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

• Status: Completed
• Trial end date: 2005-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus ointment for 12 months in adults with moderate to severe atopic dermatitis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

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