Abstract | BACKGROUND: OBJECTIVE: METHODS: In two independent 6-week, randomized, multicenter studies of identical design, the efficacy and safety of pimecrolimus cream 1% in children with predominantly moderate AD were compared with vehicle. Pooled data from a total of 403 patients were used in the analysis. The primary efficacy parameter was the Investigator's Global Assessment ( IGA) score. Secondary parameters included Eczema Area and Severity Index (EASI) and severity of pruritus scores. Subjects were also asked to assess their disease control as uncontrolled, limited, good, or complete. RESULTS: Significant therapeutic benefits relative to vehicle were observed in the pimecrolimus-treated group at the first efficacy assessment, 8 days after initial application of the study medication (eg, relief of pruritus). At each subsequent postbaseline visit, pimecrolimus-treated patients showed significant improvement relative to controls in all efficacy measures. The medication was well tolerated. CONCLUSION:
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Authors | Lawrence F Eichenfield, Anne W Lucky, Mark Boguniewicz, Richard G B Langley, Robert Cherill, Katharine Marshall, Christopher Bush, Michael Graeber |
Journal | Journal of the American Academy of Dermatology
(J Am Acad Dermatol)
Vol. 46
Issue 4
Pg. 495-504
(Apr 2002)
ISSN: 0190-9622 [Print] United States |
PMID | 11907497
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Immunosuppressive Agents
- pimecrolimus
- Tacrolimus
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Topics |
- Administration, Topical
- Adolescent
- Child
- Child, Preschool
- Dermatitis, Atopic
(drug therapy, pathology)
- Double-Blind Method
- Female
- Humans
- Immunosuppressive Agents
(administration & dosage, adverse effects)
- Infant
- Male
- Tacrolimus
(administration & dosage, adverse effects, analogs & derivatives)
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