Protopic ointment is licensed to teat severe eczema (atopic dermatitis), and approved for twice-weekly application by the patients.
Protopic ointment’s approval was based on the data demonstrated by two phase-III studies (CONTROL) conducted in 524 adults and children in 13 European countries. The result demonstrated that once patients had responded to twice-daily treatment of their flares with Protopic ointment, continuing treatment to previously affected areas with a twice-weekly regimen significantly reduced the number of flares compared to a flare treatment-only regimen.
Protopic ointment has been marketed in Europe for the treatment of moderate to severe atopic dermatitis in adults and children aged two and over, since 2001.