Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Topical steroids are standard of care for Chronic Hand Dermatitis, but long-term use is associated with adverse effects. This study will assess the efficacy and safety of pimecrolimus cream 1% in patients with mild-to-moderate chronic hand dermatitis.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pimecrolimus Cream 1% | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation. |
| Measure | Description | Time Frame |
|---|---|---|
| IGA of the non-target hand | ||
| Itching/burning assessment for the target and non-target hand | ||
| Non-key signs of hand dermatitis (vesiculation, oozing/crusts, edema/population, lichenification) at each study visit |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals Japan | Novartis Pharmaceuticals | Study Chair |
Not provided
Not provided
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C117268 | pimecrolimus |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Work productivity and activity impairment questionnaire |