Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

The main phase is 6 months duration, but the follow up phase up to 12 months will allow the collection of efficacy and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect atopic dermatitis course.

Inclusion criteria

• Patient may be male or female of any ethnic group
• Patient without restricted legal competence, and suffers from moderate to severe atopic dermatitis (Rajka/Langeland score of at least 4.5)
• Patient known to be responsive to topical steroids
• Patient is capable of understanding the purposes and risks of the trial and has given written Informed Consent
• Female patients of childbearing potential must agree to maintain adequate birth control practice during the trial period and during the first four weeks after the end of the study
• Patient meets the following criteria:

• Topical corticosteroids
• Systemic corticosteroids (for the treatment of AD only)
• Systemic non-steroidal immunosuppressants (e.g. cyclosporine, methotrexate)
• Other investigational drugs
• Light Treatments (UVA, UVB)
• Patient has not taken and agrees not to take for the complete study period any medication or therapy prohibited by the protocol

Exclusion criteria

• Patient has a genetic epidermal barrier defect such as Netherton's syndrome or generalised erythroderma
• Patient is pregnant or breast-feeding
• Patient has a skin infection on the affected (and to be treated) area
• Patient has a known hypersensitivity to macrolides in general, to tacrolimus or any excipient of the ointment
• Patient is simultaneously participating in any other drug trial or less than 28 days have passed between the end of the previous trial and this one
• Any form of substance abuse (including drug or alcohol abuse),psychiatric disorder or condition which, in the opinion of the investigator, may invalidate the communication with the investigator
• Patient is known to be HIV positive