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

Primary Purpose

Chronic Hand Dermatitis

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Pimecrolimus Cream 1%
Sponsored by
Novartis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hand Dermatitis focused on measuring Chronic hand dermatitis, pimecrolimus, dermatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome 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

    Full Information

    First Posted
    September 26, 2005
    Last Updated
    February 13, 2008
    Sponsor
    Novartis
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00226707
    Brief Title
    Pimecrolimus Cream 1% in Patients (18 Years of Age and Over) With Mild to Moderate Chronic Hand Dermatitis
    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%
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2004 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    March 2005 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Novartis

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Hand Dermatitis
    Keywords
    Chronic hand dermatitis, pimecrolimus, dermatitis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Double
    Allocation
    Randomized
    Enrollment
    652 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    Pimecrolimus Cream 1%
    Other Intervention Name(s)
    Elidel
    Primary Outcome Measure Information:
    Title
    Investigators Global Assessment (IGA) of the target hand at day 43 or at time of early discontinuation.
    Secondary Outcome Measure Information:
    Title
    IGA of the non-target hand
    Title
    Itching/burning assessment for the target and non-target hand
    Title
    Non-key signs of hand dermatitis (vesiculation, oozing/crusts, edema/population, lichenification) at each study visit
    Title
    Work productivity and activity impairment questionnaire

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    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. Other protocol-defined inclusion/exclusion criteria may apply.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Novartis Pharmaceuticals Japan
    Organizational Affiliation
    Novartis Pharmaceuticals
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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