Clinical trial NCT00120523: 5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Official title: Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Atopic Dermatitis
Keywords: Atopic dermatitis, children, infants, pimecrolimus
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2005-07-18
Enrollment: 2418
Sex: ALL
Minimum age (years): 3
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Safety Assessed by Adverse Events
timeFrame: throughout the 5-year study
measure: Growth Velocity (Height)
timeFrame: throughout the 5-year study
measure: Growth Velocity (Weight)
timeFrame: throughout the 5-year study
measure: Potential Effect on the Developing Immune System
timeFrame: throughout the 5-year study
Secondary outcomes:
measure: Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate
timeFrame: throughout the 5-year study
measure: Body Surface Area Involved With Atopic Dermatitis
timeFrame: throughout the 5-year study
measure: Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)
timeFrame: throughout the 5-year study
measure: Vital Signs and Physical Examinations: Blood Pressure (BP)
timeFrame: throughout the 5-year study
measure: Vital Signs and Physical Examinations: Pulse
timeFrame: throughout the 5-year study
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Tucson
country: United States
facility: Cholla Pediatrics
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Pediatric Clinic
state: Arkansas
city: Little Rock
country: United States
facility: Little Rock Allergy & Asthma Clinic
state: Arkansas
city: Bellflower
country: United States
facility: 9540 Artesia Blvd., Suite #1
state: California
city: Huntington Beach
country: United States
facility: Pediatric Care Medical Group, Inc.
state: California
city: Longmont
country: United States
facility: Longmont Clinical Research
state: Colorado
city: Miami
country: United States
facility: Children's Skin Center
state: Florida
city: Palm Beach Gardens
country: United States
facility: Pediatric Research Center of South Florida
state: Florida
city: Savannah
country: United States
facility: AeroAllergy Research Laboratories of Savanah, Inc.
state: Georgia
city: Stone Mountain
country: United States
facility: The Pediatric Center
state: Georgia
city: Detroit
country: United States
facility: Wayne State University Dermatology
state: Michigan
city: Kalamazoo
country: United States
facility: Michigan State University - Kalamazoo Center for Med Studies
state: Michigan
city: Ypsilanti
country: United States
facility: Respiratory Medicine Research Institute of Michigan
state: Michigan
city: Duluth
country: United States
facility: SMDC Health System
state: Minnesota
city: Minneapolis
country: United States
facility: Dermatology Center for Children
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota - Dept. of Dermatology
state: Minnesota
city: Bridgeton
country: United States
facility: Radiant Research
state: Missouri
city: Rochester
country: United States
facility: Dermatology Associates of Rochester, P.C.
state: New York
city: Raleigh
country: United States
facility: Capitol Pediatrics & Adolescent Center
state: North Carolina
city: Cincinnati
country: United States
facility: Dermatology Research Associates
state: Ohio
city: Huber Heights
country: United States
facility: Ohio Pediatrics, Inc.
state: Ohio
city: Beaverton
country: United States
facility: The Portland Clinic
state: Oregon
city: Gresham
country: United States
facility: Calcagno Research and Development
state: Oregon
city: Charleston
country: United States
facility: Allergy & Asthma Consultants, LLP
state: South Carolina
city: Greenville
country: United States
facility: Allergic Disease and Asthma Center
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee - Dept. of Pediatrics
state: Tennessee
city: Houston
country: United States
facility: Suzanne Bruce& Associates, PA
state: Texas
city: Sugar Land
country: United States
facility: Grand Parkway Pediatrics
state: Texas
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Investigative Site
country: Germany
facility: Novartis
Study officials:
References:
citation: 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.