Clinical Trial: Distribution of Tacrolimus in Skin, Atopic Dermatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Study to Determine the Distribution of Tacrolimus in the Skin and the Systemic Pharmacokinetics of Tacrolimus in Adult Patients With Moderate to Severe Atopic Dermatitis

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 Summary: 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.
Sponsor: Astellas Pharma Inc

Current Primary Outcome: Distribution of tacrolimus in the skin after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis. [ Time Frame: Days 1, 2, 15. 18 and 21. ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Systemic pharmacokinetics of tacrolimus after first and repeated application of tacrolimus ointment in adult patients with moderate to severe atopic dermatitis. [ Time Frame: Days 1 and 14 ]

Original Secondary Outcome: Same as current

Information By: Astellas Pharma Inc

Dates:
Date Received: September 21, 2007
Date Started: December 2000
Date Completion:
Last Updated: September 17, 2014
Last Verified: September 2014