit 2/Baseline.
Subject has known human immunodeficiency virus, hepatitis B or C virus, or active or latent tuberculosis.
Subject has used ultraviolet phototherapy within the Treatment Area within 10 weeks prior to Visit 2/Baseline.
Subject has used topical prescription treatment in the Treatment Area within 10 weeks prior to Visit 2/Baseline.
Subject has used any topical steroid prescription treatments in the Treatment Area within 10 weeks prior to Visit 2/Baseline.
Subject is currently enrolled in an investigational drug, biologic, or device study.
Subject has used an investigational drug, biologic, or device treatment within 30 days prior to Visit 2/Baseline.

Study design

Phase: Phase 2 / Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 8 participants (estimated)

Study arms

Experimental
QRX003, 4% BID
Subjects will apply test article twice daily (BID) for 12 weeks
Drug: QRX003, 4% Lotion

Interventions

DrugQRX003, 4% Lotion
QRX003 Topical Lotion containing 4% active drug (serine protease inhibitor)

What researchers measure

Primary outcomes

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.
Time frame: Up to week 16

Other outcomes

Proportion of subjects with 2-point reduction on IGA
Proportion of subjects with 2-point reduction in IGA from Baseline.
Time frame: Up to week 16
NS surface area change
Change from Baseline in total Body Surface Area (BSA) affected by NS in the Treatment Area
Time frame: Up to week 16
WI-NRS score change
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".
Time frame: Up to week 16
Safety Assessment-AEs
Any local and systemic AEs (Adverse Events)/serious AEs
Time frame: Up to week 16

Study locations

1 of 1 sites recruiting

Northwestern Memorial Hospital
Chicago, Illinois 60611, United States
- Oleg G Khatsenko · Contact · okhatsenko@therapeuticsinc.com · 858-571-1800
Recruiting

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 31, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT06953466
Lead sponsor: Quoin Pharmaceuticals
Responsible party: Sponsor
First posted: May 1, 2025
Start date: Oct 6, 2025
Primary completion: Dec 30, 2026 (estimated)
Completion: Dec 30, 2026 (estimated)
Last update: Aug 31, 2026

Study contacts

TI Clinical Research

Contact

clinicalresearch@therapeuticsinc.com

858-571-1800 ext. 147

Oleg G Khatsenko

Contact

okhatsenko@therapeuticsinc.com

858-571-1800 ext. 166

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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