NCT00523952

Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients

A 12-week, Exploratory, Non-comparative, Multi-centre Study to Evaluate the Efficacy and Safety of 0.1% Tacrolimus Ointment Administered in Adults With Moderate to Severe Atopic Dermatitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 303 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Objective: Assess efficacy and safety of tacrolimus ointment when used in adults with moderate or severe atopic dermatitis. The ointment was applied on the affected skin twice daily for 3 weeks and then once daily until all lesions were cleared

Detailed description

The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).

Conditions

• Dermatitis, Atopic

Interventions

Type	Name	Description
DRUG	tacrolimus ointment	tacrolimus, single arm, 0.1 ointment

Timeline

• Start date: 2004-01-01
• Primary completion: 2005-09-01
• Completion: 2005-09-01
• First posted: 2007-09-03
• Last updated: 2014-09-01

Locations

25 sites across 3 countries: Czechia, Hungary, Poland