NCT05259722

A 24 Week Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

A 24 Week, Randomised, Assessor Blinded, Active-controlled, Parallel Group, Phase 3, 2 Arm Trial to Compare the Efficacy and Safety of Delgocitinib Cream 20 mg/g Twice-daily With Alitretinoin Capsules Once-daily in Adult Participants With Severe Chronic Hand Eczema

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 513 (actual)
• Sponsor: LEO Pharma · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a 24-week study in adult participants with severe chronic hand eczema (CHE) and with a documented inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable. Eligible participants will be randomised to receive topical administration of delgocitinib cream 20 mg/g, twice-daily, or oral administration of alitretinoin capsules 30 mg (with an option to reduce to 10 mg during trial conduct), once-daily. The participants will visit 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 of this trial is to compare the efficacy, health-related quality of life, and safety of delgocitinib cream and alitretinoin capsules.

Conditions

• Chronic Hand Eczema

Interventions

Type	Name	Description
DRUG	Delgocitinib	Cream for topical application 20 mg/g
DRUG	Toctino	1 capsule toctino 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur

Timeline

• Start date: 2022-06-15
• Primary completion: 2023-11-08
• Completion: 2023-12-05
• First posted: 2022-02-28
• Last updated: 2025-05-09
• Results posted: 2025-03-14

Locations

102 sites across 10 countries: Austria, Canada, France, Germany, Italy, Norway, Poland, Slovakia, Spain, United Kingdom