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

Dermatitis, Atopic Clinical Trial

— Ointment TS-AD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02627989
• Other study ID #: 18690
• Status: Completed
• Start date: December 10, 2015
• Est. completion date: January 17, 2017

Study information

• Verified date: January 2018
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: January 17, 2017
• Est. primary completion date: November 17, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic

Intervention

Drug:
• Diflucortolone valerate (Nerisona)
Potency Class II (classified as Very Strong class in Japan) topical corticosteroids
• Diflucortolone valerate (Texmeten)
Potency Class II (classified as Very Strong class in Japan) topical corticosteroids

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
LEO Pharma	Bayer

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 treatment	10 months
Secondary	Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)		10 months
Secondary	Itchiness according to Visual Analogue Scale (VAS)		10 months
Secondary	Severity Scoring of Atopic Dermatitis (SCORAD)		10 months
Secondary	Eczema Area and Severity Index (EASI)		10 months

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