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Proactive tacrolimus ointment treatment for pediatric atopic dermatitis: A controlled study

A 12-month, European multicenter, randomized, vehicle-controlled study investigated whether proactive twice-weekly 0.03% tacrolimus ointment can maintain atopic dermatitis (AD) in remission and reduce the incidence of disease exacerbation in 267 children aged 2-15 years. An initial open-label phase required children to be treated for up to 6 weeks with 0.03% tacrolimus ointment applied twice daily to the affected areas. When an Investigator's Global Assessment (IGA) score of ≤ 2 was achieved, patients were rerandomized to receive tacrolimus ointment (n=125) or vehicle (n=125) twice weekly for 1 year. Exacerbations were treated with tacrolimus ointment twice daily until an IGA of ≤ 2 was achieved and randomized treatment was restarted. The primary outcome measure was the number ...