Actively Recruiting
Phase 2/3 Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome
Led by Quoin Pharmaceuticals · Updated on 2026-04-21
16
Participants Needed
5
Research Sites
53 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label study to evaluate the safety, tolerability, and efficacy of 4% QRX003 lotion applied twice daily (BID) for 12 weeks to Netherton syndrome (NS) diseased skin in all affected areas of the body excluding the scalp (the Treatment Area), totaling approximately 50% Body Surface Area (BSA) or more.
CONDITIONS
Official Title
Phase 2/3 Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is male or female and at least 4 years of age.
- Participant has provided written informed consent or assent with guardian consent if under legal age.
- Female participants must be premenarche, postmenopausal, surgically sterile, or use effective birth control during and for 3 months after the study.
- Women of childbearing potential must have negative pregnancy tests at screening and baseline.
- Males must use condoms and ensure female partners use effective birth control.
- Participant has a genetically confirmed diagnosis of Netherton syndrome before baseline; genetic testing provided if needed.
You will not qualify if you...
- Participant is pregnant, lactating, or plans to become pregnant during the study.
- Participant has active cancer except melanoma skin cancer outside treatment area.
- Participant has diabetes except well-controlled non-insulin dependent diabetes.
- Participant has active infection or serious infection within 30 days before baseline.
- Participant has known HIV, hepatitis B or C, or active/latent tuberculosis.
- Participant has uncontrolled or significant systemic disease as judged by investigator.
- Participant used ultraviolet phototherapy in treatment area within 4 weeks before baseline.
- Participant used systemic non-biologic prescription treatments for Netherton syndrome within 4 weeks before baseline.
- Participant used systemic biologic therapy for Netherton syndrome within 5 half-lives before baseline.
- Participant used topical prescription treatments in treatment area within 2 weeks before baseline.
- Participant used topical bland moisturizers/emollients in treatment area within 24 hours before baseline.
- Participant is currently enrolled in another investigational drug, biologic, or device study.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Center for Dermatology Clinical Research
Fremont, California, United States, 94538
Actively Recruiting
2
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Not Yet Recruiting
3
Dawes Fretzin Clinical Reseacrh Group
Indianapolis, Indiana, United States, 46250
Actively Recruiting
4
Beacon Clinical Research
Quincy, Massachusetts, United States, 02169
Actively Recruiting
5
Texas Dermatology and Laser Specialists
San Antonio, Texas, United States, 78218
Actively Recruiting
Research Team
T
TI Clinical Research
CONTACT
O
Oleg G Khatsenko, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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