Delgocitinib Cream for Chronic Hand Eczema

(DELTA TEEN Trial)

Recruiting at34 trial locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: LEO Pharma

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Research Team

Medical Expert

Principal Investigator

LEO Pharma

Eligibility Criteria

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.

Inclusion Criteria

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

I have had hand eczema for over 3 months or it has come back twice in the last year.

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

Exclusion 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.

I haven't used tanning beds, phototherapy, or bleach baths on my hands in the last 28 days.

Treatment Details

Interventions

• Cream vehicle (Topical Treatment)
• Delgocitinib Cream (Janus Kinase (JAK) Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Delgocitinib cream Experimental Treatment 1 Intervention

Delgocitinib cream 20 mg/g twice daily

Group II: Cream vehicle Placebo Group 1 Intervention

Cream vehicle twice daily

Who Is Running the Clinical Trial?

LEO Pharma

Lead Sponsor

Trials

275

Recruited

189,000+

Christophe Bourdon

LEO Pharma

Chief Executive Officer since 2022

Engineering degree from Université de Technologie de Compiègne

Dr. Siri Torhaug

LEO Pharma

Chief Medical Officer since 2022

MD, PhD