UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060589 |
|---|---|
| Receipt number | R000069262 |
| Scientific Title | PsychOsociaL Disease BUrden in PaTIents with PsOriasis Vulgaris in JapaN Quantitative Study of Psychosocial Burden |
| Date of disclosure of the study information | 2026/02/16 |
| Last modified on | 2026/02/05 15:58:20 |
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Basic information
Public title
PsychOsociaL Disease BUrden in PaTIents with PsOriasis Vulgaris in JapaN Quantitative Study of Psychosocial Burden
Acronym
PsOLUTION
Scientific Title
PsychOsociaL Disease BUrden in PaTIents with PsOriasis Vulgaris in JapaN Quantitative Study of Psychosocial Burden
Scientific Title:Acronym
PsOLUTION
Region
| Japan |
Condition
Condition
Psoriasis Vulgaris
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and validate a comprehensive questionnaire tailored to quantify these psychosocial domains in patients with psoriasis and to implement the validated questionnaire and to use the validated questionnaire with stratified sampling to analyze the psychosocial impact on a larger patient population
Basic objectives2
Others
Basic objectives -Others
Disease of Burden
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
This quantitative study evaluates patient-reported scores across the following eight domains, among patients with PsO, using a questionnaire that will be developed and validated in Step 2A.
The primary endpoints are the Mean Patient Reported Scores in each of the following domains:
1. Daily life
2. Interpersonal relationship
3. Leisure
4. Life course decision
5. Work and Study
6. Psychological Status
7. Financial burden
8. Burden of disease
Please note that the scores for each item are yet to be finalized and will be determined following completion of the validation process in Step 2A. If a significant skew is observed in the distribution of the study population, Median will also be calculated. If the validation results lead to any changes in the study plan, the protocol will be revised, and a modification review will be submitted to the ethics committee (EC).
Key secondary outcomes
The Mean of the Patient Reported Scores for each domain according to the following baseline demographics and clinical characteristics (subject to feasibility of patient numbers)
- baseline BSA category
- age category
- sex category
- disease duration
- lesion in the visible areas
- biological therapy
- topical products
- oral medicines
- phototherapy
Base
Study type
Others,meta-analysis etc
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
| 15 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
- Age at enrollment 15-80 years
- Received a diagnosis of mild-to-severe psoriasis vulgaris (patient self-reported)
- Must live in Japan and be able to communicate in Japanese
- Capable of providing consent to participate in the study
- (For surveys) Must be able to answer online questions
- For participants below 18 years, availability of parents or legal guardians who can sit next to the participants during survey. Parents or legal guardians could enter the enter the answers to the question forms on behalf of the participants, if participants sit next to them and answer vocally.
Key exclusion criteria
- Less than 15 years of age or more than 80 years of age
- Patients with a previous diagnosis of PsA
- Patients exhibiting any joint symptoms
- Patients who have previously experienced any joint symptoms
- For participants below 18 years, unavailability of parents or legal guardians who can sit next to the participants during survey.
In addition, the following exclusion criteria apply to Steps 2A and 2B, respectively:
- Step 2A Pre-test: Unable to attend, understand, and respond to questions posed during an audio-recorded interview conducted using online meeting platform
- Step 2A Pilot-test and 2B: Unable to access the online questionnaire and respond to questions
Target sample size
423
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Ikumi |
Organization
AbbVie GK
Division name
Medical
Zip code
108-0023
Address
3-1-21, Shibaura, Minato-ku, Tokyo, Japan
TEL
080-4817-4830
kyoko.ikumi@abbvie.com
Public contact
Name of contact person
| 1st name | Tang |
| Middle name | |
| Last name | Xiaohe |
Organization
Syneos Health Japan K.K.
Division name
Real World Evidence
Zip code
100-7012
Address
12F JP Tower, 2-7-2 Marunouchi, Chiyoda-ku, Tokyo, Japan
TEL
03-6733-9690
Homepage URL
xiaohe.tang@syneoshealth.com
Sponsor or person
Institute
AbbVie GK
Institute
Department
Personal name
Funding Source
Organization
AbbVie GK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Public Health Research Foundation
Address
1-1-7, Nishiwaseda, Shinjuku-ku, Tokyo, Japan
Tel
03-5287-5070
rinri@phrf.jp
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
| 2026 | Year | 02 | Month | 16 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 10 | Month | 09 | Day |
Date of closure to data entry
| 2026 | Year | 10 | Month | 09 | Day |
Date trial data considered complete
| 2026 | Year | 10 | Month | 16 | Day |
Date analysis concluded
| 2026 | Year | 11 | Month | 10 | Day |
Other
Other related information
In Step 2A, the validity will be confirmed by correlation between the scores of the new questionnaire, HADS-A/D, and DLQI, and internal consistency will be evaluated using Cronbach's alpha. In addition, the items will be modified as necessary, and the retest reliability will be examined by comparison with the retest results of the same respondents. In Step 2B, the responses on the psychosocial burden of psoriasis patients will be organized by descriptive statistics (frequency, proportion, summary value, 95% CI) to understand the characteristics of the burden.
Management information
Registered date
| 2026 | Year | 02 | Month | 05 | Day |
Last modified on
| 2026 | Year | 02 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069262
