An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids

Study Overview
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Brief Summary
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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.

Official Title
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An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids

Conditions
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Dermatitis, Atopic

Intervention / Treatment
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* Drug: Diflucortolone valerate (Nerisona)
* Drug: Diflucortolone valerate (Texmeten)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female and male patients with a diagnosis of atopic dermatitis who are treated with Fatty Ointment Potency Class II (Very strong class) TCs Patients who are scheduled to change the formulation of the Potency Class II TC from Fatty Ointment to Ointment (Water in Oil; Water per Oil emulsion) as per investigator's routine treatment practice Patients who are aged over 20 Patients who are able to understand and sign a written informed consent Exclusion Criteria: -Patients participating in an investigational program with interventions outside of routine clinical practice Patients with any contraindication to TCs Patients who are regarded as ineligible by the investigator Patients who are pregnant or breastfeeding For Period 2 (Spring-Summer), patients enrolled in the Period 1

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Diflucortolone valerate (Nerisona/Texmeten)<br>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) | Drug: Diflucortolone valerate (Nerisona)<br>* Potency Class II (classified as Very Strong class in Japan) topical corticosteroids<br>Drug: Diflucortolone valerate (Texmeten)<br>* Potency Class II (classified as Very Strong class in Japan) topical corticosteroids<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) |  | 10 months | 
| Eczema Area and Severity Index (EASI) |  | 10 months |