Dermatitis, Atopic
Conditions
Keywords
dermatitis, atopic, tacrolimus, adult
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%).
Interventions
DRUGtacrolimus ointment
tacrolimus, single arm, 0.1 ointment
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Incidence of adverse events during the study, including all clinically significant laboratory values | 12 weeks |
| Physician's evaluation of clinical response | 12 weeks |
| Patient's assessment of global response | 12 weeks |
| Affected body surface area | 12 weeks |
| Quality of Life at Baseline/Day 1 and Week 12/End of study | 12 weeks |
| Changes of mEASI | 12 weeks |
Countries
Czechia, Hungary, Poland
Outcome results
None listed