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Study on Oral Roflumilast for Treating Chronic Hand Eczema in Adults

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the treatment of chronic hand eczema, a persistent skin condition that causes redness, itching, and inflammation on the hands. The study will use a medication called Roflumilast, which is taken as a film-coated tablet. Roflumilast is a type of medicine known as a PDE4-inhibitor, which works by reducing inflammation in the body. Some participants in the study will receive a placebo, which looks like the real medication but does not contain any active ingredients.

The purpose of the study is to investigate how effective and safe Roflumilast is for adults with chronic hand eczema. Participants will take the medication or placebo orally for a period of up to 28 days. Throughout the study, researchers will monitor the severity of the eczema and any changes in the participants' quality of life. The study will also track any side effects or adverse reactions to the treatment.

Participants will be assessed on various aspects, such as the reduction in eczema severity and improvements in their daily life activities. The study aims to see if Roflumilast can significantly reduce the symptoms of chronic hand eczema and improve the overall well-being of those affected by this condition. The trial is expected to continue until 2028, with the recruitment of participants having started in August 2023.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the trial
Upon joining the trial, you will be assigned to one of two groups. One group will receive the medication roflumilast, and the other group will receive a placebo. A placebo is a substance with no active medication, used to compare the effects of the actual drug.
Step 2
Medication administration
You will take the assigned medication orally. The exact dosage and frequency will be provided by the study team. The treatment will last for a specified period, which will be communicated to you at the start of the trial.
Step 3
Regular assessments
Throughout the trial, you will undergo regular assessments to monitor the severity of your hand eczema. This includes measuring the hand eczema severity index (HECSI), which evaluates the extent and intensity of your condition.
You will also complete questionnaires about your quality of life and any symptoms you experience, such as pain or itchiness.
Step 4
Primary evaluation
The main goal is to see if there is at least a 75% reduction in the severity of your hand eczema after 16 weeks of treatment, compared to when you started the trial.
Step 5
Secondary evaluations
Additional evaluations will look at other levels of improvement, such as 50%, 90%, or even 100% reduction in eczema severity.
Your overall quality of life and satisfaction with the treatment will also be assessed.
Step 6
Monitoring side effects
Any side effects or unexpected reactions will be documented during the trial. This is to ensure your safety and to understand the medication's effects better.
Step 7
End of trial
At the end of the trial, you will have a final assessment to evaluate the overall impact of the treatment on your hand eczema.

Who can join the trial?

7 criteria

Must be between 18 and 75 years old.
Must have a HECSI score of 18 or higher, which indicates moderate to severe hand eczema. HECSI stands for Hand Eczema Severity Index, a way to measure how severe the eczema is.
Must have an IGA-CHE score of 3 or higher. IGA-CHE stands for Investigator's Global Assessment for Chronic Hand Eczema, a scale used to assess the severity of the condition.
Must have a Body Mass Index (BMI) of 20 kg/m² or higher. BMI is a measure of body fat based on height and weight.
Women who can have children must have a negative pregnancy test.
Women who can have children must be willing to use safe contraception during the entire study and for at least 1 week after the end of treatment.
Must be able to speak, understand, and read Danish.

Who cannot join the trial?

3 criteria

Patients who are not adults cannot participate. This means you must be 18 years or older.
Patients who do not have chronic hand eczema cannot participate. Chronic hand eczema is a long-lasting skin condition that affects the hands.
Patients who are part of a vulnerable population cannot participate. This usually refers to groups who may need special protection or care.

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Verified sites

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Bispebjerg Hospital
Verified
Copenhagen, Denmark
Region Midtjylland
Responsive
Aarhus, Denmark
Roskilde University
Responsive
Roskilde, Denmark

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Investigated drugs

Roflumilast is a medication being tested in this trial for its effectiveness and safety in treating chronic hand eczema. It works by reducing inflammation in the body, which can help improve the condition of the skin. Roflumilast is taken orally, meaning it is swallowed in the form of a pill. The goal of using this medication is to see if it can help reduce the symptoms of eczema, such as redness, itching, and swelling, and improve the overall appearance and comfort of the skin on the hands.

What is already known about the treatment

Roflumilast – Roflumilast is administered orally in the form of a tablet. It is currently being studied for its effectiveness and safety in treating chronic hand eczema, a persistent skin condition. The medication works by inhibiting an enzyme called phosphodiesterase-4 (PDE4), which plays a role in inflammation, thereby reducing the symptoms of eczema. Roflumilast is classified as a PDE4 inhibitor, a type of drug that helps control inflammatory responses in the body.

Investigated diseases

Chronic hand eczema – Chronic hand eczema is a persistent inflammatory skin condition affecting the hands. It is characterized by redness, itching, scaling, and sometimes painful cracks or blisters. The condition can vary in severity, ranging from mild to very severe, and often fluctuates over time. It typically progresses with periods of flare-ups and remissions. The skin may become thickened and rough due to repeated inflammation and scratching. Chronic hand eczema can significantly impact daily activities and quality of life due to discomfort and visible skin changes.