UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030813 |
|---|---|
| Receipt number | R000035181 |
| Scientific Title | Clinical study of a new skin disease |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2021/07/19 12:16:40 |
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Basic information
Public title
Clinical study of a new skin disease
Acronym
Clinical study of a new skin disease
Scientific Title
Clinical study of a new skin disease
Scientific Title:Acronym
Clinical study of a new skin disease
Region
| Japan |
Condition
Condition
hemangioma
Classification by specialty
| Dermatology | Adult | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between the clinical symptom (telangiectasie and hemangioma) and their sex, age, mensturation and delivery.
Basic objectives2
Others
Basic objectives -Others
none
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The association between the existence of telangiectasie and papular hemangioma and thieir number and patients' age.
Key secondary outcomes
The association between the existence of telangiectasie and papular hemangioma and experience of delively and menstruation.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Observation
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
| 1 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) 0-100 years old, male and female
2) Patients who agreed with consent form
Key exclusion criteria
1)Patients with liver disease
2)Patients medicated with hormone
3)Patients applied with topical ointment
4)Patients who was judged as ineligible by research officer.
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Shimizu, Osamu Ishikawa |
Organization
Gunma university
Division name
Dermatology
Zip code
Address
showamachi
TEL
0272208284
shimizuakira@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akira Shimizu |
Organization
Gunma university
Division name
Dermatology
Zip code
Address
showamachi
TEL
0272208284
Homepage URL
shimizuakira@gunma-u.ac.jp
Sponsor or person
Institute
Gunma university
Institute
Department
Personal name
Funding Source
Organization
self sustaning
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 01 | Month | 15 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 07 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035181
