Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids (DUPECZEMAIN)
Efficacy and Safety of Dupilumab Chronic Hands Eczema Refractory to Highly Potent Topical Corticosteroids (DUPECZEMAIN)
ClinicalTrials.gov ID: NCT03861455
Sponsor: University Hospital, Toulouse
Information provided by: University Hospital, Toulouse (Responsible Party)
Last Update Posted: 2023-08-23
Brief 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.
Official Title:
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
Intervention / Treatment:
- Drug: Dupilumab
- Drug: placebo
| Category | Value |
|---|---|
| Study Start (Actual) | 2019-07-15 |
| Primary Completion (Estimated) | 2024-01 |
| Study Completion (Estimated) | 2024-06 |
| Enrollment (Estimated) | 94 |
| Study Type | Interventional |
| Phase | Phase 2 |
| Other Study ID Numbers |
RC31/18/0269
2018-002830-19 (EudraCT Number) |