UMIN-CTR Clinical Trial

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
Email	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
Email	shimizuakira@gunma-u.ac.jp

Sponsor
Institute	Gunma university
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000035181