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

July 11, 2005
December 10, 2012
April 2004
October 2010   (final data collection date for primary outcome measure)
  • 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.
Not Provided
Complete list of historical versions of study NCT00120523 on ClinicalTrials.gov Archive Site
  • 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.
Not Provided
Not Provided
Not Provided
 
Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Atopic Dermatitis
  • Drug: Pimecrolimus
    Pimecrolimus cream 1 %
    Other Name: Elidel
  • Drug: Topical corticosteroids
    TCS
  • Experimental: 1
    Pimecrolimus
    Intervention: Drug: Pimecrolimus
  • Active Comparator: 2
    Topical corticosteroids
    Intervention: Drug: Topical corticosteroids
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2418
October 2010
October 2010   (final data collection date for primary outcome measure)

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
Both
3 Months to 12 Months
No
Contact information is only displayed when the study is recruiting subjects
United States,   Germany
 
NCT00120523
CASM981C2306
Not Provided
MEDA Pharma GmbH & Co. KG
MEDA Pharma GmbH & Co. KG
Not Provided
Not Provided
MEDA Pharma GmbH & Co. KG
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP