A 12-week study of tacrolimus ointment for the treatment of atopic dermatitis in pediatric patients

The safety and efficacy of 0.03% and 0.1% tacrolimus ointment for the treat ment of atopic dermatitis were evaluated in a 12-week, randomized, double-b lind, vehicle-controlled study of 351 children 2 to 15 years of age with mo derate to severe atopic dermatitis. The mean age of patients was 6.1 years. A total of 61.5% of patients had severe atopic dermatitis at baseline. The mean percentage of body surface area affected was 47.7%, and 83.5% of pati ents were affected on the head and/or neck. Significantly more patients (P < .001) achieved clinical improvement of 90% or better with 0.03% or 0.1% t acrolimus ointment compared with vehicle. Significant improvements in the s igns and symptoms of atopic dermatitis, percent body surface area affected, and the patient's assessment of pruritus were also observed early in treat ment and were maintained throughout the study Adverse events with a statist ically significantly greater incidence in the 0.03% tacrolimus ointment tre atment group compared with vehicle were limited to the sensation of skin bu rning, pruritus, varicella, and vesiculobullous rash ("blisters"). Varicell a and vesiculobullous rash occurred at a low incidence (<5%) No adverse eve nt occurred at a statistically higher incidence in the 0.1% tacrolimus oint ment-treated group compared with vehicle. Tacrolimus ointment was equally s afe for younger (2-6 years) and order (7-15 years) children. Both tacrolimu s ointment concentrations (0.03% and 0.1%) were safe and significantly more effective than vehicle for the treatment of atopic dermatitis in children.