NCT04872101

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)

A Phase 3 Clinical Trial to Confirm Efficacy and Evaluate Safety of Twice-daily Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adult Subjects With Moderate to Severe Chronic Hand Eczema (DELTA 2)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 473 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a 16-week study in adult participants with chronic hand eczema (CHE). The participants visited the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

Conditions

• Chronic Hand Eczema

Interventions

Type	Name	Description
DRUG	Delgocitinib cream	Cream for topical application
DRUG	Cream vehicle	The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Timeline

• Start date: 2021-05-25
• Primary completion: 2022-12-27
• Completion: 2023-01-06
• First posted: 2021-05-04
• Last updated: 2025-04-08
• Results posted: 2024-10-17

Locations

50 sites across 7 countries: Belgium, Canada, Denmark, Germany, Netherlands, Poland, Spain