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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00120523
Recruitment Status : Completed
First Posted : July 18, 2005
Results First Posted : January 16, 2013
Last Update Posted : May 25, 2016
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Drug: Pimecrolimus Drug: Topical corticosteroids Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : April 2004
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arm Intervention/treatment
Experimental: 1
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel

Active Comparator: 2
Topical corticosteroids
Drug: Topical corticosteroids

Primary Outcome Measures :
  1. Safety Assessed by Adverse Events [ Time Frame: 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

  2. Growth Velocity (Height) [ Time Frame: throughout the 5-year study ]
  3. Growth Velocity (Weight) [ Time Frame: throughout the 5-year study ]
  4. Potential Effect on the Developing Immune System [ Time Frame: 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 :
  1. Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate [ Time Frame: 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.

  2. Body Surface Area Involved With Atopic Dermatitis [ Time Frame: throughout the 5-year study ]
    TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.

  3. Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) [ Time Frame: 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.

  4. Vital Signs and Physical Examinations: Blood Pressure (BP) [ Time Frame: 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.

  5. Vital Signs and Physical Examinations: Pulse [ Time Frame: 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.

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Ages Eligible for Study:   3 Months to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00120523

  Hide Study Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Cholla Pediatrics
Tuscon, Arizona, United States, 85741
United States, Arkansas
Arkansas Pediatric Clinic
Little Rock,, Arkansas, United States, 72205
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States, 72205
United States, California
9540 Artesia Blvd., Suite #1
Bellflower, California, United States, 90706
Pediatric Care Medical Group, Inc.
Huntington Beach, California, United States, 92647
United States, Colorado
Longmont Clinical Research
Longmont, Colorado, United States, 80501
United States, Florida
Children's Skin Center
Miami, Florida, United States, 33155
Pediatric Research Center of South Florida
Palm Beach Gardens, Florida, United States, 33458
United States, Georgia
AeroAllergy Research Laboratories of Savanah, Inc.
Savannah, Georgia, United States, 31406
The Pediatric Center
Stone Mountain, Georgia, United States, 30083
United States, Michigan
Wayne State University Dermatology
Detroit, Michigan, United States, 48201
Michigan State University - Kalamazoo Center for Med Studies
Kalamazoo, Michigan, United States, 49008
Respiratory Medicine Research Institute of Michigan
Ypsilanti, Michigan, United States, 48197
United States, Minnesota
SMDC Health System
Duluth, Minnesota, United States, 55805
Dermatology Center for Children
Minneapolis, Minnesota, United States, 55404
University of Minnesota - Dept. of Dermatology
Minneapolis, Minnesota, United States, 55455
United States, Missouri
Radiant Research
Bridgeton, Missouri, United States, 63044
United States, New York
Dermatology Associates of Rochester, P.C.
Rochester, New York, United States, 14623
United States, North Carolina
Capitol Pediatrics & Adolescent Center
Raleigh, North Carolina, United States, 27609
United States, Ohio
Dermatology Research Associates
Cincinnati, Ohio, United States, 245230
Ohio Pediatrics, Inc.
Huber Heights, Ohio, United States, 45424
United States, Oregon
The Portland Clinic
Beaverton, Oregon, United States, 97006
Calcagno Research and Development
Gresham, Oregon, United States, 97030
United States, South Carolina
Allergy & Asthma Consultants, LLP
Charleston, South Carolina, United States, 29414
Allergic Disease and Asthma Center
Greenville, South Carolina, United States, 29607
United States, Tennessee
University of Tennessee - Dept. of Pediatrics
Memphis, Tennessee, United States, 38105
United States, Texas
Suzanne Bruce& Associates, PA
Houston, Texas, United States, 77056
Grand Parkway Pediatrics
Sugar Land, Texas, United States, 77479
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Investigative Site, Germany
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: MEDA Pharma GmbH & Co. KG Identifier: NCT00120523     History of Changes
Other Study ID Numbers: CASM981C2306
First Posted: July 18, 2005    Key Record Dates
Results First Posted: January 16, 2013
Last Update Posted: May 25, 2016
Last Verified: April 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by MEDA Pharma GmbH & Co. KG:
Atopic dermatitis, children, infants, pimecrolimus

Additional relevant MeSH terms:
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action