NCT00691145

Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

A Long-term, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% and 0.03% Tacrolimus (FK506) Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis FG-506-06-IT-01

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to assess the efficacy and safety of 0.1% and 0.03% Tacrolimus ointment for 12 months in adults with moderate to severe atopic dermatitis.

Detailed description

The main phase is 6 months duration, but the follow up phase up to 12 months will allow the collection of efficacy and safety data in a period which will include all seasons in each patient, to account for seasonal variability which strongly affect atopic dermatitis course.

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	tacrolimus ointment	transdermal

Timeline

• Start date: 2002-10-01
• Primary completion: 2005-02-01
• Completion: 2005-02-01
• First posted: 2008-06-05
• Last updated: 2014-09-01

Locations

26 sites across 1 country: Italy