UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019873 |
|---|---|
| Receipt number | 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 18:54:00 |
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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
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
yamake@clin.medic.mie-u.ac.jp
Public contact
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
yamake@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Mie University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022963
