UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007523 |
|---|---|
| Receipt number | 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 11:16:55 |
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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
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
ozawa@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Osaka City University, Graduate 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008884
