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

NCT ID: NCT00226707

Last Updated: 2008-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 652 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2005-03-31

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.

Conditions

Chronic Hand Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Pimecrolimus Cream 1%

Intervention Type: DRUG

Other Intervention Names

Elidel

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharmaceuticals Japan

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Other Identifiers

CASM981M2301

Identifier Type: -

Identifier Source: org_study_id