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NCT Number: NCT02627989

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

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.

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Key information

Conditions

Dermatitis, Atopic Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tsu, Mie-ken, 514-8507, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diflucortolone valerate (Nerisona)

Drug

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

Diflucortolone valerate (Texmeten)

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)

    Time frame: 10 months

  2. Itchiness according to Visual Analogue Scale (VAS)

    Time frame: 10 months

  3. Severity Scoring of Atopic Dermatitis (SCORAD)

    Time frame: 10 months

  4. Eczema Area and Severity Index (EASI)

    Time frame: 10 months

Sponsors and collaborators

Lead sponsor

LEO Pharma

Industry

Collaborators

  • Bayer

Registry information

Acronym: Ointment TS-AD

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Dec 11, 2015
Registry last updated
Apr 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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