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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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 18

Awards & highlights

DELTA TEEN Trial Summary

This trial is testing if delgocitinib cream is effective at treating chronic hand eczema in children aged 12-17. There will be a range of assessments that rate the severity and extent of CHE symptoms, general health and quality of life.

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.Check my eligibility

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.See study design

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.

DELTA TEEN Trial 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.

DELTA TEEN Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

IGA-CHE treatment success at Week 16

Secondary outcome measures

Change in cDLQI score from baseline to Week 16

HECSI-90 at Week 16

IGA-CHE treatment success at Week 12

+7 more

DELTA TEEN 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 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor

268 Previous Clinical Trials

188,359 Total Patients Enrolled

Medical ExpertStudy DirectorLEO Pharma

53 Previous Clinical Trials

10,009 Total Patients Enrolled

Media Library

Delgocitinib Cream (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05355818 — Phase 3

Chronic Hand Dermatitis Research Study Groups: Delgocitinib cream, Cream vehicle

Chronic Hand Dermatitis Clinical Trial 2023: Delgocitinib Cream Highlights & Side Effects. Trial Name: NCT05355818 — Phase 3

Delgocitinib Cream (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05355818 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any noted side effects of Delgocitinib?

"There is some evidence of efficacy and extensive data supporting safety, so Delgocitinib was given a score of 3."

Answered by AI

Does this experiment exclude elderly people?

"According to the eligibility requirements, the 84 ongoing studies for patients under 18 or the 118 for those over 65 years old can participate in this clinical trial."

Answered by AI

Are there any patients who have not yet been recruited for this research project?

"That is correct, the online information confirms that the trial is still recruiting patients. 92 individuals from two different locations are required for the study. The trial was first posted on July 14th, 2022 and updated on November 1st, 2022."

Answered by AI

To whom does this study apply? Who can be a part of this research?

"The dermatological study requires that participants have eczema, be between the ages of 12 and 17, and there can only be 92 total enrollees."

Answered by AI

How many people will be able to join this clinical trial?

"That is correct, the online information from clinicaltrials.gov states that this study is still enrolling patients. The study was originally posted on July 14th, 2022 and was most recently updated on November 1st, 2022. A total of 92 patients from 2 different locations are being sought for this trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema

2022. "Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05355818.

All > Eczema