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Study on the Effectiveness and Safety of Ruxolitinib Cream for Adults with Chronic Hand Eczema

Verified siteInvestigational

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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 Chronic Hand Eczema, a condition where the skin on the hands becomes inflamed, itchy, and sometimes painful over a long period. The study is testing a treatment called Ruxolitinib cream, which is applied to the skin. This cream is being compared to a Vehicle Cream, which looks and feels the same but does not contain the active ingredient.

The purpose of the study is to evaluate how effective and safe Ruxolitinib cream is for treating adults with moderate to severe Chronic Hand Eczema. Participants in the study will be randomly assigned to use either the Ruxolitinib cream or the Vehicle Cream for a period of 16 weeks. During this time, neither the participants nor the researchers will know which cream is being used, a process known as "double-blind." After this period, all participants will have the opportunity to use the Ruxolitinib cream in an open-label extension, meaning everyone will know they are using the active treatment.

The study will monitor participants' skin condition and any changes in symptoms such as itching and pain. The goal is to see if the Ruxolitinib cream can improve the symptoms of Chronic Hand Eczema more effectively than the Vehicle Cream. Participants will be regularly assessed to track their progress and any side effects they might experience. This trial aims to provide valuable information on the potential benefits of Ruxolitinib cream for people suffering from this persistent skin condition.

The research process

The trial runs in 6 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 participant will be required to sign a consent form, confirming understanding and agreement to participate.
Eligibility criteria include being 18 years or older, having a diagnosis of chronic hand eczema for at least 6 months, and meeting specific itch and skin condition scores.
Step 2
Initial assessment
An initial assessment will be conducted to evaluate the severity of the eczema and to establish baseline scores for itch and skin pain.
Step 3
Treatment phase
Participants will be randomly assigned to receive either ruxolitinib cream or a vehicle cream without the active substance.
The cream should be applied to the affected areas of the hands as directed, typically twice daily, for a period of 16 weeks.
Step 4
Follow-up visits
Regular follow-up visits will be scheduled to monitor progress and any changes in symptoms.
Assessments will include measuring improvements in itch and skin pain scores, as well as overall skin condition.
Step 5
Open-label extension
After the initial 16-week period, participants may enter an open-label extension phase where all will receive ruxolitinib cream.
This phase allows for continued monitoring and assessment of long-term effects.
Step 6
Final evaluation
A final evaluation will be conducted to assess the overall effectiveness and safety of the treatment.
Participants will be asked to provide feedback on their experience and any changes in their condition.

Who can join the trial?

7 criteria

Must be able to understand and willing to sign a written consent form to participate in the study.
Must be at least 18 years old at the time of the screening visit.
Must have been diagnosed with **Chronic Hand Eczema (CHE)** for at least 6 months before the screening. CHE is a type of eczema that lasts more than 3 months or has come back at least twice in the past year.
Must have a **screening and baseline IGA-CHE score** of 3 or 4. This score is a way to measure the severity of the eczema.
Must have a **baseline CHE-related Itch NRS score** of 4 or higher. This score is an average of how itchy the eczema has been over the 7 days before starting the study.
Must have been treated with at least one prescription therapy for CHE, or if such treatment was not suitable or advised against.
Must agree to avoid pregnancy or fathering children during the study and for a certain period after the last application of the study cream. This includes taking precautions to prevent pregnancy and not donating sperm or eggs during this time.

Who cannot join the trial?

7 criteria

Participants with any other skin condition that might interfere with the study.
Individuals who have used certain medications that could affect the study results.
People with a history of allergic reactions to the study cream or similar products.
Participants who are pregnant or breastfeeding.
Individuals with a serious medical condition that could affect their safety during the study.
People who have participated in another clinical trial recently.
Individuals who are unable to follow the study procedures or instructions.

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Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland

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Investigated drugs

Ruxolitinib Cream is a topical medication used in this study to treat chronic hand eczema. It is applied directly to the skin and works by reducing inflammation and itching associated with eczema. The study aims to evaluate its effectiveness and safety in adults with moderate to severe cases of this condition.

Ruxolitinib

What is already known about the treatment

Ruxolitinib Cream – This medication is administered topically as a cream and is currently being studied in clinical trials for its effectiveness in treating chronic hand eczema. It is in the phase 2 stage of clinical trials, where its safety and efficacy are being evaluated. The main therapeutic indication for ruxolitinib cream is moderate to severe chronic hand eczema. At the molecular level, ruxolitinib works by inhibiting certain enzymes known as Janus kinases (JAKs), which play a role in the inflammatory process. It is classified pharmacologically as a JAK inhibitor.

Investigated diseases

Chronic Hand Eczema – Chronic Hand Eczema is a persistent skin condition affecting the hands, characterized by inflammation, redness, and itching. It often results in dry, cracked, and thickened skin, which can be painful and may interfere with daily activities. The condition tends to flare up periodically, with symptoms worsening and then improving. It is commonly triggered by irritants or allergens, such as chemicals or frequent hand washing. Over time, the skin may become more sensitive and prone to further irritation. Managing the condition involves identifying and avoiding triggers to help reduce flare-ups.