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Topical Agent

QRX003 Lotion for Netherton Syndrome

Phase 2 & 3
Recruiting
Research Sponsored by Quoin Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has NS lesions in the Treatment Area (i.e., arms or lower legs).
Subject is a male or non-pregnant female at least 18 years of age.
Must not have
Subject has active cancer of any type excluding non-melanoma skin cancer outside of the Treatment Area.
Subject has any skin pathology in the Treatment Area or condition that could interfere with the evaluation of the test article or requires use of interfering topical, systemic, or surgical therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 16
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a medicated cream called QRX003 lotion on patients with Netherton Syndrome, a rare skin disorder. The study will check if different doses and application schedules of the lotion are safe and effective. The goal is to see if the lotion can improve skin symptoms like redness and irritation.

Who is the study for?
Adults with Netherton Syndrome (NS) who are in good health and have NS lesions on their arms or lower legs can join this trial. Women must not be pregnant, should use birth control, and have a negative pregnancy test. Participants shouldn't have used certain treatments for NS or any investigational drugs recently.
What is being tested?
The study is testing QRX003 lotion at two different strengths (2% and 4%) against a placebo lotion to see if they're safe, tolerable, and effective for treating Netherton Syndrome.
What are the potential side effects?
While the side effects of QRX003 lotions aren't detailed here, typical topical treatment risks include skin irritation, redness, itching or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have skin lesions on my arms or lower legs.
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I am at least 18 years old and not pregnant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have active cancer, not including non-melanoma skin cancer, outside the treatment area.
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I have a skin condition in the treatment area that could affect the study's results.
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I have used prescription skin treatment recently.
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I have HIV, hepatitis B or C, or tuberculosis.
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I have used systemic biologic therapy for my condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 16
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 16 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy Endpoints-1-point IGA
Efficacy Endpoints-2-point IGA
Efficacy Endpoints-BSA
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups
Experimental Treatment
Group I: Vehicle LotionExperimental Treatment1 Intervention
Subjects will apply test article once daily in the morning (QAM) for 12 weeks
Group II: QRX003-4% QAMExperimental Treatment1 Intervention
Subjects will apply test article once daily in the morning (QAM) for 12 weeks
Group III: QRX003-4% BIDExperimental Treatment1 Intervention
Subjects will apply test article twice daily BID for 12 weeks
Group IV: QRX003-2% QAMExperimental Treatment1 Intervention
Subjects will apply test article once daily in the morning (QAM) for 12 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vehicle
2013
Completed Phase 3
~5070

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Netherton Syndrome is a genetic disorder that affects the skin barrier, leading to chronic skin inflammation and increased susceptibility to infections. Treatments like QRX003 lotion, which is being studied for its efficacy and safety, typically contain active ingredients that aim to restore the skin barrier and reduce inflammation. These treatments often include keratolytic agents, which help to remove the thickened outer layer of the skin, and anti-inflammatory agents that reduce the chronic inflammation characteristic of the condition. Restoring the skin barrier is crucial for Netherton Syndrome patients as it helps to prevent infections, reduce inflammation, and improve overall skin health, thereby enhancing the quality of life.
Systemic glucocorticosteroid therapy of skin disease in children.A systematic review of clinical trials of treatments for the congenital ichthyoses, excluding ichthyosis vulgaris.

Find a Location

Who is running the clinical trial?

Quoin PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
20 Total Patients Enrolled
1 Trials studying Netherton Syndrome
20 Patients Enrolled for Netherton Syndrome
Tony AndrasfayStudy DirectorTherapeutics, Inc.
6 Previous Clinical Trials
532 Total Patients Enrolled
1 Trials studying Netherton Syndrome
20 Patients Enrolled for Netherton Syndrome
~3 spots leftby Jan 2025
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