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Evidence-Based Dermatology: Research Commentary
December 2002

Another Vehicle-Controlled Study of 1% Pimecrolimus in Atopic Dermatitis: How Does It Help Clinicians and Patients, and Is It Ethically Sound?

Author Affiliations

MichaelBigbyMDRosamariaCoronaDSc, MDDamianoAbeniMD,MPHPaoloPasquiniMD,MPHMoysesSzkloMD, MPH, DrPHHywelWilliamsMD

Arch Dermatol. 2002;138(12):1602-1603. doi:10.1001/archderm.138.12.1602

Question: What is the efficacy and safety of 1% pimecrolimus cream compared with vehicle in children with atopic dermatitis (AD)?

Design: A combined analysis of 2 identical randomized controlled clinical trials (N = 403).

Setting: Children attending specialist dermatology units in the United States.

Study Participants: Children and adolescents aged 1 to 17 years with AD as defined by the United Kingdom Working Party's refinement of Hanifin and Rajka's diagnostic criteria. Those entered into the study had to have at least 5% body surface area involvement and investigators' global assessment (IGA) baseline score of 2 to 3 (mild to moderate AD) and no treatment except emollients in the 7 days prior to randomization. Children who had received systemic therapy within 1 month prior to the study were excluded.

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