Actively Recruiting
A Single Center, Open Label, Expanded Access Study of QRX003 Lotion in Subjects With Netherton Syndrome
Led by Quoin Pharmaceuticals · Updated on 2025-07-20
8
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether QRX003, an investigational topical lotion, can help treat Netherton syndrome, a genetic skin condition, in both adults and minors aged 14 years and older. The trial also aims to understand the safety of QRX003 and how it affects symptoms like diseased skin area, itching, and discomfort through clinical scores and patient self-assessments. This is an open-label expanded access study sponsored by Quoin Pharmaceuticals. Participants will apply QRX003 lotion containing 4% active drug twice daily to all affected skin areas except the scalp for a period of 12 weeks. The study involves only one treatment group receiving QRX003, with no placebo or comparator. The lotion is applied topically, and the participant follows a stable treatment regimen prior to starting the study. Participants will visit the clinic every 4 to 6 weeks during the 3-month treatment to undergo checkups and tests. They will keep a dosing diary to record each application of the lotion. The main outcome measured is the proportion of subjects who achieve at least a 1-point improvement on the Investigator's Global Assessment (IGA) scale by week 16. Safety monitoring and assessment of any need for rescue therapy are also part of the study. Total participation duration is approximately 3 months.
CONDITIONS
Brief Title
Clinical 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 is in good general health without conditions that impair evaluation or increase risk.
- Subject is on a stable treatment regimen for Netherton syndrome expected to remain unchanged during the study.
You will not qualify if you...
- Subject is pregnant, breastfeeding, or planning pregnancy during the study.
- Subject has skin conditions in the treatment area that interfere with evaluation or require interfering therapies.
- Subject has active cancer (except certain non-melanoma skin cancers outside the treatment area).
- Subject has diabetes except well-controlled non-insulin dependent diabetes.
- Subject has active or recent serious infection.
- Subject has known HIV, hepatitis B or C, or active/latent tuberculosis.
- Subject used ultraviolet phototherapy or topical prescription treatments in the treatment area within 10 weeks before baseline.
- Subject used topical steroid prescription treatments in the treatment area within 10 weeks before baseline.
- Subject is currently or recently 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 4% lotion twice daily to the affected area for 12 weeks.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
T
TI Clinical Research
O
Oleg G Khatsenko
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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