UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020220
Receipt number R000023353
Scientific Title Efficacy of proplanorol for infantile hemangioma
Date of disclosure of the study information 2016/01/15
Last modified on 2017/06/17 20:24:05

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Basic information

Public title

Efficacy of proplanorol for infantile hemangioma

Acronym

Proplanorol for infantile hemangioma

Scientific Title

Efficacy of proplanorol for infantile hemangioma

Scientific Title:Acronym

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

1st name
Middle name
Last name Yoji Sasahara

Organization

Tohoku University Hospital

Division name

Department of Pediatrics

Zip code


Address

1-1 Seiryomachi, Aobaku, Sendai

TEL

022-717-7287

Email

ysasahara@med.tohoku.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Rikiishi

Organization

Tohoku University Hospital

Division name

Department of Pediatrics

Zip code


Address

1-1 Seiryomachi, Aobaku, Sendai

TEL

022-717-7287

Homepage URL


Email

trikiishi@med.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University Hospital

Institute

Department

Personal name



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)



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

2016 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

2015 Year 12 Month 17 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023353


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name