Background/Objective: Tacrolimus ointment is approved for the treatment of moderate to severe atopic dermatitis (AD). We sought to evaluate the efficacy and safety of tacrolimus ointment 0.03% compared with vehicle in the treatment of patients with mild to moderate AD. Methods: Two identically designed, independent, randomized, double-blind, 6-week studies - one pediatric and one adult - in patients with mild to moderate AD were conducted. Combined data from 617 patients were used in the analysis. The primary efficacy end point was percentage of patients with treatment success (defined as "clear" or "almost clear" on the Investigator's Global AD Assessment) at end of study. Results: As early as day 4, treatment success occurred in 17.7% of patients treated with tacrolimus compared with 9.8% of patients treated with vehicle (P = .003), and by study end had increased to 49.7% for tacrolimus versus 29.0% for vehicle (P < .0001). Tacrolimus was associated with significantly less application site pruritus than vehicle (29.0% vs 37.5%; P = .03). There was no difference between tacrolimus and vehicle in the incidence of application site skin burning and stinging. Conclusion: Tacrolimus ointment 0.03% is effective and safe for the management of mild to moderate AD in both adult and pediatric patients, and has a rapid onset of action.
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