The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,418
Pimecrolimus cream 1 %
TCS
Safety Assessed by Adverse Events
crude incidence of adverse events of primary interest and most frequent adverse events (greater than or equal to 5% crude incidence in either treatment group) in the treatment period
Time frame: throughout the 5-year study
Growth Velocity (Height)
Time frame: throughout the 5-year study
Growth Velocity (Weight)
Time frame: throughout the 5-year study
Potential Effect on the Developing Immune System
number (%) of patients with positive antibody titers to tetanus, hepatitis B, and measles vaccines at baseline, weeks 26 (6 months), 52 (1 year), 104 (2 years), 156 (3 years), 208 (4 years) and 260 (5 years) Varicella antibody titers were measured at the above time points in US patients only.
Time frame: throughout the 5-year study
Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
IGA = Investigator's global Assessment. CI = Confidence interval for treatment success using binomial distribution: lower CI\<0 is set to 0, upper CI\>100 is set to 100. Treatment success (n): IGA score of 0 or 1 (clear or almost clear). Outcome gives percentage of patients with treatment success.
Time frame: throughout the 5-year study
Body Surface Area Involved With Atopic Dermatitis
TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.
Time frame: throughout the 5-year study
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
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Phoenix Children's Hospital
Phoenix, Arizona, United States
Cholla Pediatrics
Tucson, Arizona, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, United States
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States
9540 Artesia Blvd., Suite #1
Bellflower, California, United States
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States
Longmont Clinical Research
Longmont, Colorado, United States
Children's Skin Center
Miami, Florida, United States
Pediatric Research Center of South Florida
Palm Beach Gardens, Florida, United States
AeroAllergy Research Laboratories of Savanah, Inc.
Savannah, Georgia, United States
...and 21 more locations
PIQoL-AD questionnaire (28 questions) was only done in countries where validated questionnaire was available: Germany, Hungary, Netherlands, Spain, UK and US. For the purposes of data presentation, a "Not True" response was coded a value of zero and a "True" a value of one. The total score (i.e., sum of individual questions) was calculated; lower the score, better the QoL. Minimum score = 0; maximum score = 28. If the patient has answered ≤14 questions at a time point, then the patient's total score at the time point was set to missing.
Time frame: throughout the 5-year study
Vital Signs and Physical Examinations: Blood Pressure (BP)
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Time frame: throughout the 5-year study
Vital Signs and Physical Examinations: Pulse
Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Time frame: throughout the 5-year study