Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome

Part of paid clinical trials in San Diego, California.

Sponsor
Quoin Pharmaceuticals
Study ID
NCT05789056
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Netherton Syndrome

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • QRX003, 4% Lotion — DRUG
    QRX003Topical Lotion containing 4% active drug (serine protease inhibitor)

Study Details

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

Key Dates

Start date
Mar 14, 2023
Status verified
Mar 2025
Primary completion
Dec 30, 2025
Completion
Dec 30, 2025

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

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

Primary Outcome Measure

Proportion of subjects with 1-point reduction on IGA [ Time Frame: Up to week 16 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Site #1San DiegoCalifornia92123
Oleg G Khatsenko
[email protected]
858-571-1800
Site #4IndianapolisIndiana46250
Oleg G Khatsenko
[email protected]
858-571-1800
Site #5QuincyMassachusetts02169
Oleg G Khatsenko
[email protected]
858-571-1800
Site #2San AntonioTexas72218
Oleg G Khatsenko
[email protected]
858-571-1800

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By research site
Site #1· San Diego, CASite #4· Indianapolis, INSite #5· Quincy, MASite #2· San Antonio, TX

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