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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

  Show 31 Study Locations
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
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Eczematous
Skin Diseases, Genetic
Pimecrolimus
Tacrolimus
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Dermatologic Agents
Immunologic Factors
Immunosuppressive Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014