Phase 3
N=2,418
5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT00120523 ↗Enrolled (actual)
2,418
Serious AEs
18.9%
Results posted
Jan 2013
Primary outcome: Primary: Safety Assessed by Adverse Events — 8.6; 7.8; 5.9; 4.9 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Pimecrolimus (Drug); Topical corticosteroids (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- MEDA Pharma GmbH & Co. KG
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety Assessed by Adverse Events |
8.6; 7.8; 5.9; 4.9; 7.1; 8.8 | — |
| PRIMARY Growth Velocity (Height) |
68.8; 68.8; 71.3; 71.3; 77.0; 76.9 | — |
| PRIMARY Growth Velocity (Weight) |
8.2; 8.2; 8.8; 8.7; 10.2; 10.1 | — |
| PRIMARY Potential Effect on the Developing Immune System |
81.8; 85.2; 89.5; 90.4; 91.9; 94.0 | — |
| SECONDARY Investigator's Global Assessment (to Assess Disease Severity) of the Whole Body and of the Face: Treatment Success Rate |
61.4; 59.6; 66.4; 74.5; 73.9; 79.6 | — |
| SECONDARY Body Surface Area Involved With Atopic Dermatitis |
21.1; 21.3; 5.5; 6.0; 4.3; 3.7 | — |
| SECONDARY Parent's Index of Quality of Life - Atopic Dermatitis (PIQoL-AD) |
8.1; 8.4; 5.8; 6.0; 4.8; 5.0 | — |
| SECONDARY Vital Signs and Physical Examinations: Blood Pressure (BP) |
94.3; 94.7; 96.1; 96.3; 98.6; 98.4 | — |
| SECONDARY Vital Signs and Physical Examinations: Pulse |
116.7; 116.0; 114.2; 114.5; 111.4; 111.7 | — |
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).
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
Data sourced from ClinicalTrials.gov (NCT00120523). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.