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

NCT00226707 | Completed Phase 3

• 1 other identifier: CASM981M2301
• Study Type: interventional
• Target: 652
• Locations: 0 countries
• Sites: N/A

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

Keywords

Chronic hand dermatitis, pimecrolimus, dermatitis

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (4)

• 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

Interventions

Pimecrolimus Cream 1% DRUG

Also known as: Elidel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Novartis: lead

MeSH Terms

Conditions

Dermatitis

Interventions

pimecrolimus

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Novartis Pharmaceuticals Japan

  Novartis Pharmaceuticals

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2005
• First Posted: September 27, 2005
• Study Start: July 1, 2004
• Study Completion: March 1, 2005
• Last Updated: February 15, 2008

Record last verified: 2008-02