What clinical studies were conducted to support the approval of Protopic?
Three randomized, double-blinded, clinical studies using un-medicated ointment were conducted to support approval of Protopic and demonstrate its safety and effectiveness in treating adults and children with moderate to severe eczema.(7,8,9)
In the adult studies of 632 patients, a significantly greater number of patients achieved at least a 90% or better improvement of their eczema with either the 0.1% or 0.03% concentrations of Protopic, based on their physician's global assessment, at 12 weeks compared to those patients who were treated with an un-medicated ointment.(8)
Similarly, a study of 351 patients ages 2 to 15 showed that a significantly greater number of patients had at least 90% or more improvement with Protopic, based on physician global assessment, compared with an un-medicated ointment.(9) Only Protopic Ointment 0.03% is indicated for children aged 2 to 15 years.
These clinical trials also showed that both pediatric and adult eczema patients who used Protopic had an itch reduction 5 times greater than those who used an un-medicated ointment.(8,9)
What is the important safety information for Protopic?
Protopic should not be used by patients who are allergic to any of its ingredients. The most common side effects with the use of Protopic are sensation of skin burning or itching, flu-like symptoms and headaches. Patients using Protopic should avoid natural or artificial sunlight (sun lamps
|SOURCE Astellas Pharmaceuticals|
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