UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000684 |
|---|---|
| Receipt number | R000000818 |
| Scientific Title | Trial of Photodyamic Therapy for Port Wine Stains (capillary hemangioma) with Talaporfin Sodium |
| Date of disclosure of the study information | 2007/04/18 |
| Last modified on | 2012/11/04 18:35:14 |
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Basic information
Public title
Trial of Photodyamic Therapy for Port Wine Stains (capillary hemangioma) with Talaporfin Sodium
Acronym
Trial of Photodyamic therapy for Port Wine Stains (capillary hemangioma) with Talaporfin Sodium
Scientific Title
Trial of Photodyamic Therapy for Port Wine Stains (capillary hemangioma) with Talaporfin Sodium
Scientific Title:Acronym
Trial of Photodyamic therapy for Port Wine Stains (capillary hemangioma) with Talaporfin Sodium
Region
| Japan |
Condition
Condition
capillary hemangioma
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and efficacy for photodynamic therapy with Talaporfin sodium for capillary hemangioma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety
Key secondary outcomes
Efficacy
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment | Maneuver |
Interventions/Control_1
After single intervenous bolus injection of Talaporfin Sodium,the capillary hemangioma is irradiated with 664nm diode laser.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Patient with capillary hemangioma
2.Patient with capillary hemangioma who has been treated more than 3 months before
Key exclusion criteria
1.Patient with allergy for Talaporfin sodium
2.Patient with hyperphotosensitivity
3.Porphyria
4.Severe liver dysfunction
5.Pregnancy
6.Patient who is taking photosensitive medicine and food
7.Others
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takafumi Ohshiro |
Organization
Keio University, School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Keio University, School of Medicine
Division name
Plastic and Reconstructive Surgery
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Keio University, School of Medicine
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
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 04 | Month | 18 | 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
| 2007 | Year | 01 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2007 | Year | 04 | Month | 18 | Day |
Last modified on
| 2012 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000818
