The Department of Dermatology at Stony Brook University Medical Center is offering patients who have a history of atopic dermatitis and who have been treated for it with Protopic® (tacrolimus ointment) to be involved in a long-term safety study of the medication. The ointment is indicated for short-term use and non-continuous chronic treatment of moderate to severe atopic dermatitis. Protopic remains a Food and Drug Administration-approved treatment for the condition. But a black box warning indicates that the long-term safety of using topical calcineurin inhibitors – a class of agents that includes Protopic – beyond one year of non-continuous use has not been established. The warning also says that rare cases of malignancy have been reported with patients using the ointment.
The long-term safety trial is designed to follow patients who have previously used Protopic or those who continue to use the ointment under prescription guidelines. Qualified participants will receive one physical examination every year and one dermatological examination every other year for the next 10 years. Patients can be any age to qualify. However, each participant must have used Protopic before the age of 16 and for at least six weeks to treat atopic dermatitis. For more information and to enroll in this study, call The Department of Dermatology at 631-444-4274.
