5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis

NCT ID: NCT00120523

Last Updated: 2022-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2418 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-04-30
• Study Completion Date: 2010-10-31

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).

Conditions

Atopic Dermatitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Pimecrolimus

Group Type: EXPERIMENTAL

Pimecrolimus

Intervention Type: DRUG

Pimecrolimus cream 1 %

2

Topical corticosteroids

Group Type: ACTIVE_COMPARATOR

Topical corticosteroids

Intervention Type: DRUG

TCS

Interventions

Pimecrolimus

Pimecrolimus cream 1 %

Intervention Type: DRUG

Topical corticosteroids

TCS

Intervention Type: DRUG

Other Intervention Names

Elidel

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MEDA Pharma GmbH & Co. KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

The Pediatric Center

Stone Mountain, Georgia, United States

Wayne State University Dermatology

Detroit, Michigan, United States

Michigan State University - Kalamazoo Center for Med Studies

Kalamazoo, Michigan, United States

Respiratory Medicine Research Institute of Michigan

Ypsilanti, Michigan, United States

SMDC Health System

Duluth, Minnesota, United States

Dermatology Center for Children

Minneapolis, Minnesota, United States

University of Minnesota - Dept. of Dermatology

Minneapolis, Minnesota, United States

Radiant Research

Bridgeton, Missouri, United States

Dermatology Associates of Rochester, P.C.

Rochester, New York, United States

Capitol Pediatrics & Adolescent Center

Raleigh, North Carolina, United States

Dermatology Research Associates

Cincinnati, Ohio, United States

Ohio Pediatrics, Inc.

Huber Heights, Ohio, United States

The Portland Clinic

Beaverton, Oregon, United States

Calcagno Research and Development

Gresham, Oregon, United States

Allergy & Asthma Consultants, LLP

Charleston, South Carolina, United States

Allergic Disease and Asthma Center

Greenville, South Carolina, United States

University of Tennessee - Dept. of Pediatrics

Memphis, Tennessee, 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

Novartis

Investigative Site, , Germany

Countries

United States; Germany

References

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.

Reference Type: DERIVED

PMID: 25802354 (View on PubMed)

Other Identifiers

CASM981C2306

Identifier Type: -

Identifier Source: org_study_id