Official Title: “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%”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Pimecrolimus Cream 1%

Primary Measures

• Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation.

Secondary Measures

• 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

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Lead Sponsor: Novartis

Overall Clinical Trial Officials and Contacts

Novartis Pharmaceuticals Japan Study Chair Novartis Pharmaceuticals  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00226707

Study ID Number: CASM981M2301

ClinicalTrials.gov Identifier: NCT00226707

Health Authority: United States: Food and Drug Administration