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: Drug: Diflucortolone valerate (Nerisona); Drug: Diflucortolone valerate (Texmeten)

• 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

Study Timeline

• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-09
• Study Start: 2015-12-10
• Study First Posted: 2015-12-11
• Primary Completion: 2016-11-17
• Study Completion: 2017-01-17
• Status Verified: 2018-01
• Last Update Submitted: 2020-03-30
• Last Update Posted: 2020-04-01

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