UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical study to elucidate the efficacy of oral propranolol treatment for infantile hemangiomas
Title of the study (Brief title)	Oral propranolol treatment for infantile hemangiomas
Region	Japan

Condition
Condition	Infantile hemangiomas
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Assessing the efficasy and safety of oral propranolol treatment for infantile hemangiomas
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Change in color and size of infantile hemangiomas, and side effects of propranolol treatment
Key secondary outcomes

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	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral propranolol
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 months-old <=
Age-upper limit	12 months-old >=
Gender	Male and Female
Key inclusion criteria	1.Proliferating infantile hemangiomas 2.Informed consent
Key exclusion criteria	1.Patient who has a severe complication without infantile hemangiomas 2.Patient with the past of serious side effect by the propranolol drug 3.Patient with cardiac disease, asthma or carbohydrate metabolism 4.Patient who was considered ineligible by the investigators
Target sample size	150

Research contact person
Name of lead principal investigator	Ayato Hayashi
Organization	Juntendo University School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Email	ayhayasi@juntendo.ac.jp

Public contact
Name of contact person	Ayato Hayashi
Organization	Juntendo University School of Medicine
Division name	Department of Plastic and Reconstructive Surgery
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo
TEL	03-3813-3111
Homepage URL
Email	ayhayasi@juntendo.ac.jp

Sponsor
Institute	Juntendo University School of Medicine
Institute
Department

Funding Source
Organization	Juntendo University School of Medicine
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2013 Year 10 Month 25 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 10 Month 15 Day
Anticipated trial start date	2013 Year 10 Month 25 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 10 Month 25 Day
Last modified on	2018 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014177