Loading clinical trials...

Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE2/PHASE3

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

A Multicenter, Randomized, Vehicle-Controlled, Double-Blind, Parallel Comparison Study of QRX003 Lotion in Subjects With Netherton Syndrome

NCT05521438•Quoin Pharmaceuticals

View on ClinicalTrials.gov

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

Eligibility

Age

14 - No limit years

Sex

ALL

Healthy Volunteers

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 has NS lesions in the Treatment Area (i.e., arms or lower legs).
•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.

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 Fridericia-corrected QT ≥ 450 ms for males or ≥ 470 ms for females
•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 4 weeks prior to Visit 2/Baseline.
•Subject has used systemic prescription treatment for NS within 4 weeks prior to Visit 2/Baseline.
•Subject has used systemic biologic therapy for NS.
+4 more criteria

Locations (5)

Site #1

San Diego, California, United States

Site #4

Indianapolis, Indiana, United States

Site #5

Quincy, Massachusetts, United States

Site #3

Charleston, South Carolina, United States

Site #2

San Antonio, Texas, United States

Key Dates

Start Date

June 23, 2022

Primary Completion Date

December 30, 2025

Completion Date

December 31, 2026

Last Updated

March 16, 2026

Enrollment

ESTIMATED participants

Conditions

Netherton Syndrome

Interventions

QRX003-2% Lotion

DRUG

QRX003-4% Lotion QAM

DRUG

Vehicle

DRUG

QRX003-4% Lotion BID

DRUG

Study of Skin and Gut Microbiome in a Skin Condition Involving Skin Barrier Impairment and Allergic Symptoms: Netherton Syndrome

NCT07280091

Netherton Syndrome

View study

TERMINATED

Natural History of Netherton Syndrome

NCT05902663

Netherton Syndrome

View study

COMPLETEDPHASE1

A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

NCT01428297

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 16, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Study of Skin and Gut Microbiome in a Skin Condition Involving Skin Barrier Impairment and Allergic Symptoms: Netherton Syndrome

Natural History of Netherton Syndrome

A Study Evaluating the Safety and Efficacy of Topical BPR277 for the Treatment of Atopic Dermatitis and Netherton Syndrome

Clinical Trial Using Humira in Netherton Syndrome