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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
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 belowSelect...
My condition is considered moderate to severe based on a specific assessment.
Select...
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:Select...
I have used JAK inhibitors before, either as a pill or a cream.
Select...
I haven't used skin treatments that could affect the trial in the last week, except on my hands.
Select...
I have a skin condition on my hands.
Select...
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
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 moreTrial 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
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.
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.
Find a Location
Who is running the clinical trial?
LEO PharmaLead Sponsor
270 Previous Clinical Trials
188,571 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
55 Previous Clinical Trials
10,219 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used JAK inhibitors before, either as a pill or a cream.I haven't taken any immune-suppressing drugs or steroids in the last 28 days, except for certain eye drops or inhalers.My condition is considered moderate to severe based on a specific assessment.I haven't used tanning beds, phototherapy, or bleach baths on my hands in the last 28 days.I haven't used any antibiotics, including creams for my hands, in the last 14 days.I have had hand eczema for over 3 months or it has come back twice in the last year.I haven't used skin treatments that could affect the trial in the last week, except on my hands.I have a skin condition on my hands.I have used skin treatments on my hands in the last 14 days.I haven't used any skin treatments on my hands, except my own moisturizers, in the last 7 days.I have a serious infection on my hands.I have a history of not responding well to corticosteroid treatments.
Research Study Groups:
This trial has the following groups:- Group 1: Delgocitinib cream
- Group 2: Cream vehicle
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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