Trial Condition(s):
Dermatitis, Atopic
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 (Ointment TS-AD)
Bayer Identifier:
18690
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Tsu, Japan, 514-8507 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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 treatmentTimeframe: 10 months
Secondary Outcome
- Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)Timeframe: 10 months
- Itchiness according to Visual Analogue Scale (VAS)Timeframe: 10 months
- Severity Scoring of Atopic Dermatitis (SCORAD)Timeframe: 10 months
- Eczema Area and Severity Index (EASI)Timeframe: 10 months
Additional Information
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