Unique ID issued by UMIN | UMIN000014761 |
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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 |
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
A controlled study of topical timolol maleate gel for the treatment of infant hemangioma
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
A controlled study of topical timolol maleate gel for the treatment of infant hemangioma
Japan |
Infant hemangioma
Pediatrics | Dermatology | Plastic surgery |
Others
NO
We evaluate infant hemangioma treatment with topical timolol maleate gel for safety and efficacy .
Safety,Efficacy
Confirmatory
Pragmatic
Phase II
Size and color of tumor.
We evaluate the short-term efficacy and safety with Photo-finish every month.
Condition of the affected skin.
We check skin complications of the external medication every month.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Medicine |
Small amount of 0.5% timolol maleate gel is applied to tumor two times a day for 6 months.
The current standard dye laser treatment for infant hemangioma in Japan (aggressive irradiation treatment only for proliferative phase of the tumor)
1 | months-old | <= |
Not applicable |
Male and Female
Superficial infant hemangioma of less than 40 mm in diameter that is located in limbs or truncus.
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.
40
1st name | Kaneshige |
Middle name | |
Last name | Satoh |
Chiba University Hospital
Dept. of plastic reconstructive, and aesthetic surgery
260-8677
Inohana 1-8-1, Chuo-ku, Chiba city
043-226-2316
kane.satoh@faculty.chiba-u.jp
1st name | Naoaki |
Middle name | |
Last name | Rikihisa |
Chiba University Hospital
Dept. of plastic reconstructive, and aesthetic surgery
260-8677
Inohana 1-8-1, Chuo-ku, Chiba city
043-226-2316
rikihisa@faculty.chiba-u.jp
Chiba University Hospital
none
Self funding
Chiba University Clinical Research Center
1-8-1 Inohana Chuo-ku Chiba 260-8677, JAPAN
043-222-7171
chibacrc@mac.com
NO
千葉大学医学部附属病院(千葉県)
2014 | Year | 10 | Month | 31 | Day |
Partially published
Completed
2012 | Year | 11 | Month | 11 | Day |
2012 | Year | 11 | Month | 11 | Day |
2013 | Year | 01 | Month | 01 | Day |
2015 | Year | 12 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2016 | Year | 03 | Month | 31 | Day |
2014 | Year | 08 | Month | 05 | Day |
2019 | Year | 07 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017161
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