UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051977 |
|---|---|
| Receipt number | R000059162 |
| Scientific Title | Patient Interviews to investigate psychosocial disease burden in patients with Psoriasis vulgaris in Japan |
| Date of disclosure of the study information | 2023/08/22 |
| Last modified on | 2024/03/10 00:40:07 |
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Basic information
Public title
Patient Interviews to investigate psychosocial disease burden in patients with Psoriasis vulgaris in Japan
Acronym
Patient Interviews to investigate psychosocial disease burden in patients with Psoriasis vulgaris in Japan
Scientific Title
Patient Interviews to investigate psychosocial disease burden in patients with Psoriasis vulgaris in Japan
Scientific Title:Acronym
Patient Interviews to investigate psychosocial disease burden in patients with Psoriasis vulgaris in Japan
Region
| Japan |
Condition
Condition
Psoriasis vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will identify key concepts associated with patients' perception of the psychosocial burden of disease amongst PsO patients in Japan, particularly those who have/had visible skin lesions on exposed areas of the body.
Similarity and difference from past findings reported in studies conducted in other populations globally will be highlighted in order to inform the future development of studies.
Basic objectives2
Others
Basic objectives -Others
Not applicable
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
In this qualitative study, the primary endpoints broadly include the description of the concepts of highest relevance experienced by PsO patients related to the psychosocial burden of disease and how it has impacted their daily lives, social relationships, and life course decisions.
Key secondary outcomes
Not applicable
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Received a diagnosis of mild-to-severe psoriasis vulgaris
-Has or had (within the last 3 years) skin eruptions due to psoriasis affecting any visible site (e.g. head, face, hands, lower legs)
-18+ years of age at the time of screening
-Currently receiving any treatment (including topical, oral, injectable, and phototherapy agents)
-Capable of submitting written informed consent to participate in the study
Key exclusion criteria
Unable to attend or understand and respond to the questions posed during an audio-recorded interview conducted using one of the following formats: online video, in-person, or phone call (online or landline).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masateru |
| Middle name | |
| Last name | Okazaki |
Organization
AbbVie GK.
Division name
Dermatology, Medical
Zip code
108-0023
Address
3-1-21 Shibaura, Minato-ku, Tokyo 108-0023, Japan
TEL
03-4577-1111
masateru.okazaki@abbvie.com
Public contact
Name of contact person
| 1st name | Miyu |
| Middle name | |
| Last name | Okamura |
Organization
Syneos Health Clinical K.K.
Division name
Real World Evidence
Zip code
103-0027
Address
5F, Urbannet Nihonbashi 2-chome Building 2-1-3 Nihonbashi, Chuo-ku, Tokyo
TEL
03-3516-8601
Homepage URL
miyu.okamura@syneoshealth.com
Sponsor or person
Institute
AbbVie GK.
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization Tokyo Allergy and Respiratory Disease Research Institute
Address
3F, Riverside Tower Kuramae 1-8-6 Kuramae, Taito-ku, Tokyo
Tel
080-7360-0910
takahiro.chisaki@inclusion-p.com
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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
| 2023 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 21 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not Applicable
Management information
Registered date
| 2023 | Year | 08 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059162
