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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00121316

Collaborator

(none)

200

Enrollment

Location

Arms

Duration (Months)

22.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Atopic Dermatitis	Drug: Pimecrolimus Drug: Placebo	Phase 4

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) of Patients Intolerant to, or Dependant on, Topical Corticosteroids

Study Start Date :

Oct 1, 2004

Actual Study Completion Date :

Jul 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Pimecrolimus	Drug: Pimecrolimus Pimecrolimus Cream 1 % Other Names: Elidel
Placebo Comparator: 2 Matching vehicle cream (placebo)	Drug: Placebo Vehicle cream (placebo cream)

Arm

Intervention/Treatment

Experimental: 1

Pimecrolimus

Drug: Pimecrolimus

Pimecrolimus Cream 1 %

Other Names:

Elidel

Placebo Comparator: 2

Matching vehicle cream (placebo)

Drug: Placebo

Vehicle cream (placebo cream)

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Percentage of responders in overall Eczema Area and Severity Index (EASI) score []
Percentage of responders in the head and neck EASI score []
Percentage of patients achieving at least a 60 % reduction from baseline in the head and neck EASI score []
Percentage of patients achieving a score of 0 or 1 for the pruritus score (absent or mild) []
Effects on skin atrophy and telangiectasia (spider veins) existing at baseline []

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts 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