Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
The study was a one arm non-comparative study. The only study medication was Tacrolimus ointment 0.1% (Protopic ® 0.1%).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tacrolimus ointment | Drug | tacrolimus, single arm, 0.1 ointment |
|
|
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Physician's evaluation of clinical response | 12 weeks | |
| Patient's assessment of global response | 12 weeks | |
| Affected body surface area |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Central Contact | Astellas Pharma GmbH | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brno | Czechia | |||||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 12 weeks |
| Quality of Life at Baseline/Day 1 and Week 12/End of study | 12 weeks |
| Changes of mEASI | 12 weeks |
| Incidence of adverse events during the study, including all clinically significant laboratory values | 12 weeks |
| Hradec Králové |
| Czechia |
| Ostrava | Czechia |
| Pilsen | Czechia |
| Prague | Czechia |
| Tábor | Czechia |
| Ústí nad Labem | Czechia |
| Budapest | Hungary |
| Debrecen | Hungary |
| Győr | Hungary |
| Kecskemét | Hungary |
| Miskolc | Hungary |
| Pécs | Hungary |
| Bialystok | Poland |
| Częstochowa | Poland |
| Gdansk | Poland |
| Katowice | Poland |
| Krakow | Poland |
| Lodz | Poland |
| Lublin | Poland |
| Poznan | Poland |
| Sopot | Poland |
| Szczecin | Poland |
| Warsaw | Poland |
| Wroclaw | Poland |
| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D016559 | Tacrolimus |
| ID | Term |
|---|---|
| D018942 | Macrolides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
Not provided
Not provided