Abstract

background: Atopic dermatitis(AD) with head and neck involvement is common and therapeutically challenging.methods: Efficacy and safety data specific to treatment of head/neck regions with tacrolimus ointment (Protopic®) from three double‐blind, randomized, vehicle‐controlled studies are reported. A total of 631 adult and 352 pediatric patients with moderate to severe atopic dermatitis applied the vehicle, 0.03% or 0.1% tacrolimus ointment twice daily to affected areas for up to 12 weeks.results: Significant improvements from baseline to end of treatment for signs of atopic dermatitis (erythema, edema, excoriation, oozing, scaling, and lichenification) were noted for head/neck and non‐head/neck areas treated with either 0.03% or 0.1% tacrolimus ointment (p<0.001). Within each treatment group, the overall 12‐week adjusted incidence rate of application site adverse events was similar for both head/neck and non‐head/neck areas. The incidence of common adverse events such as pruritus, “skin burning”, erythema, infection, and skin tingling in head/neck areas was comparable to that observed in non‐head/neck areas within each treatment group. The overall prevalence of application site adverse events decreased rapidly during the first few days of treatment.conclusion: Tacrolimus ointment is a safe and effective treatment for atopic dermatitis on the head and neck.

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