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Completed

NCT Number: NCT00120523

5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 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).

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

3 month–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis, Investigative Site, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pimecrolimus

Drug

Pimecrolimus cream 1 %

Other names: Elidel

Topical corticosteroids

Drug

TCS

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

MEDA Pharma GmbH & Co. KG

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2010
Study completion
2010
First posted
Jul 18, 2005
Registry last updated
Feb 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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