Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis

Study Overview
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Brief Summary
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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.

Official Title
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A 6-Week Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of Pimecrolimus Cream 1% in Patients With Mild-to-Moderate Chronic Hand Dermatitis Followed by a 6-Week Open-Label Phase to Assess the Safety of Pimecrolimus Cream 1%

Conditions
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Chronic Hand Dermatitis

Intervention / Treatment
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* Drug: Pimecrolimus Cream 1%


Participation Criteria
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Eligibility Criteria
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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/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pimecrolimus Cream 1%|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 
| Work productivity and activity impairment questionnaire |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic hand dermatitis, pimecrolimus, dermatitis