5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
1 other identifier
interventional
2,418
2 countries
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Apr 2004
Longer than P75 for phase_3
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
July 11, 2005
CompletedFirst Posted
Study publicly available on registry
July 18, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedResults Posted
Study results publicly available
January 16, 2013
CompletedFebruary 11, 2022
April 1, 2016
6.5 years
July 11, 2005
November 9, 2012
February 4, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
throughout the 5-year study
Growth Velocity (Height)
throughout the 5-year study
Growth Velocity (Weight)
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.
throughout the 5-year study
Secondary Outcomes (5)
Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
throughout the 5-year study
Body Surface Area Involved With Atopic Dermatitis
throughout the 5-year study
Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
throughout the 5-year study
Vital Signs and Physical Examinations: Blood Pressure (BP)
throughout the 5-year study
Vital Signs and Physical Examinations: Pulse
throughout the 5-year study
Study Arms (2)
1
EXPERIMENTALPimecrolimus
2
ACTIVE COMPARATORTopical corticosteroids
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Cholla Pediatrics
Tucson, Arizona, 85741, United States
Arkansas Pediatric Clinic
Little Rock, Arkansas, 72205, United States
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, 72205, United States
9540 Artesia Blvd., Suite #1
Bellflower, California, 90706, United States
Pediatric Care Medical Group, Inc.
Huntington Beach, California, 92647, United States
Longmont Clinical Research
Longmont, Colorado, 80501, United States
Children's Skin Center
Miami, Florida, 33155, United States
Pediatric Research Center of South Florida
Palm Beach Gardens, Florida, 33458, United States
AeroAllergy Research Laboratories of Savanah, Inc.
Savannah, Georgia, 31406, United States
The Pediatric Center
Stone Mountain, Georgia, 30083, United States
Wayne State University Dermatology
Detroit, Michigan, 48201, United States
Michigan State University - Kalamazoo Center for Med Studies
Kalamazoo, Michigan, 49008, United States
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, 48197, United States
SMDC Health System
Duluth, Minnesota, 55805, United States
Dermatology Center for Children
Minneapolis, Minnesota, 55404, United States
University of Minnesota - Dept. of Dermatology
Minneapolis, Minnesota, 55455, United States
Radiant Research
Bridgeton, Missouri, 63044, United States
Dermatology Associates of Rochester, P.C.
Rochester, New York, 14623, United States
Capitol Pediatrics & Adolescent Center
Raleigh, North Carolina, 27609, United States
Dermatology Research Associates
Cincinnati, Ohio, 245230, United States
Ohio Pediatrics, Inc.
Huber Heights, Ohio, 45424, United States
The Portland Clinic
Beaverton, Oregon, 97006, United States
Calcagno Research and Development
Gresham, Oregon, 97030, United States
Allergy & Asthma Consultants, LLP
Charleston, South Carolina, 29414, United States
Allergic Disease and Asthma Center
Greenville, South Carolina, 29607, United States
University of Tennessee - Dept. of Pediatrics
Memphis, Tennessee, 38105, United States
Suzanne Bruce& Associates, PA
Houston, Texas, 77056, United States
Grand Parkway Pediatrics
Sugar Land, Texas, 77479, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
Novartis
Investigative Site, Germany
Related Publications (1)
Sigurgeirsson B, Boznanski A, Todd G, Vertruyen A, Schuttelaar ML, Zhu X, Schauer U, Qaqundah P, Poulin Y, Kristjansson S, von Berg A, Nieto A, Boguniewicz M, Paller AS, Dakovic R, Ring J, Luger T. Safety and efficacy of pimecrolimus in atopic dermatitis: a 5-year randomized trial. Pediatrics. 2015 Apr;135(4):597-606. doi: 10.1542/peds.2014-1990. Epub 2015 Mar 23.
PMID: 25802354DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Clinical Research
- Organization
- MEDA Pharma GmbH & Co. KG
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2005
First Posted
July 18, 2005
Study Start
April 1, 2004
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
February 11, 2022
Results First Posted
January 16, 2013
Record last verified: 2016-04
Data Sharing
- IPD Sharing
- Will not share