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

NCT ID: NCT00121316

Last Updated: 2008-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2005-07-31

Brief Summary

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.

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Pimecrolimus

Group Type: EXPERIMENTAL

Pimecrolimus

Intervention Type: DRUG

Pimecrolimus Cream 1 %

2

Matching vehicle cream (placebo)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Vehicle cream (placebo cream)

Interventions

Pimecrolimus

Pimecrolimus Cream 1 %

Intervention Type: DRUG

Placebo

Vehicle cream (placebo cream)

Intervention Type: DRUG

Other Intervention Names

Elidel

Eligibility 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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Novartis

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

This study is not being conducted in the United States

Novartis Pharma AG, , Switzerland

Countries

Switzerland

Other Identifiers

CASM981C2442

Identifier Type: -

Identifier Source: org_study_id