NCT00833079

Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis

A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Clinical Study to Evaluate the Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives are to establish the therapeutic equivalence of tacrolimus ointment 0.1%, manufactured by Taro Pharmaceuticals Inc. and Protopic® (tacrolimus), 0.1% topical ointment (Astellas Pharma US, Inc.) and to show superiority over vehicle in the treatment of moderate to severe atopic dermatitis. The secondary objectives are to compare the adverse event (AE) profiles of the two ointments and to investigate their systemic absorption at steady state.

Conditions

• Atopic Dermatitis

Interventions

Type	Name	Description
DRUG	Tacrolimus 0.1% manufactured by Taro	Treatment applied as a thin layer to target area twice daily for 14 days
DRUG	Protopic - Tacrolimus 0.1%	Treatment applied as a thin layer to target area twice daily for 14 days
DRUG	Tacrolimus Vehicle manufactured by Taro	Treatment applied as a thin layer to target area twice daily for 14 days

Timeline

• Start date: 2008-10-01
• Primary completion: 2010-02-01
• Completion: 2010-03-01
• First posted: 2009-01-30
• Last updated: 2014-01-22