What is QRX003 studying for Netherton Syndrome?

QRX003 is being studied to assess its safety, tolerability, and effects on skin symptoms in people with Netherton Syndrome. Researchers want to understand how this lotion works when applied twice daily for 12 weeks. The study is sponsored by Quoin Pharmaceuticals and aims to improve treatment options for this rare skin condition.

Who may be eligible for this Netherton Syndrome clinical trial?

Participants must be at least 4 years old with a confirmed genetic diagnosis of Netherton Syndrome. Both males and females can join, but females must meet specific pregnancy-related criteria. People with certain infections, cancer, or recent use of some skin treatments may not be eligible. Please review eligibility criteria for more details.

Is there any cost to participate in this Netherton Syndrome clinical trial?

Study-related care, including the QRX003 lotion and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should consider these factors when deciding to join.

Actively Recruiting

Phase 2

Phase 3

Age: 4Years +

All Genders

ID07538583

Open-label Study of Twice-Daily QRX003 Lotion for Treating Netherton Syndrome in Participants Aged 4 and Older

Led by Quoin Pharmaceuticals · Updated on 2026-04-21

Participants Needed

Research Sites

8 weeks

Total Duration

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

Age: 4Years +

All Genders

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.

Research Team

TI Clinical Research

Oleg G Khatsenko, Ph.D

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here

Open-label Study of Twice-Daily QRX003 Lotion for Treating Netherton Syndrome in Participants Aged 4 and Older

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria