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

This is an interventional treatment trial for Dermatitis, Atopic focused on measuring Atopic dermatitis, Tacrolimus ointment Read More

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