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
| Name | Class |
|---|---|
| Bayer | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study intends to investigate patient satisfaction of treatment with Ointment (W/O emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction, treatment adherence, itchiness, and AD severity scores.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diflucortolone valerate (Nerisona/Texmeten) | Adult patients with atopic dermatitis switching from diflucortolone-valerate fatty ointment to ointment (water/oil emulsion) during autumn/ winter (Nov to Feb) or spring/ summer (May to Aug) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diflucortolone valerate (Nerisona) | Drug | Potency Class II (classified as Very Strong class in Japan) topical corticosteroids |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9) | A Patient Reported Outcome questionnaire assessing treatment satisfaction by recalling the last 2-3 weeks of treatment | 10 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item) | 10 months | |
| Itchiness according to Visual Analogue Scale (VAS) | 10 months | |
| Severity Scoring of Atopic Dermatitis (SCORAD) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-Patients participating in an investigational program with interventions outside of routine clinical practice
Not provided
Not provided
Not provided
Patients will be recruited by the investigator who will also be the treating physician. As an observational study, only patients who the investigator plans on switching to the ointment (W/O emulsion) from fatty ointment formulation will be eligible to participate. Patients will be recruited for each seasonal phase and same patients may not necessarily be observed between the two seasonal phases.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tsu | Mie-ken | 514-8507 | Japan |
Not provided
Not provided
Not provided
Not provided
| Diflucortolone valerate (Texmeten) | Drug | Potency Class II (classified as Very Strong class in Japan) topical corticosteroids |
|
| 10 months |
| Eczema Area and Severity Index (EASI) | 10 months |
| 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 |
|---|---|
| C013486 | diflucortolone valerate |
Not provided
Not provided
Not provided