Clinical Trial to Assess the Efficacy and Safety of Tacrolimus Ointment Treatment of Atopic Dermatitis in Adult Patients
- Registration Number
- NCT00523952
- Lead Sponsor
- Astellas Pharma Inc
- 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 Description
The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 303
Inclusion Criteria
- Male or female, any ethnic group, age ≥16
- Moderate to severe atopic dermatitis
- Has given informed consent
Exclusion Criteria
- Erythroderma
- Pregnant or breast-feeding
- Skin infection on the affected area
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 tacrolimus ointment -
- Primary Outcome Measures
Name Time Method 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 12 weeks
- Secondary Outcome Measures
Name Time Method Affected body surface area 12 weeks Patient's assessment of global response 12 weeks Physician's evaluation of clinical response 12 weeks Changes of mEASI 12 weeks Incidence of adverse events during the study, including all clinically significant laboratory values 12 weeks Quality of Life at Baseline/Day 1 and Week 12/End of study 12 weeks