Clinical Trial: Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary: The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).
Sponsor: Astellas Pharma Inc
Current Primary Outcome: Rate of patients with at least 50% (i.e. at least moderate) improvement according to the Physician's global evaluation of clinical response between Baseline and the Week 12/End of Study Visit [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Physician's evaluation of clinical response [ Time Frame: 12 weeks ]
- Patient's assessment of global response [ Time Frame: 12 weeks ]
- Affected body surface area [ Time Frame: 12 weeks ]
- Quality of Life at Baseline/Day 1 and Week 12/End of study [ Time Frame: 12 weeks ]
- Changes of mEASI [ Time Frame: 12 weeks ]
- Incidence of adverse events during the study, including all clinically significant laboratory values [ Time Frame: 12 weeks ]
Original Secondary Outcome: Same as current
Information By: Astellas Pharma Inc
Dates:
Date Received: August 31, 2007
Date Started: January 2004
Date Completion:
Last Updated: August 28, 2014
Last Verified: August 2014
