Published online August 31, 2005
PEDIATRICS Vol. 116 No. 3 September 2005, pp. e334-e342 (doi:10.1542/peds.2004-2638)
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ELECTRONIC ARTICLE

Tacrolimus Ointment 0.03% Is Safe and Effective for the Treatment of Mild to Moderate Atopic Dermatitis in Pediatric Patients: Results From a Randomized, Double-Blind, Vehicle-Controlled Study

Lawrence A. Schachner, MD*, Cindy Lamerson, MD{ddagger}, Mary P. Sheehan, MD§, Mark Boguniewicz, MD||, Joy Mosser, MD, Sharon Raimer, MD#, Toni Shull, RN**, Eileen Jaracz, PharmD** for the US Tacrolimus Ointment Study Group

* Division of Dermatology and Cutaneous Surgery, University of Miami, Miami, Florida
{ddagger} Nevada Center for Dermatology, Reno, Nevada
§ Fox Chappell Dermatology, Pittsburgh, Pennsylvania
|| Division of Pediatric Allergy and Immunology, Department of Pediatrics, National Jewish Medical and Research Center and University of Colorado School of Medicine, Denver, Colorado
Central Ohio Skin and Cancer, Inc, Columbus, Ohio
# Department of Dermatology, University of Texas Medical Branch, Galveston, Texas
** Astellas Pharma US, Inc, Deerfield, Illinois

Objective. This study was designed to compare the safety and efficacy of tacrolimus ointment 0.03% with vehicle ointment for the treatment of mild to moderate atopic dermatitis (AD) in pediatric patients.

Methods. A total of 317 patients (2–15 years of age) with mild to moderate AD were randomized to receive tacrolimus ointment or vehicle ointment twice daily in a 6-week, multicenter, double-blind study. Efficacy evaluations, including the Investigators' Global Atopic Dermatitis Assessment, eczema area and severity index, percentage of total body surface area affected, and patient assessment of itch occurred at baseline, day 4, and weeks 2, 4, and 6. Cutaneous adverse events were recorded to evaluate safety.

Results. At the end of study, 50.6% (80 of 158) of the patients were treated successfully with tacrolimus ointment based on Investigators' Global Atopic Dermatitis Assessment scores, a significant improvement compared with patients treated with vehicle ointment (25.8% [41 of 159]). The percent improvement from baseline in eczema area and severity index scores was also significantly greater in tacrolimus-treated patients (54.8%) compared with vehicle-treated patients (20.8%). There was also a significant improvement in the percentage of total body surface area affected of tacrolimus-treated patients (50.5% reduction from baseline) compared with vehicle-treated patients (16.4%). Patient itch scores were significantly lower in tacrolimus-treated patients (2.1) versus vehicle-treated patients (3.7). Overall, the incidence of cutaneous adverse events reported was similar for both treatment groups. There was no significant difference in the incidence of burning or stinging between treatment groups. Significantly fewer tacrolimus-treated patients prematurely discontinued from the study because of a cutaneous adverse event in the treatment area or experienced increased itching and erythema at the application site.

Conclusion. Monotherapy with tacrolimus ointment 0.03% is a safe and effective treatment alternative for pediatric patients with mild to moderate AD.

Key Words: atopic dermatitis • pediatrics • tacrolimus ointment • topical immunomodulatory agents

Abbreviations: AD, atopic dermatitis • UV, ultraviolet • BSA, body surface area • IGADA, Investigators' Global Atopic Dermatitis Assessment • EOS, end of study • EASI, eczema area and severity index • %BSA, percentage of total body surface area

Accepted Mar 24, 2005.




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C. M. Palmer and V. B. Lyon
Stepwise Approach to Topical Therapy for Atopic Dermatitis
Clinical Pediatrics, June 1, 2008; 47(5): 423 - 434.
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