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Study Comparing Alitretinoin and Ciclosporin for Patients with Moderate to Very Severe Hand Eczema

Verified siteRegistered drugNo placebo

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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 effectiveness of two medications, alitretinoin and cyclosporine, in treating patients with hand eczema. Hand eczema is a skin condition that causes redness, itching, and sometimes blisters on the hands. The purpose of the study is to compare how well these two medications work in improving the condition of patients with moderate to very severe hand eczema.

Participants in the study will be randomly assigned to receive either alitretinoin or cyclosporine, both of which are taken orally in the form of soft capsules. The study will last for a period of 24 weeks, during which the participants' response to the treatment will be monitored. The main focus will be on the difference in improvement between the two groups from the start of the study to the end of the 24 weeks. Additionally, the study will assess changes in the severity of hand eczema, quality of life, and any side effects experienced by the participants.

Throughout the study, participants will have regular check-ups to evaluate their progress and any changes in their condition. The study aims to provide valuable information on which medication might be more effective for treating hand eczema, potentially leading to better treatment options for patients in the future.

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 study
Upon joining the study, the patient is informed about the trial's objective, which is to compare the effectiveness of two medications, alitretinoin and cyclosporine, in treating moderate to very severe hand eczema.
The patient must meet specific criteria, such as being between 18 and 75 years old and having hand eczema that has not improved with standard treatments.
Step 2
Randomization
The patient is randomly assigned to receive either alitretinoin or cyclosporine. This process ensures that the study results are unbiased.
Step 3
Medication administration
The patient takes the assigned medication orally. The specific dosage and frequency are determined by the study protocol and communicated to the patient at the start of the trial.
The treatment duration is up to 24 weeks, during which the patient is monitored for any changes in their condition.
Step 4
Regular assessments
Throughout the trial, the patient's hand eczema is evaluated at regular intervals using the Physician Global Assessment (PGA) and the Hand Eczema Severity Index (HECSI).
These assessments help track the severity of symptoms and any improvements.
Step 5
Quality of life evaluation
The patient's quality of life is assessed using the Quality Of Life in Hand Eczema Questionnaire (QOLHEQ) at baseline, 12 weeks, and 24 weeks.
This evaluation considers the impact of hand eczema on daily activities and overall well-being.
Step 6
Safety monitoring
The study monitors for any adverse effects of the medications. The patient is required to report any side effects experienced during the trial.
Safety assessments are conducted to ensure the patient's well-being throughout the study.
Step 7
Completion of the trial
At the end of the 24-week period, the patient's response to the treatment is evaluated.
The study aims to determine the difference in treatment effectiveness between the two medications.

Who can join the trial?

8 criteria

Age between 18 and 75 years old.
Have moderate to very severe **hand eczema** for at least 3 months. **Hand eczema** is a skin condition that causes redness, itching, and sometimes blisters on the hands.
Condition must not have improved with standard treatments, which include:
- Using strong creams called **topical corticosteroids** for at least 8 weeks in the last 3 months, with little or no improvement.
- Using regular skin care products like moisturizers and protective creams, without much improvement.
- Avoiding things that irritate the skin or cause allergies, without much improvement.
- Women who can have children must use at least two types of birth control for at least 1 month before starting treatment, during treatment, and for at least 1 month after finishing treatment. They must also take monthly pregnancy tests.
- Able to provide written consent to participate in the study.
- Able to speak and read the Dutch language.

Who cannot join the trial?

3 criteria

Patients who do not have **hand eczema** cannot participate. **Hand eczema** is a skin condition that causes redness, itching, and sometimes blisters on the hands.
Patients who are not within the specified age range cannot participate. The age range for this study is not specified here, but it typically includes adults.
Patients who are part of a vulnerable population cannot participate. A **vulnerable population** includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Verified
Universitair Medisch Centrum Groningen
Groningen, The Netherlands

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Investigated drugs

Alitretinoin
is a medication used in this trial to treat patients with moderate to very severe hand eczema. It is taken orally and works by reducing inflammation and helping to heal the skin. The goal is to see how effective it is in improving the condition of the skin compared to another treatment.
Cyclosporine
is another medication used in the trial for treating moderate to very severe hand eczema. It is also taken orally and works by suppressing the immune system to reduce inflammation and prevent the skin from becoming worse. The trial aims to compare its effectiveness with that of alitretinoin in managing the symptoms of hand eczema.

What is already known about the treatment

Alitretinoin
Alitretinoin is administered orally in the form of capsules. It is currently being studied in clinical trials for its effectiveness in treating moderate to very severe hand eczema. The medication is primarily indicated for chronic hand eczema that does not respond to topical treatments. Alitretinoin works by modulating the immune response and reducing inflammation at the molecular level, acting as a retinoid that influences cell growth and differentiation. It is classified pharmacologically as a retinoid.
Cyclosporine
Cyclosporine is taken orally, usually in capsule or liquid form. It is a well-established medication in the treatment of various autoimmune conditions and is being evaluated for its efficacy in treating moderate to very severe hand eczema. The main therapeutic use of cyclosporine is to suppress the immune system to reduce inflammation and prevent immune-mediated damage. At the molecular level, it inhibits the activity of calcineurin, which is crucial for activating T-cells in the immune system. Cyclosporine is classified as an immunosuppressant.

Investigated diseases

Hand eczema – Hand eczema is a skin condition characterized by inflammation, redness, and itching on the hands. It often presents with symptoms such as dryness, scaling, and sometimes painful cracks or blisters. The condition can be triggered by irritants or allergens, leading to flare-ups that vary in severity. Over time, repeated exposure to triggers can cause the skin to thicken and become more resistant to treatment. The progression of hand eczema can be chronic, with periods of improvement and worsening. It is commonly seen in individuals who frequently wash their hands or handle irritating substances.