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

Inclusion Criteria:

• Patient may be male or female of any ethnic group

• Patient without restricted legal competence, and suffers from moderate to severeatopic 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 givenwritten Informed Consent

• Female patients of childbearing potential must agree to maintain adequate birthcontrol practice during the trial period and during the first four weeks after the endof 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 anymedication or therapy prohibited by the protocol

Exclusion Criteria:

• Patient has a genetic epidermal barrier defect such as Netherton's syndrome orgeneralised 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 anyexcipient of the ointment

• Patient is simultaneously participating in any other drug trial or less than 28 dayshave passed between the end of the previous trial and this one

• Any form of substance abuse (including drug or alcohol abuse),psychiatric disorder orcondition which, in the opinion of the investigator, may invalidate the communicationwith the investigator

• Patient is known to be HIV positive