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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
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).
Details
| Lead sponsor | MEDA Pharma GmbH & Co. KG |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 2418 |
| Start date | 2004-04 |
| Completion | 2010-10 |
Conditions
- Atopic Dermatitis
Interventions
- Pimecrolimus
- Topical corticosteroids
Primary outcomes
- Safety Assessed by Adverse Events — 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) — throughout the 5-year study
- Growth Velocity (Weight) — throughout the 5-year study
- Potential Effect on the Developing Immune System — 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.
Countries
United States, Germany