Eczema
Conditions
Keywords
Chronic hand eczema, Chronic hand dermatitis, Patients with chronic hand eczema, who are refractory to topical corticosteroids
Brief summary
The purpose of the study is to investigate the safety and efficacy of alitretinoin in chronic hand eczema that is refractory to topical corticosteroids.
Detailed description
Chronic hand eczema is a frequent and distressing disease. The course of the disease is of chronic-relapsing nature. In a phase III study alitretinoin was clinically effective for patients with severe chronic hand eczema refractory to topical treatment. This study investigates the safety and efficacy of alitretinoin who previously have participated in a clinical trial involving alitretinoin.
Interventions
DRUGalitretinoin
Sponsors
Basilea Pharmaceutica
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Previous participation in therapeutic trials involving chronic hand eczema * Relapse of chronic hand eczema, defined as 75% of the baseline initial total lesion symptom score
Exclusion criteria
* Patients whose disease is adequately controlled by standard non-medicated skin care and topical corticosteroid therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety assessments | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy (Physicians Global Assessment) | — |
Countries
France, Germany
Outcome results
None listed