UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005387 |
|---|---|
| Receipt number | R000006396 |
| Scientific Title | Clinical study to prove the efficacy and safety of topical timolol for infantile hemangiomas |
| Date of disclosure of the study information | 2011/05/09 |
| Last modified on | 2018/10/04 18:41:00 |
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Basic information
Public title
Clinical study to prove the efficacy and safety of topical timolol for infantile hemangiomas
Acronym
Topical timolol for infantile hemangiomas
Scientific Title
Clinical study to prove the efficacy and safety of topical timolol for infantile hemangiomas
Scientific Title:Acronym
Topical timolol for infantile hemangiomas
Region
| Japan |
Condition
Condition
infantile hemangiomas
Classification by specialty
| Pediatrics | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to assess the efficacy and safety of topical timolol for infantile hemangiomas
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
change in size of infantile hemangiomas
Key secondary outcomes
photographic evaluation
evaluation of efficacy by doctor
evaluation of efficacy by family
presence or absence of complications
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
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Group A: dye laser
Interventions/Control_2
Group B: dye laser + topical timolol ophtalmic solution
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 | months-old | <= |
Age-upper limit
| 24 | months-old | > |
Gender
Male and Female
Key inclusion criteria
infantile hemangiomas
Key exclusion criteria
heart disease,
asthma,
severe complication,
allergy for timolol ophtalmic solution
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobukazu Hayashi |
Organization
Toranomon Hospital
Division name
Dermatology
Zip code
Address
2-2-2 Toranomon,Minato-ku,Tokyo
TEL
03-3588-1111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akiko Kishi |
Organization
Toranomon Hospital
Division name
Dermatology
Zip code
Address
2-2-2 Toranomon,Minato-ku,Tokyo
TEL
03-3588-1111
Homepage URL
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Okinaka Memorial Institute for Medical Research
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
虎の門病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 05 | Month | 09 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 26 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 26 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 26 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 04 | Month | 06 | Day |
Last modified on
| 2018 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006396
