Tacrolimus Ointment Pharmacokinetics in Infants With Atopic Dermatitis

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to estimate the systemic exposure to tacrolimus in infants with atopic dermatitis after repeated application of tacrolimus ointment. Efficacy of tacrolimus ointment, evaluated by examination of treated areas, will also be measured.

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

Details

• Lead Sponsor: Astellas Pharma Inc
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Patient is between 3 and 24 months old on Day 1.

• The patient has atopic dermatitis requiring treatment with mid potent topical steroids.

• Patient's disease involves a percentage area to be treated greater than or equal to 5% of the total body surface area

Exclusion Criteria:

• Patient has clinically infected atopic dermatitis.

• Patient has a history of more than two courses of systemic corticosteroid treatment