The safety and efficacy of
tacrolimus ointment 0.1% (Protopic) in the treatment of
atopic dermatitis of the eyelids were assessed in an open-label clinical trial of 21 patients with moderate to severe eyelid
dermatitis. Of those 21 patients, 20 received study
drug and were followed. Patients applied
tacrolimus ointment 0.1% twice daily for 8 weeks and were followed for 2 additional weeks after the last day of treatment. Complete eye examinations were conducted throughout the study. Efficacy was assessed through the investigator's evaluation of the patients' individual signs and symptoms of eyelid
dermatitis and the physician global assessment (
PGA) of eyelid clinical response. Improvement in the investigator's evaluation of the signs and symptoms of eyelid
dermatitis was observed during the study. A total of 80% of patients (16/20) experienced marked improvement or better in
PGA at 8 weeks. Adverse events were limited to local burning and
itching after the first few applications of study medication. Of the 20 patients, 12 reported burning (60%), and 5 reported
itching (25%). There was no statistically significant increase in intraocular pressure (IOP) during the study compared with baseline. In addition, none of the patients developed
cataracts or
glaucoma during the study. In summary,
tacrolimus ointment 0.1% may be a safe and effective treatment option for patients with moderate to severe eyelid
dermatitis.