UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014761
Receipt number R000017161
Scientific Title An open randomized controlled study of topical timolol maleate gel for the treatment of infant hemangioma: Comparison of safety and efficacy between topical timolol maleate gel and dye laser
Date of disclosure of the study information 2014/10/31
Last modified on 2019/07/24 15:29:21

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Basic information

Public title

An open randomized controlled study of topical timolol maleate gel for the treatment of infant hemangioma: Comparison of safety and efficacy between topical timolol maleate gel and dye laser

Acronym

A controlled study of topical timolol maleate gel for the treatment of infant hemangioma

Scientific Title

An open randomized controlled study of topical timolol maleate gel for the treatment of infant hemangioma: Comparison of safety and efficacy between topical timolol maleate gel and dye laser

Scientific Title:Acronym

A controlled study of topical timolol maleate gel for the treatment of infant hemangioma

Region

Japan


Condition

Condition

Infant hemangioma

Classification by specialty

Pediatrics Dermatology Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We evaluate infant hemangioma treatment with topical timolol maleate gel for safety and efficacy .

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Size and color of tumor.
We evaluate the short-term efficacy and safety with Photo-finish every month.

Key secondary outcomes

Condition of the affected skin.
We check skin complications of the external medication every month.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Pseudo-randomization


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Small amount of 0.5% timolol maleate gel is applied to tumor two times a day for 6 months.

Interventions/Control_2

The current standard dye laser treatment for infant hemangioma in Japan (aggressive irradiation treatment only for proliferative phase of the tumor)

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


Not applicable

Gender

Male and Female

Key inclusion criteria

Superficial infant hemangioma of less than 40 mm in diameter that is located in limbs or truncus.

Key exclusion criteria

Patients who have asthma, cardiovascular malformation, diabetes, poor weight gain, medication (including adrenaline, beta-blocker, calcium antagonist agent, digitalis product, CYP2D6 inhibitor), other skin disease, many infant hemangioma, congenital hemangioma.
Patients who are ruled unfit to this study.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Kaneshige
Middle name
Last name Satoh

Organization

Chiba University Hospital

Division name

Dept. of plastic reconstructive, and aesthetic surgery

Zip code

260-8677

Address

Inohana 1-8-1, Chuo-ku, Chiba city

TEL

043-226-2316

Email

kane.satoh@faculty.chiba-u.jp


Public contact

Name of contact person

1st name Naoaki
Middle name
Last name Rikihisa

Organization

Chiba University Hospital

Division name

Dept. of plastic reconstructive, and aesthetic surgery

Zip code

260-8677

Address

Inohana 1-8-1, Chuo-ku, Chiba city

TEL

043-226-2316

Homepage URL


Email

rikihisa@faculty.chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Chiba University Clinical Research Center

Address

1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN

Tel

043-222-7171

Email

chibacrc@mac.com


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

千葉大学医学部附属病院(千葉県)


Other administrative information

Date of disclosure of the study information

2014 Year 10 Month 31 Day


Related information

URL releasing protocol


Publication of results

Partially published


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

Completed

Date of protocol fixation

2012 Year 11 Month 11 Day

Date of IRB

2012 Year 11 Month 11 Day

Anticipated trial start date

2013 Year 01 Month 01 Day

Last follow-up date

2015 Year 12 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete

2016 Year 03 Month 31 Day

Date analysis concluded

2016 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 08 Month 05 Day

Last modified on

2019 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017161


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name