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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
Females must be post-menopausal, surgically sterile, or use an effective method of birth control for the duration of the study and for 3 months following completion of treatment
Subject has NS lesions in the Treatment Area (i.e., arms or lower legs)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to week 16
Awards & highlights
Study Summary
This trial will study if adding a lotion to standard care can help treat Netherton Syndrome.
Who is the study for?
This trial is for adults with Netherton Syndrome (NS) who are in good health and on a stable NS treatment regimen. Participants must not be pregnant, have active infections, or other skin conditions that could affect the study. Women must use birth control during the study and agree to genetic testing if they haven't confirmed an NS diagnosis.Check my eligibility
What is being tested?
The trial tests QRX003 lotion (4%) combined with standard care for safety, tolerability, and effectiveness in treating NS. It's open-label, meaning everyone knows they're getting the lotion along with their usual systemic therapy.See study design
What are the potential side effects?
While specific side effects of QRX003 aren't listed here, lotions can typically cause skin reactions like redness, itching or burning sensations at the application site. Systemic absorption may lead to broader side effects depending on individual patient responses.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am either post-menopausal, surgically sterile, or I will use effective birth control during and 3 months after the study.
Select...
I have skin lesions on my arms or lower legs.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to week 16
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to week 16
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assessment of subject satisfaction with treatment based on TSQM
NS surface area change
Proportion of subjects requiring rescue therapy
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: QRX003, 4% QAMExperimental Treatment1 Intervention
Subjects will apply test article once daily in the morning (QAM) for 12 weeks
Group II: QRX003, 4% BIDExperimental Treatment1 Intervention
Subjects will apply test article twice daily (BID) for 12 weeks
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Who is running the clinical trial?
Quoin PharmaceuticalsLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Netherton Syndrome
30 Patients Enrolled for Netherton Syndrome
Tony AndrasfayStudy DirectorTherapeutics, Inc.
6 Previous Clinical Trials
542 Total Patients Enrolled
1 Trials studying Netherton Syndrome
30 Patients Enrolled for Netherton Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am at least 18 years old and not pregnant.I am in good health with no conditions that would risk my safety in the study.I have used a basic moisturizer on the treatment area within the last 24 hours.I have active cancer, not including non-melanoma skin cancer, outside the treatment area.I am on a steady treatment plan for my condition that won't change during the study.I have not had a serious infection in the last 30 days.I have used prescription skin treatment in the last 2 weeks.I don't have skin conditions in the treatment area that could affect the study.I have HIV, hepatitis B or C, or tuberculosis.I am either post-menopausal, surgically sterile, or I will use effective birth control during and 3 months after the study.I have diabetes, but it's not the type that's controlled without insulin.I have not used ultraviolet phototherapy in the treatment area in the last 4 weeks.I have a clinical diagnosis of Netherton Syndrome and agree to genetic testing for confirmation.I have skin lesions on my arms or lower legs.I am a woman who can have children and have had negative pregnancy tests.
Research Study Groups:
This trial has the following groups:- Group 1: QRX003, 4% QAM
- Group 2: QRX003, 4% BID
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being accepted for this clinical experiment?
"Affirmative. The clinicaltrials.gov listing for this study reveals that it is currently looking to fill its ranks, having first been posted on March 14th 2023 and last updated on the 16th of March. 10 patients are needed at 2 trial sites."
Answered by AI
Is enrollment open now for this experiment?
"Confirmed. The clinical trials database on clinicaltrials.gov confirms that this trial is actively enrolling participants, having initially been posted on March 14th 2023 and last modified on the 16th of the same month. A total of 10 patients are being sought from two different sites."
Answered by AI
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