Safety and Efficacy of Pimecrolimus Cream 1% in Mild to Moderate Head and Neck Atopic Dermatitis (AD) Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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|
- The percentage of patients who have a facial Investigator's Global Assessment (IGA) score of 0 or 1 (clear or almost clear)
- 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
|Study Start Date:||October 2004|
|Study Completion Date:||July 2005|
Pimecrolimus Cream 1 %
Other Name: Elidel
Placebo Comparator: 2
Matching vehicle cream (placebo)
Vehicle cream (placebo cream)