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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047643
Receipt No. 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 2022/05/02

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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 Atopic dermatitis
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
Email 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
Email Sanofi_Medical@sanofi.com

Sponsor
Institute Sanofi K.K.
Institute
Department

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
Email 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
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 Open public recruiting
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
2022 Year 05 Month 02 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054298

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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