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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02627989

Acronym

Ointment TS-AD

Enrollment

Registered

2015-12-11

Start date

2015-12-10

Completion date

2017-01-17

Last updated

2020-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dermatitis, Atopic

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.

Interventions

DRUGDiflucortolone valerate (Nerisona)

Potency Class II (classified as Very Strong class in Japan) topical corticosteroids

DRUGDiflucortolone valerate (Texmeten)

Potency Class II (classified as Very Strong class in Japan) topical corticosteroids

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026