Ongoing Clinical Trials for Hand Dermatitis
There are currently 5 ongoing clinical trials investigating new treatments for hand dermatitis. These studies are testing various medications including tablets taken by mouth and creams applied to the skin, aimed at helping patients with moderate to severe forms of this condition that have not responded well to standard treatments. The trials are being conducted across several European countries including Germany, Netherlands, Poland, and Denmark.
Clinical trial locations
- Denmark
- Germany
- Netherlands
- Poland
Study on the Effectiveness and Safety of Deucravacitinib for Adults with Chronic Hand Eczema
This trial is investigating deucravacitinib, a medication taken by mouth as a 6 mg tablet twice daily, for the treatment of chronic hand eczema. The study is being conducted in Germany and will last for 16 weeks.
Who can participate: Adults aged 18 to 65 years with moderate to severe chronic hand eczema that has lasted more than 3 months or has returned two or more times in the past year. Participants must have an Investigator Global Assessment score of 3 or higher on a scale of 0 to 4, indicating moderate to severe disease. They must have tried topical treatments like creams or ointments for at least 6 weeks without sufficient improvement and be suitable candidates for treatment that affects the whole body. Participants need to have a body mass index between 18 and 35 kg/m² and be able to attend clinic visits and follow study procedures.
Who cannot participate: The trial excludes people under 18 years old, pregnant or breastfeeding women, those with other skin conditions that might interfere with results, people who have used certain medications that could affect the study, those with a history of severe allergic reactions to similar treatments, individuals with serious health conditions that might make participation unsafe, and those currently enrolled in another clinical trial.
What the study measures: The main goal is to see what percentage of patients achieve clear or almost clear skin with at least a 2-point improvement from the start of the study by week 16. The study will also assess changes in skin health, quality of life using the Hand Eczema Questionnaire, and the Hand Eczema Severity Index at various time points throughout the 16 weeks. Participants will complete self-assessments regularly to track their progress.
Deucravacitinib works by selectively blocking a specific enzyme involved in the inflammatory process, helping to reduce inflammation and improve skin condition.
Study Comparing Alitretinoin and Ciclosporin for Patients with Moderate to Very Severe Hand Eczema
This trial, conducted in the Netherlands, is comparing two different oral medications for treating moderate to very severe hand eczema. Participants will receive either alitretinoin or ciclosporin for a period of 24 weeks.
Who can participate: Adults between 18 and 75 years old who have had moderate to very severe hand eczema for at least 3 months. The condition must not have improved with standard treatments, including the use of strong topical corticosteroids for at least 8 weeks in the last 3 months, regular use of moisturizers and protective creams, and avoiding known irritants or allergens. Women who can become pregnant must use at least two types of birth control starting one month before treatment, throughout the study, and for at least one month after finishing treatment, and must take monthly pregnancy tests. Participants must be able to provide written consent and speak and read Dutch.
Who cannot participate: People who do not have hand eczema, those outside the specified age range, and individuals considered part of vulnerable populations such as children, pregnant women, or those unable to give informed consent.
What the study measures: The study’s main focus is comparing how well the two medications work in improving the condition from the start of the study to the end of 24 weeks. Researchers will assess changes in disease severity using the Physician Global Assessment and Hand Eczema Severity Index, quality of life using the Quality Of Life in Hand Eczema Questionnaire at baseline, 12 weeks, and 24 weeks, and any side effects experienced by participants.
Alitretinoin is a retinoid that works by modulating the immune response and reducing inflammation, while ciclosporin is an immunosuppressant that inhibits calcineurin to prevent immune-mediated damage.
Study on Abrocitinib for Patients with Moderate to Severe Chronic Hand Eczema Unresponsive to Corticosteroids
This study in Poland is evaluating abrocitinib, a Janus kinase 1 inhibitor, for people with moderate to severe chronic hand eczema that has not responded to corticosteroid therapy. The trial will run for 32 weeks.
Who can participate: Adults 18 years or older who have had moderate to severe chronic hand eczema for at least 6 months. The condition must be refractory, meaning it does not improve with standard treatments. At both screening and the start of the study, participants must have a hand Physician’s Global Assessment score of 3 or 4, indicating moderate to severe disease. Women of childbearing potential and their male partners must use birth control during the study and for at least 4 weeks after the last dose of medication.
Who cannot participate: People without moderate to severe chronic hand eczema, those outside the specified age range, and individuals from vulnerable populations.
What the study measures: The primary goal is to measure the percent change from baseline in the hand modified Total Lesion Symptom Score at week 16. The study will also evaluate changes at weeks 2, 4, 12, and 16 in various measures including the Hand Eczema Severity Index and other assessment scores. Safety will be monitored throughout the trial through vital signs, laboratory tests, and recording of any adverse events.
Abrocitinib works by inhibiting Janus kinase enzymes, which play a role in the inflammatory process, thereby reducing inflammation and symptoms associated with eczema.
Study on Oral Roflumilast for Treating Chronic Hand Eczema in Adults
This trial in Denmark is studying roflumilast, a PDE4-inhibitor taken orally, for treating chronic hand eczema in adults. The treatment period lasts for up to 28 days, with the study expected to continue until 2028.
Who can participate: Adults between 18 and 75 years old with a Hand Eczema Severity Index score of 18 or higher and an Investigator’s Global Assessment for Chronic Hand Eczema score of 3 or higher, both indicating moderate to severe disease. Participants must have a Body Mass Index of 20 kg/m² or higher, and women of childbearing potential must have a negative pregnancy test and be willing to use safe contraception during the entire study and for at least 1 week after treatment ends. Participants must be able to speak, understand, and read Danish.
Who cannot participate: People under 18 years old, those without chronic hand eczema, and individuals from vulnerable populations who may need special protection or care.
What the study measures: The main goal is to achieve at least a 75% reduction in hand eczema severity after 16 weeks of treatment compared to the start of the trial. Additional evaluations will look at other levels of improvement such as 50%, 90%, or 100% reduction in eczema severity. The study will also assess overall quality of life, satisfaction with treatment, and any side effects experienced. Regular assessments will include the Hand Eczema Severity Index and questionnaires about symptoms such as pain and itchiness.
Roflumilast works by inhibiting the enzyme phosphodiesterase-4, which plays a role in inflammation, thereby reducing the symptoms of eczema.
Study on the Effectiveness and Safety of Ruxolitinib Cream for Adults with Chronic Hand Eczema
This trial, conducted in both Poland and Germany, is testing ruxolitinib cream applied to the skin for treating moderate to severe chronic hand eczema. The study involves a 16-week double-blind period followed by an open-label extension where all participants can use the active cream.
Who can participate: Adults at least 18 years old who have been diagnosed with chronic hand eczema for at least 6 months before screening. The eczema must last more than 3 months or have returned at least twice in the past year. Participants must have a screening and baseline IGA-CHE score of 3 or 4, indicating moderate to severe disease, and a baseline eczema-related Itch score of 4 or higher based on an average over the 7 days before starting the study. They must have been treated with at least one prescription therapy for chronic hand eczema or such treatment was not suitable for them. Participants must agree to avoid pregnancy or fathering children during the study and for a period after the last application of the cream.
Who cannot participate: People with any other skin condition that might interfere with the study, those who have used certain medications that could affect study results, individuals with a history of allergic reactions to the study cream or similar products, pregnant or breastfeeding women, those with serious medical conditions that could affect safety during the study, people who have participated in another clinical trial recently, and individuals unable to follow study procedures or instructions.
What the study measures: The study will monitor improvements in itch and skin pain scores, as well as overall skin condition. Participants will be randomly assigned to receive either ruxolitinib cream or a vehicle cream without the active substance, applying it to affected areas typically twice daily for 16 weeks. Regular follow-up visits will track progress and symptom changes. After the initial period, participants may enter an open-label extension phase where everyone receives ruxolitinib cream for continued monitoring of long-term effects.
Ruxolitinib cream works by inhibiting Janus kinases, enzymes that play a role in the inflammatory process, helping to reduce inflammation and itching associated with eczema.
Summary
The five ongoing clinical trials for hand dermatitis represent diverse approaches to treating this challenging condition. Three trials focus on oral medications taken as tablets, including deucravacitinib, alitretinoin compared with ciclosporin, abrocitinib, and roflumilast. One trial tests a topical treatment, ruxolitinib cream, which is being studied in two countries. All trials target patients with moderate to severe disease who have not responded adequately to standard treatments such as topical corticosteroids.
Germany and Poland each host two trials, while the Netherlands and Denmark each host one. The duration of treatment varies from as short as 28 days for the roflumilast study to 32 weeks for the abrocitinib trial. Most studies include adults aged 18 and older, with some setting upper age limits around 65 to 75 years. All trials emphasize safety monitoring and quality of life assessments alongside measuring improvements in eczema severity.
The medications being tested work through different mechanisms, including JAK inhibitors, PDE4 inhibitors, retinoids, and immunosuppressants, reflecting the variety of therapeutic approaches being explored for this persistent skin condition. Patients interested in participating should discuss eligibility criteria with their healthcare providers, as requirements vary between trials regarding disease duration, severity scores, and previous treatment history.