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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014761
Receipt No. 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

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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
Institute Chiba University Hospital
Institute
Department

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
URL(English) https://upload.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


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