Safe treatment of head/neck AD with tacrolimus ointment.

Author(s): Kang S, Paller A, Soter N, Satoi Y, Rico MJ, Hanifin JM

Affiliation(s): Department of Dermatology, University of Michigan Medical Center, 1618 Taubman Center, 1500 E. Medical Center Drive, Ann Arbor, MI 48109-0314, USA. swkang@med.umich.edu

Publication date & source: 2003-06, J Dermatolog Treat., 14(2):86-94.

Publication type: Clinical Trial; Randomized Controlled Trial

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.