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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Serine Protease Inhibitor
Center for Dermatology Clinical Research
Fremont, California, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
NOT_YET_RECRUITINGDawes Fretzin Clinical Reseacrh Group
Indianapolis, Indiana, United States
Proportion of subjects with 1-point reduction on IGA
The IGA (Investigator Global Assessment) is a 5-point scale used to assess the overall severity of a Subject's NS condition.
Time frame: Week 12
Proportion of subjects with 2-point improvement on the WI-NRS
Subjects will rate their itch intensity using the 11-point Worst-Itch-Numeric Rating Scale (WI-NRS)
Time frame: Week 12
PGI-C Score
Patient (or Caregiver) Global Impression of Change (PGI-C) is a 7-point, self-assessed scale measuring the patient's (or caregiver's) improvement of their NS condition.
Time frame: Week 12
CGI-C Score
Clinical Global Impression of Change (PGI-C) is a 7-point scale used by the clinician to assess improvement of the NS condition.
Time frame: Week 12
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Beacon Clinical Research
Quincy, Massachusetts, United States
RECRUITINGTexas Dermatology and Laser Specialists
San Antonio, Texas, United States
RECRUITING