Phase 2/3 Clinical Study of QRX003 Lotion in Subjects With Netherton Syndrome
This research study is looking at a new skin lotion called QRX003 for people who have a rare skin condition called Netherton Syndrome. The main goal is to find out if this lotion is safe to use, how well people tolerate it, and if it helps to make the skin better. Participants will apply the lotion twice a day for 12 weeks to the parts of their body where the skin is affected, but not on their scalp. The study is open to both males and females aged 4 years and older. It's a key step to understand if QRX003 could be a helpful treatment for Netherton Syndrome in the future.
At a glance
What is this study about?
This study is about a new lotion, called QRX003, designed to help people with a rare skin condition called Netherton Syndrome. Netherton Syndrome makes the skin very red, scaly, and itchy, and it can be quite uncomfortable. Doctors and researchers are always looking for better ways to manage this condition, and this study is a step in that direction.
The main aim of the study is to see if QRX003 lotion is safe to use and if it can help improve the skin affected by Netherton Syndrome. They also want to understand if it causes any side effects and how well people tolerate it. The lotion will be applied directly to the skin, twice a day for a period of 12 weeks.
This is a 'Phase 2/3' study, which means it’s quite advanced. It's designed to gather more information about the lotion's safety and effectiveness in a larger group of people, after earlier tests suggested it might be helpful. The findings from this study will help decide if QRX003 could become a widely available treatment in the future.
Key takeaways
- This study tests a new lotion (QRX003) for Netherton Syndrome.
- It aims to check safety and if it helps improve affected skin.
- Participants apply lotion twice daily for 12 weeks.
- It's for people aged 4 and over with a confirmed diagnosis.
- Regular clinic visits are needed for monitoring.
- Participation is voluntary, and you can withdraw anytime.
Who may be eligible?
To join this study, you or your child must: * Be at least 4 years old. * Have Netherton Syndrome, which has been confirmed by a genetic test (a test that looks at your genes). If you haven't had this test, the study can arrange for one at the start. * Be able to follow all study instructions and attend appointments.
There are also some reasons why someone might not be able to join, or 'exclusion criteria'. For example, you cannot take part if you: * Are pregnant, breastfeeding, or planning to become pregnant during the study. * Have certain other serious medical conditions like active cancer (outside of melanoma skin cancer in unaffected areas), uncontrolled diabetes, or an active infection. * Have known HIV, hepatitis B or C, or active tuberculosis.
Women who could become pregnant will need to use effective birth control throughout the study and for 3 months afterwards. Men whose partners could become pregnant will also need to use condoms, and their partners should use effective birth control.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Am I, or my child, at least 4 years old?
- Do I have a confirmed diagnosis of Netherton Syndrome?
- Am I, or my child, NOT pregnant or breastfeeding?
- Do I NOT have an active serious infection?
- Can I commit to applying the lotion twice daily for 12 weeks?
- Can I attend regular clinic visits?
What does participation involve?
If you decide to take part, you will first have a screening visit to check if you are suitable for the study. If you are, you will then receive the QRX003 lotion.
* **Medication:** You will apply the QRX003 lotion to your affected skin (but not your scalp) twice a day, every day, for 12 weeks. The lotion should cover at least half of your body surface area that is affected. * **Assessments:** Throughout the study, you'll have regular check-ups with the study team. They will carefully monitor your skin to see if it's improving and check for any side effects. These assessments might include physical exams, skin checks, and perhaps blood or urine tests. * **Visits:** You will need to attend several visits at the study clinic over the 12-week period. The exact number and timing of these visits will be explained to you in detail by the study team. * **Total Duration:** Your active participation in applying the lotion and attending visits will last for 12 weeks. There may be some follow-up after this period.
Potential risks and benefits
Locations (8)
- Center for Dermatology Clinical ResearchVerified postcodeFremont, United States· Recruiting
- Yale University School of MedicineVerified postcodeNew Haven, United States· Not yet recruiting
- Dawes Fretzin Clinical Reseacrh GroupVerified postcodeIndianapolis, United States· Recruiting
- Beacon Clinical ResearchVerified postcodeQuincy, United States· Recruiting
- Texas Dermatology and Laser SpecialistsVerified postcodeSan Antonio, United States· Recruiting
- Great Ormond Street Hospital, NIHR - Clinical ResearchVerified postcodeLondon, United Kingdom· Recruiting
- Walsall Manor Hospital, Research & DevelopmentVerified postcodeWalsall, United Kingdom· Recruiting
- Guy's Hospital, Skin Therapy Research UnitVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is Netherton Syndrome?
Netherton Syndrome is a rare genetic skin condition that causes red, scaly, and itchy skin all over the body, along with other symptoms.
What is QRX003 lotion?
QRX003 is a new investigational lotion being tested to see if it can help improve the skin of people with Netherton Syndrome.
How long will I use the lotion?
You will apply the QRX003 lotion twice a day for a total of 12 weeks.
Will I get paid to take part?
The study will cover travel costs to appointments, but you usually won't be paid for your time.
Can I stop taking part if I want to?
Yes, you are free to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
TI Clinical Research
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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