Actively Recruiting
A Multicenter, Open Label Study of QRX003 Lotion in Subjects With Netherton Syndrome
Led by Quoin Pharmaceuticals · Updated on 2025-04-02
20
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of QRX003 lotion (4%) when added to the usual treatment for people with Netherton syndrome. This open-label study includes participants who are already receiving systemic therapy and aims to understand how QRX003 lotion may impact their condition over time. The study is sponsored by Quoin Pharmaceuticals and combines phases 2 and 3 to gather comprehensive data. Participants will use QRX003 lotion in one of two ways: applying it once daily in the morning or twice daily, both for 12 weeks. The lotion contains a serine protease inhibitor as the active drug. This study does not include a placebo group and is non-randomized, so all participants receive the active treatment. Treatment effects and safety are monitored up to 16 weeks. During the study, participants will have regular assessments to measure changes in their skin condition, including the Investigator's Global Assessment (IGA) score, affected skin surface area, and itch severity using the WI-NRS score. Researchers will also assess participant satisfaction with treatment and track any need for additional rescue therapy. Safety will be monitored by recording adverse events and local skin reactions during the entire 16-week period.
CONDITIONS
Brief Title
Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is a male or non-pregnant female at least 14 years of age.
- Females must be post-menopausal, surgically sterile, or use effective birth control during the study and for 3 months after treatment.
- Women of childbearing potential must have a negative pregnancy test at screening and baseline.
- Subject has a clinical diagnosis of Netherton syndrome and agrees to genetic testing if no prior confirmation.
- Subject has Netherton syndrome lesions on arms or lower legs.
- Subject is in good general health without conditions that impair evaluation or increase risk.
- Subject is on a stable treatment regimen including systemic therapy expected to remain stable throughout the study.
You will not qualify if you...
- Subject is pregnant, lactating, or planning pregnancy during the study.
- Subject has skin conditions in the treatment area that interfere with study evaluation or require conflicting therapies.
- Subject has active cancer except non-melanoma skin cancer outside treatment area.
- Subject has diabetes except reasonably controlled non-insulin-dependent diabetes.
- Subject has active infection at screening or serious infection within 30 days prior to baseline.
- Subject has known HIV, hepatitis B or C, or active/latent tuberculosis.
- Subject used ultraviolet phototherapy in treatment area within 4 weeks prior to baseline.
- Subject used topical prescription treatment in treatment area within 2 weeks prior to baseline.
- Subject used topical bland moisturizers in treatment area within 24 hours prior to baseline.
- Subject is currently or recently (within 30 days) enrolled in another investigational drug, biologic, or device study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 weeks
Participants apply QRX003 topical lotion containing 4% active drug once or twice daily to affected areas for 12 weeks.
Daily application visits are not required; treatment is self-administered at home
Trial Site Locations
Total: 4 locations
1
Site #1
San Diego, California, United States, 92123
Actively Recruiting
2
Site #4
Indianapolis, Indiana, United States, 46250
Actively Recruiting
3
Site #5
Quincy, Massachusetts, United States, 02169
Actively Recruiting
4
Site #2
San Antonio, Texas, United States, 72218
Not Yet Recruiting
Research Team
T
TI Clinical Research
O
Oleg G Khatsenko
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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