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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007523
Receipt No. R000008884
Scientific Title Photodynamic therapy with oral administration of 5-aminolevulinic acid for the treatment of skin cancers and hair follicle sebaceous glands tumors
Date of disclosure of the study information 2012/03/21
Last modified on 2012/03/18

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Basic information
Public title Photodynamic therapy with oral administration of 5-aminolevulinic acid for the treatment of skin cancers and hair follicle sebaceous glands tumors
Acronym Photodynamic therapy with oral administration of 5-aminolevulinic acid for the treatment of skin cancers and hair follicle sebaceous glands tumors
Scientific Title Photodynamic therapy with oral administration of 5-aminolevulinic acid for the treatment of skin cancers and hair follicle sebaceous glands tumors
Scientific Title:Acronym Photodynamic therapy with oral administration of 5-aminolevulinic acid for the treatment of skin cancers and hair follicle sebaceous glands tumors
Region
Japan

Condition
Condition Skin cancers and hair follicle sebaceous glands tumors
Classification by specialty
Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To test the efficacy of photodynamic therapy with oral administration of 5-aminolevulinic acid in patients with skin cancers and hair follicle sebaceous glands tumors
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of photodynamic therapy with oral administration of 5-aminolevulinic acid
Key secondary outcomes

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
Interventions/Control_1 Oral administration of 5-aminolevulinic acid two hour before therapy.And the lesions will be irradiated with Dye laser(10J/cm2).The treatment will be done once a month for three months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who gave their written informed consent
Key exclusion criteria Patients who meet any of the conditions described below are excluded.
1. Patients with hypersensitivity to 5-ALA or porphyrins.
2. In case of known or suspected pregnancy, or women who are breast-feeding.
3.In case of known or suspected acute or chronic types of porphyria.
4. In case of renal insufficiency (serum creatinine is more than 2.0mg/dl)
5. In case of hepatic insufficiency (serum gamma glutamyl transpeptidase >100IU/l, ptotronbin time <60% or total bilirubin >3mg/dl)
6. In case of other conditions considered as undesirable for entry in this clinical trial.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Ozawa
Organization Osaka City University
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address Asahi 1-4-3,abeno,Osaka
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka city University
Division name Department of Plastic and Reconstructive Surgery
Zip code
Address
TEL
Homepage URL
Email ozawa@med.osaka-cu.ac.jp

Sponsor
Institute Department of Plastic and Reconstructive Surgery, Osaka City University, Graduate 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

Other administrative information
Date of disclosure of the study information
2012 Year 03 Month 21 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 Open public recruiting
Date of protocol fixation
2012 Year 03 Month 21 Day
Date of IRB
Anticipated trial start date
2012 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 03 Month 18 Day
Last modified on
2012 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008884

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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