NCT03683719

Phase 2b Dose-ranging Trial to Evaluate Delgocitinib Cream 1, 3, 8, and 20 mg/g Compared to Delgocitinib Cream Vehicle Over a 16-week Treatment Period in Adult Subjects With Chronic Hand Eczema

A Phase 2b, Double-blind, Randomised, 5-arm, Vehicle-controlled, Dose-ranging Trial to Evaluate the Efficacy and Safety of Twice Daily Topical Application of Delgocitinib Cream 1, 3, 8, and 20 mg/g for 16 Weeks in Adult Subjects With Mild to Severe Chronic Hand Eczema

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 258 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research trial was to test different strengths of a new trial medication, delgocitinib cream 1, 3, 8, and 20 mg/g, and to investigate how treatment with delgocitinib cream affects chronic hand eczema. This was judged by a range of assessments that rate the severity and extent of chronic hand eczema and its symptoms, as well as general health status and quality of life.

Conditions

• Chronic Hand Eczema

Interventions

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

Timeline

• Start date: 2018-11-28
• Primary completion: 2020-03-06
• Completion: 2020-04-20
• First posted: 2018-09-25
• Last updated: 2025-03-12
• Results posted: 2021-04-19

Locations

28 sites across 3 countries: United States, Denmark, Germany

Regulatory

• FDA-regulated drug study