What is QRX003 studying for Netherton syndrome?

QRX003 lotion is being studied to assess its safety, tolerability, and effects when added to standard treatments for Netherton syndrome. Researchers aim to understand how this lotion may help improve skin symptoms and patient satisfaction. The study is sponsored by Quoin Pharmaceuticals and involves participants who are already receiving systemic therapy.

Who may be eligible for this Netherton syndrome clinical trial?

People aged 14 years or older with a clinical diagnosis of Netherton syndrome may be eligible. Both males and non-pregnant females can participate, with females required to use effective birth control or be post-menopausal. Participants must be on a stable treatment regimen and in good health otherwise. Please review eligibility criteria for more details.

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

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel or accommodation costs.

Actively Recruiting

Phase 2

Phase 3

Age: 14Years +

All Genders

ID05789056

Study of QRX003 4% Lotion for Treating Netherton Syndrome in Teens and Adults

Led by Quoin Pharmaceuticals · Updated on 2025-04-02

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety, tolerability, and effectiveness of QRX003 lotion 4% when added to the usual treatment for people with Netherton syndrome. This open-label study includes participants who are already receiving systemic therapy and aims to understand how QRX003 lotion may impact their condition over time. The study is sponsored by Quoin Pharmaceuticals and combines phases 2 and 3 to gather comprehensive data. Participants will use QRX003 lotion in one of two ways applying it once daily in the morning or twice daily, both for 12 weeks. The lotion contains a serine protease inhibitor as the active drug. This study does not include a placebo group and is non-randomized, so all participants receive the active treatment. Treatment effects and safety are monitored up to 16 weeks. During the study, participants will have regular assessments to measure changes in their skin condition, including the Investigators Global Assessment IGA score, affected skin surface area, and itch severity using the WI-NRS score. Researchers will also assess participant satisfaction with treatment and track any need for additional rescue therapy. Safety will be monitored by recording adverse events and local skin reactions during the entire 16-week period.

CONDITIONS

Brief Title

Open Label, Safety and Efficacy Study of QRX003 Lotion in Subjects With Netherton Syndrome

Who Can Participate

Age: 14Years +

All Genders

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 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 expected to remain stable throughout the study.

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 study evaluation or require conflicting therapies.
Subject has active cancer except non-melanoma skin cancer outside treatment area.
Subject has diabetes except reasonably controlled non-insulin-dependent diabetes.
Subject has active infection at screening or serious infection within 30 days prior to baseline.
Subject has known HIV, hepatitis B or C, or active/latent tuberculosis.
Subject used ultraviolet phototherapy in treatment area within 4 weeks prior to baseline.
Subject used topical prescription treatment in treatment area within 2 weeks prior to baseline.
Subject used topical bland moisturizers in treatment area within 24 hours prior to baseline.
Subject is currently or recently (within 30 days) enrolled in another investigational drug, biologic, or device study.

Research Team

TI Clinical Research

Oleg G Khatsenko

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Study of QRX003 4% Lotion for Treating Netherton Syndrome in Teens and Adults

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