Actively Recruiting
Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome
Led by Quoin Pharmaceuticals · Updated on 2025-04-02
20
Participants Needed
4
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official 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 male or non-pregnant female aged 14 years or older
- Females must be post-menopausal, 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
- 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 for Netherton syndrome prior to baseline
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 evaluation or require conflicting therapies
- Subject has active cancer except non-melanoma skin cancer outside treatment area
- Subject has diabetes except controlled non-insulin dependent diabetes mellitus
- Subject has active infection at screening or serious infection within 30 days before baseline
- Subject has HIV, hepatitis B or C, or active or latent tuberculosis
- Subject used ultraviolet phototherapy in treatment area within 4 weeks before baseline
- Subject used topical prescription treatments in treatment area within 2 weeks before baseline
- Subject used topical bland moisturizers/emollients in treatment area within 24 hours before baseline
- Subject is currently enrolled in another investigational drug, biologic, or device study
- Subject used investigational drugs, biologics, or devices within 30 days before baseline
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
O
Oleg G Khatsenko
CONTACT
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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