Study on Treating Keratolytic Winter Erythema in Adults Using Nitroxoline

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What is this study about?

This clinical trial is focused on studying a skin condition called Keratolytic Winter Erythema (KWE). KWE is a rare genetic disorder that causes red, scaly patches on the skin, particularly during the winter months. The study will explore the effectiveness of a treatment using a medication called Nitroxoline, which is an antibiotic taken by mouth. Participants in the study will receive either Nitroxoline or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine how well Nitroxoline works in reducing the total area of skin affected by KWE over a period of 22 weeks. Participants will be adults from three Norwegian families who have been diagnosed with KWE. The study will follow a crossover design, meaning that participants will receive both the Nitroxoline treatment and the placebo at different times during the study. This approach helps to compare the effects of the medication directly with the placebo.

Throughout the study, participants will be monitored for changes in the size and severity of the skin patches, as well as any side effects from the treatment. The study will also assess the impact of the treatment on participants’ quality of life, including factors like pain, itchiness, and overall well-being. The trial is expected to last for a total of 26 weeks, with regular check-ups to track progress and ensure the safety of all participants.

1 beginning of the trial

Upon joining the study, you will be asked to provide signed informed consent. This confirms your understanding of the study requirements and your agreement to participate.

You will undergo a baseline assessment, which includes a physical examination and laboratory tests to establish your current health status.

2 medication administration

You will be randomly assigned to receive either the study medication, nitroxoline, or a placebo. The medication is taken orally in the form of capsules.

The dosage is 250 mg per capsule, and you will take the medication as directed by the study team. The duration of this phase is 22 weeks.

3 regular monitoring

Throughout the study, you will have regular visits to monitor your health and the effects of the medication. These visits will include physical examinations and laboratory tests.

The study team will also assess the area of skin affected by keratolytic winter erythema and any changes in symptoms.

4 crossover phase

After the initial 22-week period, you will switch to the other treatment group. If you were taking nitroxoline, you will now receive the placebo, and vice versa.

This phase also lasts for 22 weeks, and you will continue to take the capsules as directed.

5 final assessments

At the end of the study, you will undergo final assessments, including physical examinations and laboratory tests.

The study team will evaluate the overall effectiveness of the treatment and any changes in your condition.

Who Can Join the Study?

The participant must have a diagnosis of Keratolytic Winter Erythema (KWE). This means they have typical signs of the condition confirmed by genetic testing, either for themselves or a close family member.
The participant must be at least 18 years old.
The participant must weigh at least 50 kilograms (about 110 pounds).
If the participant is a woman who can have children, she must use effective birth control during the entire study.
The participant must be able to give signed informed consent. This means they understand the study and agree to follow the rules and requirements.

Who Cannot Join the Study?

Patients who are not affected by Keratolytic Winter Erythema cannot participate. This is a specific skin condition being studied.
Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
Patients who are part of vulnerable populations cannot participate. This includes groups that may need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Oslo Universitetssykehus HF	Oslo	Norway

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Norway	Not recruiting	02.01.2023

Trial locations

Nitroxoline is a medication being tested in this clinical trial to see if it can help treat a skin condition called Keratolytic Winter Erythema (KWE). This condition affects the skin, causing it to become red, scaly, and sometimes painful, especially in cold weather. The trial aims to find out if taking Nitroxoline by mouth can reduce the total area of skin affected by KWE over a period of 22 weeks. Participants in the study are both men and women from three families in Norway who have this condition. The goal is to determine if Nitroxoline can effectively improve their skin condition and provide relief from the symptoms of KWE.

Investigated diseases:

Erythema

Keratolytic Winter Erythema – Keratolytic Winter Erythema is a rare skin condition characterized by redness and peeling of the skin, primarily affecting the hands and feet. It typically occurs during the colder months, hence the name “winter erythema.” The condition progresses with the development of erythematous patches that may become scaly and peel. The affected areas can be itchy and sometimes painful, leading to discomfort. The severity of symptoms can vary, with some individuals experiencing mild irritation while others have more pronounced skin changes. The condition is often associated with increased sensitivity to water and may be accompanied by excessive sweating.

Trial ID:

2022-501726-38-00

Protocol code:

1.0

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Treating Keratolytic Winter Erythema in Adults Using Nitroxoline

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