Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Treatment of KeratolytTreatment of Keratolytic Winter Erythema with systemic nitroxoline, a phase 2a randomized placebo controlled crossover study of male and female adults from three Norwegian familiesic Winter Erythema with systemic Nitroxoline, a phase 2a randomized placebo controlled cross-over study of male and female adults from three Norwegian families.

This clinical trial is investigating a new oral medication called Nitroxoline for people with Keratolytic Winter Erythema (KWE). KWE is a skin condition that can cause redness, peeling, and discomfort. The main goal of this study is to find out if Nitroxoline can reduce the size of the areas of skin affected by KWE compared to a dummy pill (placebo). We'll also be looking at whether it helps with other symptoms such as peeling, redness, itchiness, pain, and how it affects daily life. Participants will take Nitroxoline for a period, and then switch to a placebo, or vice versa. The study aims to gather important information on the treatment's effectiveness and safety.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Oslo University Hospital Hf, Oslo University Hospital Hf

Enrolment target

Start

10 Nov 2022

Keratolytic Winter Erythema

What is this study about?

This study is about finding better ways to treat a skin condition called Keratolytic Winter Erythema, often shortened to KWE. KWE causes patches of skin to become red and peel, which can sometimes be uncomfortable or itchy. Currently, there aren't many specific treatments for KWE, so this research is very important for people living with it. We're testing a medicine called Nitroxoline to see if it can help reduce these skin problems.

In this study, we want to see how much Nitroxoline can help improve the affected skin area on your body. Imagine your skin problem gets measured; we'll check if the medicine helps that area shrink or get better. We'll also be looking closely at other things like how much the skin is peeling, how red it is, whether it feels itchy or painful, and if it makes you feel more sensitive to water. We also want to understand if the medicine makes a difference to your daily life and overall well-being.

This is what's called a 'phase 2a' study, which means it's one of the earlier stages of testing a new medicine. It's designed to explore if the treatment works and is safe before it can be offered more widely. Participants will take either the study medicine or a dummy pill (placebo) for a period, and then switch over to the other. This helps us compare the effects of the medicine directly. The study involves adults from specific Norwegian families who experience KWE, helping us understand more about this condition and its potential treatments.

Key takeaways

This study is testing a new medicine, Nitroxoline, for Keratolytic Winter Erythema (KWE).
It aims to see if Nitroxoline reduces affected skin areas and improves symptoms like redness, peeling, or itch.
Participants will take either the study medicine or a dummy pill and will switch between them.
The study lasts about one year and involves regular clinic visits for check-ups and assessments.
The research helps find better treatments for KWE and understand its impact on daily life.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. Both men and women are welcome to participate. The study is specifically looking for participants from three particular families in Norway. This means that if you are from a different family or background, you might not be able to join this specific research.

The research team will carry out some checks to make sure the study is right for you and that taking part would be safe. They will ensure that your health and circumstances match what is needed for the study. It's important that you meet all the specific requirements to ensure the study results are as accurate and helpful as possible.

If you're interested and think you might fit the criteria, you should speak to your doctor or the study team. They can provide more details and help you understand if this study is suitable for you.

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.

Are you 18 years old or older?
Do you have Keratolytic Winter Erythema (KWE)?
Are you male or female?
Are you from one of the three specific Norwegian families participating in the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will first have an initial screening to ensure you meet all the necessary requirements. Once you're in the study, you'll be given capsules to take, which will either be the study medicine (Nitroxoline) or a dummy pill (placebo). Neither you nor the study team will know which you are taking at any given time, but you will take both at different points during the study.

You will have several appointments at the study clinic throughout the year. At these visits, the study team will carry out various assessments. This includes carefully measuring the areas of your skin affected by KWE. They will also check on symptoms like redness, peeling, itching, and pain using special scales. You might also be asked to complete questionnaires about your quality of life, any fatigue you experience, and your mood. Some visits might involve blood tests or a physical examination to monitor your health and safety.

The total duration of your involvement in the study will be about a year (52 weeks). There will be regular check-ups to track your progress and make sure you're doing well. You'll switch from taking the study medicine to the placebo, or vice versa, at a specific point during this period.

Potential risks and benefits

By taking part in this study, you might personally benefit if the Nitroxoline treatment helps to improve your Keratolytic Winter Erythema symptoms, such as reducing the affected skin area or easing discomfort. Even if you don't directly benefit, the information gathered from your participation will be incredibly valuable for improving our understanding of KWE and developing potential new treatments for others in the future. As with any medication, there's always a chance of side effects or risks, which the study team will monitor closely. You will be told about any known risks before you start. Remember, taking part in a clinical trial is always voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

What is Keratolytic Winter Erythema (KWE)?

KWE is a skin condition that causes patches of skin to become red and peel, which can sometimes be uncomfortable or itchy. It often gets worse in winter.

What is Nitroxoline?

Nitroxoline is the medicine being tested in this study. It comes in capsule form, and we're exploring if it can help improve KWE symptoms.

What is a 'placebo'?

A placebo is a 'dummy' pill that looks just like the study medicine but contains no active drug. It helps researchers compare the effects of the real medicine.

How long will I be in the study?

If you join, you'll be involved in the study for about one year (52 weeks), with regular visits for check-ups and assessments.

Can I leave the study if I change my mind?

Yes, taking part is completely voluntary. You can decide to leave the study at any time, for any reason, without it affecting your usual medical care.