Bioequivalence of Two Tacrolimus 0.1% Topical Ointment Formulations in Patients With Atopic Dermatitis
Status:
Completed
Trial end date:
2010-03-01
Target enrollment:
Participant gender:
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.