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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019873
Receipt No. R000022963
Scientific 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
Date of disclosure of the study information 2015/11/20
Last modified on 2018/03/29

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Basic information
Public 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
Acronym Ointment treatment satisfaction for atopic dermatitis patients
Scientific 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
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Keiichi Yamanaka
Organization Mie University
Division name Graduate school of medicine, Department of dermatology
Zip code
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
1st name of contact person
1st name
Middle name
Last name Keiichi Yamanaka
Organization Mie University
Division name Department of dermatology, Graduate school of medicine.
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 11 Month 13 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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