Distribution of Tacrolimus in Skin, Atopic Dermatitis

• Status: Completed
• Trial end date: 2001-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This study was designed to further increase the understanding of the pharmacokinetics of tacrolimus in the affected skin of atopic dermatitis patients following repeated topical application of tacrolimus ointment 0.1%.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Using the Hanifin and Rajka Criteria, the patient has a diagnosis of moderate to severe atopic dermatitis

• Using the Rajka and Langeland grading system, the patient's atopic dermatitis score is at least 4.5 (moderate to severe)

Exclusion Criteria:

• Patient has a serious skin disorder other than atopic dermatitis.

• Patient has history of eczema herpeticum (defined as an acute disseminated cutaneous herpes simplex type 1 or 2 infection associated with constitutional symptoms like fever, headache, malaise, regional or generalised lymphadenopathy in an individual with eczema).