UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049713 |
|---|---|
| Receipt number | R000056593 |
| Scientific Title | A Web-based Survey to Assess Disease Burden among Self-diagnosed Patients with Hidradenitis Suppurativa in Japan |
| Date of disclosure of the study information | 2022/12/07 |
| Last modified on | 2023/03/27 10:51:02 |
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Basic information
Public title
A Web-based Survey to Assess Disease Burden among Self-diagnosed Patients with Hidradenitis Suppurativa in Japan
Acronym
A Web-based Survey to Assess Disease Burden among Self-diagnosed Patients with Hidradenitis Suppurativa in Japan
Scientific Title
A Web-based Survey to Assess Disease Burden among Self-diagnosed Patients with Hidradenitis Suppurativa in Japan
Scientific Title:Acronym
A Web-based Survey to Assess Disease Burden among Self-diagnosed Patients with Hidradenitis Suppurativa in Japan
Region
| Japan |
Condition
Condition
Hidradenitis Suppurativa
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the burden of disease of self-diagnosed HS in Japanese patients
Basic objectives2
Others
Basic objectives -Others
Since all objectives in the present study are exploratory, all objectives are described as exploratory.
To describe the impact of self-diagnosed HS on DLQI
To describe the impact of self-diagnosed HS on each DLQI domain score
To describe sociodemographic characteristics and number of children in a household
To describe health-related information
To describe HS-specific symptom severity, as measured by the PGIS and the HSSA scores
To describe an impact on HRQOL, as measured by HiSQOL and SF-36 scores
To describe pain severity, as measured by sub-scores of HSSA and HiSQOL, and current analgesics use
To describe an impact on ability to work and perform daily life activities, as measured by WPAI: HS
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
DLQI total scores
DLQI domain scores
Sociodemographic characteristics
Health-related information
HSSA scores
WPAI: HS scores
HiSQOL scores
SF-36 scores
Key secondary outcomes
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
| 16 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
-Meet all 3 self-diagnosed criteria based on the JDA guideline
*Presence of nodules (inflamed or noninflamed), sinus tracts (inflamed or noninflamed), follicular papule/pustule (folliiculitis), abscesses, scarring (atrophic, mesh-like, red, hypertrophic, linear, or bridged)
*More than 2 clinical signs at different areas, including axilla, genitofemoral area, perineum, gluteal area, and infra-mammary area of women (under or between breasts)
*Recurrent painful or suppurating lesions more than 2x/6 months
-Aged 16+ years at screening
-Have willingness and ability to provide informed consent
Key exclusion criteria
-Have been diagnosed with HS by physician
-Did not answer all questionnaire
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Okazaki |
| Middle name | |
| Last name | Masateru |
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 | Takeshi |
| Middle name | |
| Last name | Akiyama |
Organization
IQVIA Solutions Japan K.K.
Division name
Real World Evidence Solutions & HEOR
Zip code
108-0074
Address
Keikyu Dai-7 Building 4-10-8 Takanawa, Minato-ku, Tokyo
TEL
070-1640-7263
Homepage URL
takeshi.akiyama@iqvia.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
TEAM MEDICAL CLINIC
Address
1-chome-5-14 Nishishinbashi, Minato City, Tokyo
Tel
03-6206-1020
irb_admin@pjt.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
| 2022 | Year | 12 | Month | 07 | 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
| 2022 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 22 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N.A.
Management information
Registered date
| 2022 | Year | 12 | Month | 07 | Day |
Last modified on
| 2023 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056593
