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Arch Dermatol. 2003 Sep;139(9):1184-6.

The safety and efficacy of tacrolimus therapy in patients younger than 2 years with atopic dermatitis.

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Department of Dermatology, Case Western Reserve University, University Hospitals of Cleveland, Cleveland, Ohio 44106, USA.



Atopic dermatitis (AD) is a common inflammatory skin disease that affects adults and children. Tacrolimus (FK 506) ointment is a recently developed topical immunomodulator that has been approved for use in patients with AD who are older than 2 years. Concern regarding potential systemic toxic effects has limited treatment options for children younger than 2 years. We wanted to determine whether topical tacrolimus therapy is safe and effective in patients with AD who are younger than 2 years.


Twelve patients fitting our criteria who were treated with tacrolimus ointment were identified by retrospective chart review. Data collected included severity of AD, response to therapy, concentration and blood levels of tacrolimus, any adverse effects, and results of laboratory tests, including complete blood cell count, liver function tests, and serum chemistry profiles. As the review was retrospective, baseline laboratory studies were not performed. All the patients experienced improvement in their symptoms, and no significant adverse effects were noted. Nine patients used 0.03% tacrolimus ointment; 3 used 0.1%. All patients had blood levels of tacrolimus that were less than 1.5 ng/mL. There was no apparent difference in tacrolimus levels in patients whether they were treated with 0.03% or 0.1% ointment. Four patients had elevated platelet counts.


Tacrolimus ointment appears to be effective and safe in the treatment of AD in children younger than 2 years.

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