Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome
ConditionNetherton Syndrome
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age14+
SponsorQuoin Pharmaceuticals
About this trial
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
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- QRX003, 4% Lotion
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov