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

NCT00833079 Phase 1 COMPLETED

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.

Details

Lead sponsor	Sun Pharmaceutical Industries, Inc.
Phase	Phase 1
Status	COMPLETED
Enrolment	500
Start date	2008-10
Completion	2010-03

Conditions

• Atopic Dermatitis

Interventions

• Tacrolimus 0.1% manufactured by Taro
• Protopic - Tacrolimus 0.1%
• Tacrolimus Vehicle manufactured by Taro

Primary outcomes

• ISGA score 0 or 1 — 14 days