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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 16

Awards & highlights

Study Summary

This trial is studying if QRX003 lotion is safe and effective for people with Netherton Syndrome.

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.Check my eligibility

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.See study design

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

Select...

I have skin lesions on my arms or lower legs.

Select...

I am at least 18 years old and not pregnant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 16

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy Endpoints-1-point IGA

Efficacy Endpoints-2-point IGA

Efficacy Endpoints-BSA

+6 more

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

0 / 2Eligibility criteria met

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are we actively recruiting subjects for this investigation?

"Yes, this trial is still open for patient recruitment according to the most recent information on clinicaltrials.gov. The posting date was June 23rd, 2022 and the last edit was on August 26th, 2022. There are 18 spots available at 2 research centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome

2022. "Safety, Tolerability and Efficacy of QRX003 Lotion in Subjects With Netherton Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05521438.