NCT03861455

Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

DUPECZEMAIN : Double Blind Placebo-controlled Randomized Multicenter Study Assessing the Efficacy and Safety of Dupilumab in Moderate to Severe Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 94 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. Investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.

Detailed description

Chronic hand eczema is a frequent chronic inflammatory skin disease which may have significant physical, psychological and social impact on daily activities, emotional and social life as well as work. In Chronic hand eczema, there is a close relationship between atopic dermatitis (that involves 70% of patients), sensitization to environmental antigens and irritant triggering factors. There are limited treatment options for Chronic hand eczema refractory to highly potent topical steroids. The only systemic treatment labelled in Chronic hand eczema, alitretinoin, is associated with moderate efficacy, high drop-out due to adverse events and it requires strict contraception measures in women of child bearing potential. Dupilumab has recently demonstrated high efficacy and good safety profile in the treatment of moderate-to-severe atopic dermatitis. There is a crucial need of developing new treatment options in Chronic hand eczema refractory to topical therapy. the investigators hypothesise that Dupilumab will also have high efficacy and good safety profile in the treatment of moderate to severe Chronic hand eczema refractory to highly potent topical corticosteroids.

Conditions

• Chronic Hand Eczema

Interventions

Type	Name	Description
DRUG	Dupilumab	patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0
DRUG	placebo	patient receive placebo

Timeline

• Start date: 2019-07-15
• Primary completion: 2023-11-09
• Completion: 2023-12-20
• First posted: 2019-03-04
• Last updated: 2024-12-03

Locations

4 sites across 1 country: France