UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050273 |
|---|---|
| Receipt number | R000057236 |
| Scientific Title | Prevalence, comorbidities, and treatment patterns of patients suffered from prurigo in Japan |
| Date of disclosure of the study information | 2023/02/08 |
| Last modified on | 2024/12/29 18:12:19 |
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Basic information
Public title
Prevalence, comorbidities, and treatment patterns of patients suffered from prurigo in Japan
Acronym
Prevalence, comorbidities, and treatment patterns of patients suffered from prurigo in Japan
Scientific Title
Prevalence, comorbidities, and treatment patterns of patients suffered from prurigo in Japan
Scientific Title:Acronym
EPIPUS-J
Region
| Japan |
Condition
Condition
Prurigo
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the prevalence and incidence of patients who suffer from prurigo or PN and describe comorbidities, HCRU, and current treatment for prurigo and PN
Basic objectives2
Others
Basic objectives -Others
To estimate the prevalence and incidence of patients who suffer from prurigo or PN and describe comorbidities, HCRU, and current treatment for prurigo and PN with/without AD and with/without atopic diathesis
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Annual prevalence of prurigo and PN are calculated by age and gender
Key secondary outcomes
Annual incidence rate of prurigo and PN are calculated by age and gender.
Comorbidities, HCRU, and current treatment for prurigo and PN
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
| Not applicable |
Age-upper limit
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study population consists of the patients diagnosed with prurigo or PN at dermatology in the JMDC Claims database, in 2005 to 2021 for cross-sectional study and in 2020 for retrospective cohort study
Key exclusion criteria
Not applicable
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Arima |
Organization
Sanofi K.K.
Division name
Dermatology Medical Immunology Medical Specialty Care
Zip code
163-1488
Address
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-4575
Sanofi_Medical@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
163-1488
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
Institute
Department
Personal name
Funding Source
Organization
Sanofi
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
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsar@riversideclinic.or.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
該当なし/not applicable
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 08 | Day |
Related information
URL releasing protocol
https://doi.org/10.14924/dermatol.133.1378
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.14924/dermatol.133.1378
Number of participants that the trial has enrolled
7779860
Results
Among individuals registered in the JMDC database, the number of PN in 2021 was 4403 (0.1%); 50.9% were male. 49.6% had comorbid atopic dermatitis and the frequently prescribed medications were topical corticosteroids (64.0%) and antihistamines (50.1%). 10.2% of patients received phototherapy, 8.4% received oral corticosteroids and 2.5% received cyclosporine A.
Results date posted
| 2024 | Year | 12 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Individuals with at least one PN claims (L28.1) within a health insurance database (JMDC)
Participant flow
The study population consisted of patients diagnosed with prurigo or PN in the dermatology section of the JMDC's receipt database. (Cross-sectional study: 2005-2021, retrospective cohort study: 2020)
Adverse events
NA
Outcome measures
To achieve the primary objective, this study will estimate the prevalence of prurigo (All classification: AC) and each 9 individual diseases by classifying three groups as follows according to the guideline for prurigo in 2020 [2] (Refer to Table 1 for detailed definitions of classifications).
Prurigo (not otherwise specified: NOS)
Prurigo chronica multiformis
Prurigo nodularis (PN)
To calculate the prevalence of prurigo with/without atopic diathesis (including AD, asthma, allergy rhinitis and food allergy) and with/without AD for each population (prurigo AC and 9 individual diseases), a sub-cohort will be defined as the population with atopic diathesis or AD comorbidity.
Secondary objective is to target prurigo AC and PN. Only PN cohort will define sub-cohort with/without AD and with/without atopic diathesis.
Exploratory objective is to target only PN cohort.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NA
Management information
Registered date
| 2023 | Year | 02 | Month | 08 | Day |
Last modified on
| 2024 | Year | 12 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057236
