Recruiting
Phase 2
Phase 3

QRX003

Sponsor:

Quoin Pharmaceuticals

Code:

NCT05789056

Conditions

Netherton Syndrome

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

QRX003, 4% Lotion

Study Details

Brief summary:

To assess the safety, tolerability, and efficacy of QRX003 lotion (4%) when added to standard of care treatment regimen, including systemic therapy in subjects with Netherton syndrome

Conditions

Netherton Syndrome

Study ID

NCT05789056

Start date

Mar 14, 2023

Status verified date

Aug, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

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.
  • Subject is on a stable treatment regimen including systemic therapy for NS prior to baseline that is expected to remain stable for the duration of the study

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 4 weeks prior to Visit 2/Baseline.
  • Subject has used topical prescription treatment in the Treatment Area within 2 weeks prior to Visit 2/Baseline.
  • Subject has used any topical bland moisturizers/emollients in the Treatment Area within 24 hours 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

Enrollment

20 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: QRX003, 4% QAM

Subjects will apply test article once daily in the morning (QAM) for 12 weeks

experimental: QRX003, 4% BID

Subjects will apply test article twice daily (BID) for 12 weeks

Interventions

QRX003, 4% Lotion

QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)

Primary outcome measure

  • Proportion of subjects with 1-point reduction on IGA [ Time Frame: Up to week 16 ]
  • Proportion of subjects with 2-point reduction on IGA [ Time Frame: Up to week 16 ]
  • NS surface area change [ Time Frame: Up to week 16 ]
  • WI-NRS score change [ Time Frame: Up to week 16 ]
  • Assessment of subject satisfaction with treatment based on TSQM [ Time Frame: Up to week 16 ]
  • Proportion of subjects requiring rescue therapy [ Time Frame: Up to week 16 ]
  • Safety Assessment-AEs [ Time Frame: Up to week 16 ]
  • Safety Assessment-LSRs [ Time Frame: Up to week 16 ]

Central Contacts and Locations

Central contacts

TI Clinical Research

858-571-1800clinicalresearch@therapeuticsinc.com

Oleg G Khatsenko

858-571-1800okhatsenko@therapeuticsinc.com

Locations

Site #1

Recruiting

San Diego, California, United States, 92123

Contacts

Oleg G Khatsenko

858-571-1800okhatsenko@therapeuticsinc.com

Site #4

Recruiting

Indianapolis, Indiana, United States, 46250

Contacts

Oleg G Khatsenko

858-571-1800okhatsenko@therapeuticsinc.com

Site #5

Recruiting

Quincy, Massachusetts, United States, 02169

Contacts

Oleg G Khatsenko

858-571-1800okhatsenko@therapeuticsinc.com

More Information

Sponsor

Quoin Pharmaceuticals

Last update posted

Aug 31, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Quoin Pharmaceuticals on 2026-08-31.