Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) Patients

Novartis

Status and phase

Completed

Phase 4

Conditions

Atopic Dermatitis

Treatments

Drug: Pimecrolimus

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00121316

CASM981C2442

Details and patient eligibility

About

This study is not being conducted in the United States.

Patients who are intolerant of topical corticosteroids (TCS) have either experienced an adverse event resulting from the use of TCS, or require unacceptable levels of exposure to TCS in order to control their AD. This is of particular concern for patients with recurrent flares on delicate skin areas such as the head and neck.

The purpose of this study is to investigate whether pimecrolimus cream 1%, a non-steroidal anti-inflammatory drug, is efficacious in treating mild to moderate head and neck AD in patients who are intolerant of, or dependent on topical corticosteroids.

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

12 years of age or older
Mild to moderate facial AD at screening (facial IGA 2 - 3)
Patients intolerant of, or dependent on, topical corticosteroids
Diagnosis of atopic dermatitis by the Hanifin and Rajka criteria
For female patients, a negative pregnancy test. Women who are pregnant or who are breast-feeding may not be included in the study. Women of child-bearing potential must follow a medically recognized form of contraception.

Exclusion criteria

At baseline and throughout the study, patients:

Who have AD on greater than 30% of total body surface area in addition to facial eczema
Who have concurrent skin disease (e.g. acne) in the study area or active skin infections (active bacterial, viral or fungal infections or infestations, herpes simplex, herpes zoster, chicken pox), or other conditions that may interfere with the evaluation (e.g. generalized erythroderma, Netherton's syndrome)
Who are immunocompromised (e.g. Lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease (with the exception of treated basal-cell carcinoma)
Who have previously reported poor, no clinical response, or hypersensitivity to topical pimecrolimus cream (Elidel)
Who have received phototherapy (e.g. UVA, UVB) or systemic therapy (e.g.immunosuppressants, corticosteroids, cytostatics) known or suspected to have an effect on AD within 4 weeks of Visit 2
Who have received investigational drugs within 8 weeks of first application of study drug or planned use of other investigational drugs during participation of this study
Who are unlikely to comply with therapy