Hand Dermatoses
Conditions
Keywords
Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed
Brief summary
Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to \>75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.
Interventions
DRUGalitretinoin
Sponsors
Basilea Pharmaceutica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Previous participation in protocol BAP089 * Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease
Exclusion criteria
* Female patients who are pregnant or who want to become pregnant * Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient's global assessment | — |
| Extent of disease | — |
| Time to respond | — |
| Modified total lesion symptom score | — |
| at week 12 or 24 | — |
Countries
Germany
Outcome results
None listed