UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	Ointment treatment satisfaction for atopic dermatitis patients
Region	Japan

Condition
Condition	atopic dermatitis
Classification by specialty	Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate atopic dermatitis patients' treatment satisfaction when their treatment is switched from Fatty Ointment to Ointment(W/O emulsion)formulations of Potency ClassII topical steroids(TCs).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)
Key secondary outcomes	-Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item) -Treatment effectiveness measured by Visual Analogue Scale (VAS) for itch and change in severity score measured by Severity Scoring of Atopic -Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI).

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Female and male patients with a diagnosis of atopic dermatitis who are treated with Fatty Ointment Potency Class II(Very strong class) TCs 2) Patients who are scheduled to change the formulation of the Potency Class II TC from Fatty Ointment to Ointment (Water in Oil; W/O emulsion) as per investigator's routine treatment practice 3) Patients who are aged over 20 4) Patients who are able to understand and sign a written informed consent
Key exclusion criteria	1) Patients with any contraindication to TCs 2) Patients who are pregnant or breastfeeding 3) Patients who are regarded as ineligible by the investigator
Target sample size	60

Research contact person
Name of lead principal investigator	Keiichi Yamanaka
Organization	Mie University
Division name	Graduate school of medicine, Department of dermatology
Address	2-174 Edobashi, Tsu-shi, Mie Prefecture 514-8507 Japan
TEL	059-232-1111
Email	yamake@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Keiichi Yamanaka
Organization	Mie University
Division name	Department of dermatology, Graduate school of medicine.
Address	2-174 Edobashi, Tsu-shi, Mie Prefecture 514-8507 Japan
TEL	059-232-1111
Homepage URL
Email	yamake@clin.medic.mie-u.ac.jp

Sponsor
Institute	Mie University Hospital
Institute
Department

Funding Source
Organization	Bayer Yakuhin, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	三重大学医学部附属病院（三重県）

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 13 Day
Anticipated trial start date	2015 Year 11 Month 30 Day
Last follow-up date	2016 Year 11 Month 17 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 01 Month 17 Day
Date analysis concluded	2017 Year 06 Month 23 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
Other related information	-Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9) -Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item) -Treatment effectiveness measured by Visual Analogue Scale (VAS) for itch and change in severity score measured by Severity Scoring of Atopic -Dermatitis (SCORAD) and Eczema Area and Severity Index (EASI).

Management information
Registered date	2015 Year 11 Month 20 Day
Last modified on	2018 Year 03 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022963