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)

March 30, 2020 updated by: LEO Pharma
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Mie
      • Tsu, Mie, Japan, 514-8507

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients will be recruited by the investigator who will also be the treating physician. As an observational study, only patients who the investigator plans on switching to the ointment (W/O emulsion) from fatty ointment formulation will be eligible to participate. Patients will be recruited for each seasonal phase and same patients may not necessarily be observed between the two seasonal phases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diflucortolone valerate (Nerisona/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)
Drug: Diflucortolone valerate (Nerisona)
Potency Class II (classified as Very Strong class in Japan) topical corticosteroids
Drug: Diflucortolone valerate (Texmeten)
Potency Class II (classified as Very Strong class in Japan) topical corticosteroids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Time Frame: 10 months
A Patient Reported Outcome questionnaire assessing treatment satisfaction by recalling the last 2-3 weeks of treatment
10 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)
Time Frame: 10 months
10 months
Itchiness according to Visual Analogue Scale (VAS)
Time Frame: 10 months
10 months
Severity Scoring of Atopic Dermatitis (SCORAD)
Time Frame: 10 months
10 months
Eczema Area and Severity Index (EASI)
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LEO Pharma

Collaborators

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2015

Primary Completion (Actual)

November 17, 2016

Study Completion (Actual)

January 17, 2017

Study Registration Dates

First Submitted

December 9, 2015

First Submitted That Met QC Criteria

December 9, 2015

First Posted (Estimate)

December 11, 2015

Study Record Updates

Last Update Posted (Actual)

April 1, 2020

Last Update Submitted That Met QC Criteria

March 30, 2020

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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