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.

Condition	Intervention	Phase
Atopic Dermatitis	Drug: Pimecrolimus Cream 1%	Phase IV

Further Study Details: 

Ages Eligible for Study:  12 Years and above,  Genders Eligible for Study:  Both

Criteria

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

Switzerland
      This study is not being conducted in the United States, Novartis Pharma AG,  Switzerland

Study chairs or principal investigators

Novartis Pharmaceuticals,  Study Chair,  Novartis   

Study ID Numbers:  ASM981C2442
Last Updated:  August 1, 2005
Record first received:  July 13, 2005
ClinicalTrials.gov Identifier:  NCT00121316
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration; Canada: Health Canada; France: Afssaps - French Health Products Safety Agency; Italy: Ministry of Health; Sweden: Medical Products Agency
ClinicalTrials.gov processed this record on 2005-08-23