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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT00120523
First received: July 11, 2005
Last updated: December 10, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Atopic Dermatitis
Drug: Pimecrolimus
Drug: Topical corticosteroids
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by MEDA Pharma GmbH & Co. KG:

Primary Outcome Measures:
  • Safety Assessed by Adverse Events [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: Yes ]
  • Growth Velocity (Weight) [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: Yes ]
  • Potential Effect on the Developing Immune System [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: Yes ]
    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:
  • 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 ] [ Designated as safety issue: No ]

    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 [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: No ]
    TBSA = Total body surface area; percent BSA affected = (BSA affected/TBSA) x 100.

  • Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: No ]

    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) [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: throughout the 5-year study ] [ Designated as safety issue: Yes ]
    Significant findings are included in the relevant medical history/current medical conditions (prior to study start) or in the AE documentation (after study start.


Enrollment: 2418
Study Start Date: April 2004
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Pimecrolimus
Drug: Pimecrolimus
Pimecrolimus cream 1 %
Other Name: Elidel
Active Comparator: 2
Topical corticosteroids
Drug: Topical corticosteroids
TCS

  Eligibility

Ages Eligible for Study:   3 Months to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120523

  Hide Study Locations
Locations
United States, Arizona
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
Cholla Pediatrics
Tuscon, Arizona, United States, 85741
United States, Arkansas
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States, 72205
Arkansas Pediatric 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
Germany
Novartis
Investigative Site, Germany
Sponsors and Collaborators
MEDA Pharma GmbH & Co. KG
  More Information

No publications provided

Responsible Party: MEDA Pharma GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00120523     History of Changes
Other Study ID Numbers: CASM981C2306
Study First Received: July 11, 2005
Results First Received: November 9, 2012
Last Updated: December 10, 2012
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Chile: Instituto de Salud Pública de Chile
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Hong Kong: Department of Health
Netherlands: Medicines Evaluation Board (MEB)
Peru: General Directorate of Pharmaceuticals, Devices, and Drugs
Portugal: National Pharmacy and Medicines Institute
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Singapore: Health Sciences Authority
South Africa: Medicines Control Council
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Taiwan: Department of Health
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pimecrolimus
Tacrolimus
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Immunosuppressive Agents
Immunologic Factors
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 14, 2014