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
Completed
- Conditions
- Dermatitis, Atopic
- Interventions
- Registration Number
- NCT02627989
- Lead Sponsor
- LEO Pharma
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 55
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Diflucortolone valerate (Nerisona/Texmeten) Diflucortolone valerate (Nerisona) 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) Diflucortolone valerate (Nerisona/Texmeten) Diflucortolone valerate (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)
- Primary Outcome Measures
Name Time Method Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9) 10 months A Patient Reported Outcome questionnaire assessing treatment satisfaction by recalling the last 2-3 weeks of treatment
- Secondary Outcome Measures
Name Time Method Eczema Area and Severity Index (EASI) 10 months 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