Chronic Hand Dermatitis
Conditions
Keywords
Chronic hand dermatitis, pimecrolimus, dermatitis
Brief summary
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.
Interventions
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Inclusion criteria
* \- Patients who are outpatients at baseline (Day 1) * Patients must be 18 years of age or above * Patients must have chronic hand dermatitis based upon clinical diagnosis with mild to moderate dermatitis of the target hand at baseline, as defined by an Investigator's Global Assessment score of 2 (mild) or 3 (moderate). * Patients must have been informed of the study procedures and medication and have given their written informed consent
Exclusion criteria
* \- Women who are pregnant or who are breast-feeding. * Patients who have received systemic corticosteroids (i.e., oral, intravenous, intra-articular, rectal, intramuscular) within one month prior to first application of study medication. * Patients who have received phototherapy (e.g., UVB, PUVA) or systemic therapy (e.g., immunosuppressants, cytostatics) known or suspected to have an effect on hand dermatitis within at least one month prior to first application of study medication. * Patients who have received pimecrolimus cream 1% or tacrolimus ointment 0.1% or 0.03% within 14 days prior to first application of study medication. * Patients who were treated with topical therapy (e.g., tar, topical corticosteroids, Burrows solution soaks) known or suspected to have an effect on hand dermatitis within 7 days prior to first application of trial medication. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation. | — |
Secondary
| Measure | 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 | — |
| Work productivity and activity impairment questionnaire | — |
Outcome results
None listed