Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome
NCT ID: NCT05789056
Last Updated: 2025-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2/PHASE3
20 participants
INTERVENTIONAL
2023-03-14
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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QRX003, 4% QAM
Subjects will apply test article once daily in the morning (QAM) for 12 weeks
QRX003, 4% Lotion
QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)
QRX003, 4% BID
Subjects will apply test article twice daily (BID) for 12 weeks
QRX003, 4% Lotion
QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)
Interventions
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QRX003, 4% Lotion
QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
14 Years
ALL
No
Sponsors
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Quoin Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Tony Andrasfay
Role: STUDY_DIRECTOR
Therapeutics, Inc.
Locations
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Site #1
San Diego, California, United States
Site #4
Indianapolis, Indiana, United States
Site #5
Quincy, Massachusetts, United States
Site #2
San Antonio, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CL-QRX003-002
Identifier Type: -
Identifier Source: org_study_id
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