Five-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 to Less Than 12 Months of Age With Mild to Moderate Atopic Dermatitis
Overview
- Phase
- Phase 3
- Intervention
- Pimecrolimus
- Conditions
- Atopic Dermatitis
- Sponsor
- MEDA Pharma GmbH & Co. KG
- Enrollment
- 2418
- Locations
- 31
- Primary Endpoint
- Safety Assessed by Adverse Events
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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).
Investigators
Eligibility 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
Arms & Interventions
1
Pimecrolimus
Intervention: Pimecrolimus
2
Topical corticosteroids
Intervention: Topical corticosteroids
Outcomes
Primary Outcomes
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
Growth Velocity (Height)
Time Frame: throughout the 5-year study
Growth Velocity (Weight)
Time Frame: throughout the 5-year study
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
- Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate(throughout the 5-year study)
- Body Surface Area Involved With Atopic Dermatitis(throughout the 5-year study)
- Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD)(throughout the 5-year study)
- Vital Signs and Physical Examinations: Blood Pressure (BP)(throughout the 5-year study)
- Vital Signs and Physical Examinations: Pulse(throughout the 5-year study)