UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of proplanorol for infantile hemangioma
Title of the study (Brief title)	Proplanorol for infantile hemangioma
Region	Japan

Condition
Condition	Infantile Hemangioma
Classification by specialty	Pediatrics Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the efficacy proplanorol to infantile hemangiomas with the risk of life-threatening
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Response rate at 12 weeks
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	Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	oral administration of proplanorol
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	0 years-old <=
Age-upper limit	1 years-old >
Gender	Male and Female
Key inclusion criteria	(1)patients with Infantile Hemangioma in Tohoku University Hospital Department of Pediatrics (2)Infant with huge Hemangioma that on the face and neck, near the eyelid (3)Patients without any organ failure (4) Written consent is necessary.
Key exclusion criteria	Patients with .. cardiogenic shock sinus bradycardia long QT syndrome hypotension atrioventricular block heart failure bronchial asthma infectious diseases hypersensitivity to propranolol Kasabach-Merritt syndrome PHACE syndrome
Target sample size	25

Research contact person
Name of lead principal investigator	Yoji Sasahara
Organization	Tohoku University Hospital
Division name	Department of Pediatrics
Address	1-1 Seiryomachi, Aobaku, Sendai
TEL	022-717-7287
Email	ysasahara@med.tohoku.ac.jp

Public contact
Name of contact person	Takeshi Rikiishi
Organization	Tohoku University Hospital
Division name	Department of Pediatrics
Address	1-1 Seiryomachi, Aobaku, Sendai
TEL	022-717-7287
Homepage URL
Email	trikiishi@med.tohoku.ac.jp

Sponsor
Institute	Tohoku University Hospital
Institute
Department

Funding Source
Organization	Tohoku University Hospital
Organization
Division
Category of Funding Organization	Other
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	2016 Year 01 Month 15 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 12 Month 17 Day
Anticipated trial start date	2016 Year 01 Month 15 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	2015 Year 12 Month 16 Day
Last modified on	2017 Year 06 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000023353