Efficacy and Safety of Pimecrolimus Cream 1% in Patients (2 to 11 Years Old) With Mild to Moderate Facial Atopic Dermatitis

Novartis1 site in 1 country200 target enrollmentAugust 2005

ConditionsAtopic Dermatitis

InterventionsPimecrolimus Placebo

DrugsPimecrolimus Placebo

Overview

Phase: Phase 4
Intervention: Pimecrolimus
Conditions: Atopic Dermatitis
Sponsor: Novartis
Enrollment: 200
Locations: 1
Primary Endpoint: The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study is not being conducted in the United States of America (USA).

Atopic dermatitis, also called eczema, is characterized by redness, papulation (skin elevation) and pruritus (skin itching). The active ingredient of pimecrolimus inhibits T-cell activation. These cells are involved in the inflammatory component of the disease. This study will test the safety and efficacy of pimecrolimus cream 1% in atopic dermatitis of the face in patients intolerant of, or dependent on, topical corticosteroids.

Registry

clinicaltrials.gov

Start Date

August 2005

End Date

August 2006

Last Updated

18 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis

Eligibility Criteria

Inclusion Criteria

•Mild to moderate facial atopic dermatitis
•Patients intolerant of, or dependent on, topical corticosteroids

Exclusion Criteria

•Concurrent skin diseases (infections)
•Immunocompromised
•Recently received phototherapy or systemic therapy

Arms & Interventions

1

Pimecrolimus

Intervention: Pimecrolimus

2

Pimecrolimus vehicle cream

Intervention: Placebo

Outcomes

Primary Outcomes

The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)

Secondary Outcomes

Percentage of patients who responded to treatment assessed by overall Eczema Area and Severity Index (EASI) and head and neck EASI score
The percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score
The percentage of patients achieving a score of 0 or 1 for pruritus (absent or mild)
Time to clearance of facial IGA (score of 0 or 1)