NCT04871711

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

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 1)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 487 (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: 2021-05-10
• Primary completion: 2022-10-31
• Completion: 2022-10-31
• First posted: 2021-05-04
• Last updated: 2025-04-08
• Results posted: 2024-09-23

Locations

54 sites across 6 countries: Canada, France, Germany, Italy, Poland, United Kingdom