RecruitingNetherton Syndrome
Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome
Eligible age
14+ yrs
Accepts
All genders
Locations
4 states
Healthy volunteers
No
See if you qualify for this study
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About this study
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
Sponsor: Quoin Pharmaceuticals
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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.
Where it's recruiting
Source: ClinicalTrials.gov · NCT05789056 · last updated 2025-04-02