What side effects are associated with this type of intervention?

Common treatments for chronic hand dermatitis, particularly those that suppress inflammation like Delgocitinib cream, include topical corticosteroids and calcineurin inhibitors. The side effects of topical corticosteroids can include skin thinning (atrophy), stretch marks (striae), and increased risk of skin infections. Calcineurin inhibitors, such as tacrolimus and pimecrolimus, may cause burning or itching at the application site and have a potential risk of systemic absorption leading to immunosuppression. It is important to monitor for these side effects and discuss them with a healthcare provider.

What prior FDA approvals exist?

Prior FDA approvals for the treatment of Chronic Hand Dermatitis include topical corticosteroids, which are commonly used to reduce inflammation and alleviate symptoms. Additionally, calcineurin inhibitors like tacrolimus and pimecrolimus have been approved for their anti-inflammatory effects in treating dermatitis. Systemic treatments such as cyclosporine and methotrexate, which also suppress the immune response, have been used in more severe cases. These treatments share a similar mechanism of action to Delgocitinib Cream, which targets specific inflammatory pathways.

What other types of research exist?

Promising novel alternatives to Delgocitinib Cream for chronic hand dermatitis include: <ol> <li>Tofacitinib: An oral Janus kinase (JAK) inhibitor that has shown efficacy in treating various inflammatory skin conditions.</li> <li></li> </ol> Upadacitinib: Another JAK inhibitor that has demonstrated positive results in clinical trials for atopic dermatitis. 3. Abrocitinib: A selective JAK1 inhibitor, effective in reducing inflammation and symptoms in dermatitis patients. 4. Dupilumab: A monoclonal antibody targeting IL-4 and IL-13, approved for atopic dermatitis and showing promise for other inflammatory skin diseases. 5. Baricitinib: An oral JAK inhibitor with potential benefits for dermatitis patients, currently under investigation in various studies.

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Janus Kinase (JAK) Inhibitor

Delgocitinib Cream for Chronic Hand Eczema (DELTA TEEN Trial)

Phase 3

Recruiting

Research Sponsored by LEO Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE.

Subjects who have a documented history of inadequate response to treatment with TCS or for whom TCS are documented to be otherwise medically inadvisable.

Must not have

Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249), systemic or topical.

Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 18

Awards & highlights

Pivotal Trial

Summary

This trial tests if delgocitinib cream can effectively treat chronic hand eczema in children aged 12-17 and examines any side effects. The cream reduces inflammation by targeting specific immune responses. The study lasts several months, with children using the cream regularly. Delgocitinib ointment is a newly approved topical medication for the treatment of atopic dermatitis (AD).

Who is the study for?

This trial is for adolescents aged 12-17 with moderate to severe chronic hand eczema (CHE) that hasn't improved with typical steroid creams or when such treatments aren't suitable. Participants should have had CHE for over 3 months or recurring episodes in the past year, and no other unstable health conditions.

What is being tested?

The trial tests delgocitinib cream's effectiveness against CHE compared to a placebo cream without the active ingredient. Over 22 weeks, participants apply their assigned cream twice daily, determined randomly by computer, and attend eight check-ups.

What are the potential side effects?

Potential side effects of delgocitinib may include skin irritation at the application site, increased risk of infections due to immune response suppression, headaches, and cold symptoms like sore throat and runny nose.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My condition is considered moderate to severe based on a specific assessment.

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I have a history of not responding well to corticosteroid treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have used JAK inhibitors before, either as a pill or a cream.

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I haven't used skin treatments that could affect the trial in the last week, except on my hands.

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I have a skin condition on my hands.

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I have a serious infection on my hands.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 18 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

IGA-CHE treatment success at Week 16

Secondary study objectives

Change in cDLQI score from baseline to Week 16

HECSI-90 at Week 16

IGA-CHE treatment success at Week 12

+7 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Delgocitinib creamExperimental Treatment1 Intervention

Delgocitinib cream 20 mg/g twice daily

Group II: Cream vehiclePlacebo Group1 Intervention

Cream vehicle twice daily

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Delgocitinib

2021

Completed Phase 3

~1330

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Chronic Hand Dermatitis (CHD) include topical corticosteroids, topical immunomodulators, and newer agents like Delgocitinib Cream. Topical corticosteroids work by reducing inflammation and suppressing the immune response, which helps to alleviate the redness, swelling, and itching associated with CHD. Topical immunomodulators, such as tacrolimus and pimecrolimus, inhibit T-cell activation and cytokine release, thereby reducing inflammation and immune activity. Delgocitinib Cream, a Janus kinase (JAK) inhibitor, specifically targets and suppresses inflammatory pathways involved in CHD. These mechanisms are crucial for CHD patients as they directly address the underlying inflammation and immune dysregulation, providing relief from symptoms and improving skin barrier function.

Effects of Delgocitinib Ointment 0.5% on the Normal Mouse Skin and Epidermal Tight Junction Proteins in Comparison With Topical Corticosteroids.A systematic review of evidence based treatments for lichen simplex chronicus.