Distribution of Tacrolimus in Skin, Atopic Dermatitis

Phase 2

Completed

• Conditions: Dermatitis, Atopic

• Registration Number: NCT00534508
• Lead Sponsor: Astellas Pharma Inc

Brief 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%.

Detailed Description

The study was conducted on an out-patient basis, with patients self-administering the ointment twice daily at home. However, on Days 1 and 14 there was only a single application of ointment and this was applied by the Investigator or his/her designee in the clinic. An area of the affected skin was selected for skin biopsy of sufficient size for 5 biopsy samples. The biopsy samples were taken from the same lesion(s) if possible or from an adjacent lesion in the same anatomical area at all times. All areas selected for treatment were treated with tacrolimus ointment 0.1% for a period of two weeks with a follow up period of one week. Two pharmacokinetic profiles (Days 1 and 14) and five skin biopsy samples (Days 1, 2, 15, 18 and 21) were taken.

Study Timeline

• Study Start: 2000-12
• Primary Completion: 2001-07
• Study Completion: 2001-07
• Study First Submitted: 2007-09-21
• Study First Submitted QC: 2007-09-21
• Study First Posted: 2007-09-26
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-17
• Last Update Posted: 2014-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Distribution of tacrolimus in the skin after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis.	Days 1, 2, 15. 18 and 21.

Secondary Outcome Measures

Name	Time	Method
Systemic pharmacokinetics of tacrolimus after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis.	Days 1 and 14