← Back to Search

Janus Kinase (JAK) Inhibitor

Delgocitinib cream for Chronic Hand Dermatitis (DELTA 1 Trial)

Phase 3
Waitlist Available
Research Sponsored by LEO Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens.
Disease severity graded as moderate to severe at screening and baseline according to IGA-CHE (i.e. an IGA-CHE score of 3 or 4).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 16 weeks (18 weeks for participants not participating in the long-term extension trial [lp0133-1403])
Awards & highlights

DELTA 1 Trial Summary

This trial will assess the efficacy of delgocitinib cream in treating adults with chronic hand eczema.

Eligible Conditions
  • Chronic Hand Dermatitis

DELTA 1 Trial Eligibility Criteria

Inclusion Criteria

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

DELTA 1 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~16 weeks (18 weeks for participants not participating in the long-term extension trial [lp0133-1403])
This trial's timeline: 3 weeks for screening, Varies for treatment, and 16 weeks (18 weeks for participants not participating in the long-term extension trial [lp0133-1403]) 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 TS at Week 16
Secondary outcome measures
Change in DLQI score from baseline to Week 16
Change in HEIS PDAL score from baseline to Week 16
Change in HEIS score from baseline to Week 16
+21 more

Side effects data

From 2020 Phase 2 trial • 258 Patients • NCT03683719
17%
Nasopharyngitis
10%
Eczema
6%
Pruritus
6%
Toothache
4%
Headache
2%
Dermatitis atopic
2%
Influenza
2%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Delgocitinib Cream 1 mg/g
Delgocitinib Cream 3 mg/g
Delgocitinib Cream 8 mg/g
Delgocitinib Cream 20 mg/g
Delgocitinib Cream Vehicle

DELTA 1 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Delgocitinib cream 20 mg/gExperimental Treatment1 Intervention
Twice-daily topical application for 16 weeks
Group II: Cream vehiclePlacebo Group1 Intervention
Twice-daily topical application for 16 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Delgocitinib cream
2018
Completed Phase 3
~1600

Find a Location

Who is running the clinical trial?

LEO PharmaLead Sponsor
268 Previous Clinical Trials
188,015 Total Patients Enrolled
Medical ExpertStudy DirectorLEO Pharma
53 Previous Clinical Trials
9,614 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~127 spots leftby Mar 2025