Actively Recruiting
A Multicenter, Open-label Study of QRX003 Lotion in Participants With Netherton Syndrome
Led by Quoin Pharmaceuticals · Updated on 2026-04-21
16
Participants Needed
5
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effectiveness of QRX003 lotion at 4% concentration applied twice daily for 12 weeks in people with Netherton Syndrome, a genetic skin condition. This open-label, multicenter study aims to treat affected skin areas covering about 50% or more of the body surface except the scalp. The trial includes children and adults starting from age 4 years. Participants will apply the QRX003 lotion to the treatment areas twice daily for 12 weeks. This investigational treatment is a serine protease inhibitor designed to target the skin issues caused by Netherton Syndrome. The study is open-label, meaning all participants receive the active lotion, and it does not include a placebo group. During the study, participants will be monitored for changes in their skin condition using the Investigator Global Assessment (IGA) scale at week 12, which is the primary outcome. Secondary measures include improvement in itch severity, and patient and clinician global impressions of change. Safety, tolerability, and adherence to the treatment regimen will be assessed. The total participation time aligns with the 12-week treatment period.
CONDITIONS
Brief 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 parental/legal guardian consent if under legal age.
- Female participants must be pre-menarche, postmenopausal, surgically sterile, or use effective birth control during the study and for 3 months after.
- Women of childbearing potential must have negative pregnancy tests at screening and baseline.
- Male participants must use condoms and have partners using effective birth control.
- Participant has a genetically confirmed diagnosis of Netherton Syndrome before baseline or confirmed by genetic testing at screening.
You will not qualify if you...
- Participant is pregnant, breastfeeding, 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 at screening 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 or condition.
- Participant used ultraviolet phototherapy in treatment area within 4 weeks before baseline.
- Participant used systemic non-biologic prescription treatments affecting Netherton Syndrome within 4 weeks before baseline.
- Participant used systemic biologic therapy within 5 half-lives before baseline.
- Participant used topical prescription treatments including steroids in treatment area within 2 weeks before baseline.
- Participant used topical bland moisturizers 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants apply QRX003 lotion twice daily to manage Netherton Syndrome.
Regular visits during treatment as scheduled by the study team
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
O
Oleg G Khatsenko, Ph.D
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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