NCT00534508

Distribution of Tacrolimus in Skin, Atopic Dermatitis

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 Following First and Repeated Application of the Tacrolimus Ointment.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	Tacrolimus Ointment 0.1%	Twice daily, 14 days treatment

Timeline

• Start date: 2000-12-01
• Primary completion: 2001-07-01
• Completion: 2001-07-01
• First posted: 2007-09-26
• Last updated: 2014-09-18

Locations

1 site across 1 country: Ireland