UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047643 |
|---|---|
| Receipt number | R000054298 |
| Scientific Title | Prurigo-oriented web-survey regarding treatment and quality of life in Japan |
| Date of disclosure of the study information | 2022/05/02 |
| Last modified on | 2024/02/26 08:53:50 |
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Basic information
Public title
Prurigo-oriented web-survey regarding treatment and quality of life in Japan
Acronym
Prurigo-oriented web-survey in Japan
Scientific Title
Prurigo-oriented web-survey regarding treatment and quality of life in Japan
Scientific Title:Acronym
Prurigo-oriented web-survey in Japan
Region
| Japan |
Condition
Condition
chronic prurigo
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate current disease burden and Factors that associated with disease burden in patients with prurigo nodularis in Japan
Basic objectives2
Others
Basic objectives -Others
Real world data analysis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
-Correlation between demographic characteristics and the following scores
-Correlation between treatment for prurigo nodularis and the following scores
(GQ/NRS/DLQI/SF-8/WPAI/PHQ-9 scores)
Key secondary outcomes
-Correlation between treatment satisfaction for prurigo nodularis and demographic characteristics
-Correlation between treatment satisfaction for prurigo nodularis and the following each score
(GQ/NRS/DLQI/SF-8/WPAI/PHQ-9 scores)
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
-Those who submit their informed consent and agree to participate in the survey
-Those who have been diagnosed with prurigo nodularis by a dermatologist (i.e., introduced by dermatologists to the questionnaire as a patient with prurigo nodularis)
-Those who have visited a medical institution for prurigo nodularis within the past 6 months
-Males and females who are 20 years old or older, reside in Japan, and can understand and answer the questionnaire in Japanese
-The duration of prurigo nodularis is 3 months or longer from the time of the survey.
Key exclusion criteria
-Applicable to inappropriate responses
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Fujita |
Organization
Sanofi K.K.
Division name
Dermatology Medical Immunology Medical Specialty Care
Zip code
1631488
Address
Tokyo Opera City Tower, 3-20- 2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
0363013000
Hiroyuki2.Fujita@sanofi.com
Public contact
Name of contact person
| 1st name | Takuo |
| Middle name | |
| Last name | Yoshida |
Organization
Sanofi K.K.
Division name
Dermatology Medical Immunology Medical Specialty Care
Zip code
1631488
Address
Tokyo Opera City Tower, 3-20- 2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-4575
Homepage URL
Sanofi_Medical@sanofi.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
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
Ethics Review Committee, Kitamachi Clinic, Toukeikai Medical Corporation
Address
1-1-3 Kichijoji-Kita-machi, Musashino-shi, Tokyo
Tel
03-6779-8166
chi-pr-ec-kitamachi@cmicgroup.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
該当なし/not applicable
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 05 | Month | 02 | Day |
Related information
URL releasing protocol
N/A (not available)
Publication of results
Partially published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
359
Results
Thise analysis was performed for 130 dermatologists who see prurigo nodularis (PN) and 97 patients diagnosed with prurigo nodularis by these physicians. The disease burden of patients with PN increased with severity, and satisfaction with treatment was lower with severity. Topical steroids and antihistamines are more common treatment. Variety of drugs were used with increasing severity, but treatment satisfaction was not improved.
Results date posted
| 2023 | Year | 09 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients- Age(+/-SD: 52.1+/-13.0 years old, male:55.7%, duration (+/-SD): 67.0;+/-85.3months
Physicians- Age (under 50):53.8%, dermatologists:100%, JDA certified dermatologists:93.2%
Participant flow
Dermatologists who were registered in Plamed's physician panel who nominated their willingness to participate in the study took part in the study. Patients were also referred to the study by the participating physicians.
Adverse events
not collected
Outcome measures
Patient surveys were conducted on treatment satisfaction and disease burden based on the Itch NRS, Sleep NRS, DLQI, SF-8, WPAI, PHQ-9 and TSQM-9. The physician survey also confirmed the actual state of medical practice.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To understand the perception gap between prurigo nodularis patients and dermatologists (Comparison of patient and physician response rates for factors related to treatment termination, treatment satisfaction, patient communication, and QOL26 questions)
Management information
Registered date
| 2022 | Year | 05 | Month | 02 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054298
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