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Recruitment status Terminated
Unique ID issued by UMIN UMIN000000684
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Keio University, School of Medicine
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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000818

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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