5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
- Conditions
- Atopic Dermatitis
- Interventions
- Drug: Topical corticosteroids
- Registration Number
- NCT00120523
- Lead Sponsor
- MEDA Pharma GmbH & Co. KG
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2418
- Aged 3 to < 12 months
- Diagnosis of AD fulfilling the diagnostic criteria of Seymour
- AD affecting at least 5% total body surface area
- Investigator's Global Assessment (IGA) score of 2 or 3, corresponding to mild-to-moderate disease at baseline
- Informed consent
- Phototherapy, systemic therapy (e.g., immunosuppressants, cytostatics), systemic corticosteroids within 4 weeks
- Topical tacrolimus or pimecrolimus within 2 weeks
- Topical therapy (e.g., tar, topical corticosteroids) within 3 days
- Immunocompromised (e.g., lymphoma, AIDS, Wiskott-Aldrich Syndrome) or have a history of malignant disease
- Active acute viral skin infection (e.g. herpes simplex, herpes zoster, chicken pox), and/or clinically infected AD
- Failure to thrive (e.g., weight or height/length below the 5th percentile) or developmental abnormalities such as head circumference less than 5th and more than 95th percentile
- Known hypersensitivity to any ingredient of pimecrolimus cream 1% or topical corticosteroids
- Clinical conditions other than AD that according to investigator can interfere with the evaluation
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 Topical corticosteroids Topical corticosteroids 1 Pimecrolimus Pimecrolimus
- Primary Outcome Measures
Name Time Method Safety Assessed by Adverse Events throughout the 5-year study 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
Growth Velocity (Height) throughout the 5-year study Growth Velocity (Weight) throughout the 5-year study Potential Effect on the Developing Immune System throughout the 5-year study 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.
- Secondary Outcome Measures
Name Time Method Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate throughout the 5-year study 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.Body Surface Area Involved With Atopic Dermatitis throughout the 5-year study TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) throughout the 5-year study 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.Vital Signs and Physical Examinations: Blood Pressure (BP) throughout the 5-year study Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Vital Signs and Physical Examinations: Pulse throughout the 5-year study Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.
Trial Locations
- Locations (31)
Children's Skin Center
🇺🇸Miami, Florida, United States
Dermatology Research Associates
🇺🇸Cincinnati, Ohio, United States
Novartis
🇩🇪Investigative Site, Germany
Dermatology Center for Children
🇺🇸Minneapolis, Minnesota, United States
University of Minnesota - Dept. of Dermatology
🇺🇸Minneapolis, Minnesota, United States
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
Wayne State University Dermatology
🇺🇸Detroit, Michigan, United States
9540 Artesia Blvd., Suite #1
🇺🇸Bellflower, California, United States
Cholla Pediatrics
🇺🇸Tucson, Arizona, United States
Little Rock Allergy & Asthma Clinic
🇺🇸Little Rock, Arkansas, United States
Allergic Disease and Asthma Center
🇺🇸Greenville, South Carolina, United States
The Pediatric Center
🇺🇸Stone Mountain, Georgia, United States
The Portland Clinic
🇺🇸Beaverton, Oregon, United States
Ohio Pediatrics, Inc.
🇺🇸Huber Heights, Ohio, United States
Calcagno Research and Development
🇺🇸Gresham, Oregon, United States
Arkansas Pediatric Clinic
🇺🇸Little Rock, Arkansas, United States
Pediatric Care Medical Group, Inc.
🇺🇸Huntington Beach, California, United States
Longmont Clinical Research
🇺🇸Longmont, Colorado, United States
Pediatric Research Center of South Florida
🇺🇸Palm Beach Gardens, Florida, United States
AeroAllergy Research Laboratories of Savanah, Inc.
🇺🇸Savannah, Georgia, United States
Michigan State University - Kalamazoo Center for Med Studies
🇺🇸Kalamazoo, Michigan, United States
Respiratory Medicine Research Institute of Michigan
🇺🇸Ypsilanti, Michigan, United States
Capitol Pediatrics & Adolescent Center
🇺🇸Raleigh, North Carolina, United States
University of Tennessee - Dept. of Pediatrics
🇺🇸Memphis, Tennessee, United States
Allergy & Asthma Consultants, LLP
🇺🇸Charleston, South Carolina, United States
Suzanne Bruce& Associates, PA
🇺🇸Houston, Texas, United States
Grand Parkway Pediatrics
🇺🇸Sugar Land, Texas, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
SMDC Health System
🇺🇸Duluth, Minnesota, United States
Dermatology Associates of Rochester, P.C.
🇺🇸Rochester, New York, United States
Radiant Research
🇺🇸Bridgeton, Missouri, United States