Not recruiting

Study on Dupilumab for Treating Nummular Eczema in Patients

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 effects of a medication called Dupilumab on a skin condition known as nummular eczema. Nummular eczema is a type of eczema that causes round, itchy patches on the skin. The medication being tested, Dupilumab, is given as a solution for injection using a pre-filled syringe. It is designed to help reduce the symptoms of eczema by targeting specific proteins in the body that cause inflammation.

The purpose of this study is to evaluate how effective Dupilumab is in treating nummular eczema. Participants in the study will receive either Dupilumab or a placebo, which is a substance with no active medication. The study is conducted in a way that neither the participants nor the researchers know who is receiving the actual medication or the placebo, ensuring unbiased results. The study will last for a period of 16 weeks, during which participants will receive regular injections and have their skin condition monitored by healthcare professionals.

Throughout the study, various aspects of the participants' skin condition will be assessed, including changes in the severity of eczema and overall skin health. The study will also monitor any side effects or adverse reactions to Dupilumab. By the end of the study, researchers hope to determine whether Dupilumab is a safe and effective treatment option for individuals with nummular eczema.

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
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria, such as a diagnosis of nummular eczema and other health assessments.
You will be asked to provide informed consent, which means you agree to participate in the study after understanding all the details and potential risks.
Step 2
Randomization
After confirming eligibility, you will be randomly assigned to one of two groups: one group will receive the medication Dupixent, and the other will receive a placebo, which is a substance with no active medication.
This process is double-blind, meaning neither you nor the study staff will know which group you are in, to ensure unbiased results.
Step 3
Treatment phase
If you are in the Dupixent group, you will receive a 300 mg solution for injection. This medication is administered as a subcutaneous injection, which means it is injected under the skin.
The injections will be given at regular intervals as specified by the study protocol, and you will continue this treatment for a total of 16 weeks.
Step 4
Regular assessments
Throughout the study, you will attend regular visits to monitor your health and the effects of the treatment. These assessments will include checking your eczema symptoms, overall health, and any side effects.
You will also complete questionnaires to evaluate the impact of the treatment on your quality of life and satisfaction with the medication.
Step 5
Final evaluation
At the end of the 16-week treatment period, a final evaluation will be conducted. This will include a comprehensive assessment of your eczema symptoms and any changes in your condition.
The study team will also review any side effects or adverse events you may have experienced during the trial.
Step 6
Follow-up
After completing the treatment phase, there will be a follow-up period to monitor your health and any long-term effects of the treatment.
You will be asked to continue using effective contraception if applicable, and report any significant health changes to the study team.

Who can join the trial?

9 criteria

Must have a clinically confirmed diagnosis of nummular eczema.
Must have a biopsy-proven diagnosis, meaning a small sample of skin has been tested and shows signs of eczema.
Must have an EASI score of 10 or higher. EASI stands for Eczema Area and Severity Index, which measures the extent and severity of eczema.
Must have a PGA score of 3 or higher on a 5-point scale. PGA stands for Physician's Global Assessment, which is a doctor's overall rating of the eczema.
Female patients who can have children must have a negative pregnancy test within 7 days before starting the trial.
Female participants must either be unable to have children or use a medically approved method of contraception during the study. This includes hormonal contraceptives or an intrauterine device (IUD).
Must have a history of using at least mid-potency topical steroids continuously for the last 8 weeks. These are creams or ointments applied to the skin to reduce inflammation.
Must be between 18 and 85 years old and weigh between 40 kg (about 88 lbs) and 160 kg (about 353 lbs).
Must provide signed informed consent, meaning you agree to participate in the study after being informed about all aspects of the trial.

Who cannot join the trial?

1 criterion

Patients who do not have nummular eczema cannot participate. Nummular eczema is a skin condition that causes round, itchy spots.

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Verified sites

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Verified
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany
Verified
Medizinische Hochschule Hannover
Hanover, Germany

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Investigated drugs

Dupilumab is a medication used in this clinical trial to help treat nummular eczema, which is a skin condition that causes itchy, round patches on the skin. Dupilumab works by blocking certain proteins in the body that can cause inflammation and lead to eczema symptoms. By reducing this inflammation, Dupilumab aims to improve the skin condition and provide relief from the discomfort associated with eczema.

Dupilumab

What is already known about the treatment

Dupilumab – Dupilumab is administered as an injection under the skin, typically in the upper arm, thigh, or abdomen. It is currently being studied in clinical trials for its effectiveness in treating nummular eczema, a skin condition characterized by round, itchy patches. Dupilumab works by blocking certain proteins in the body that cause inflammation, helping to reduce symptoms like redness and itching. It is classified as a monoclonal antibody, which is a type of medication designed to target specific molecules in the immune system.

Investigated diseases

Nummular Eczema – Nummular eczema, also known as discoid eczema, is a chronic skin condition characterized by round or oval patches of inflamed skin. These patches are often itchy, red, and may become scaly or crusty. The condition typically appears on the arms, legs, or torso and can vary in size. It progresses with periods of flare-ups and remissions, where symptoms may worsen or improve. The exact cause is unknown, but it is believed to be related to skin barrier dysfunction and environmental factors. Over time, the affected areas may become thickened due to repeated scratching or rubbing.