UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004329 |
|---|---|
| Receipt number | R000005185 |
| Scientific Title | Photodynamic therapy with topical 5-aminolevulinic acid for the treatment of skin cancers |
| Date of disclosure of the study information | 2010/10/06 |
| Last modified on | 2012/04/06 16:25:08 |
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Basic information
Public title
Photodynamic therapy with topical 5-aminolevulinic acid for the treatment of skin cancers
Acronym
Photodynamic therapy with topical 5-aminolevulinic acid for the treatment of skin cancers
Scientific Title
Photodynamic therapy with topical 5-aminolevulinic acid for the treatment of skin cancers
Scientific Title:Acronym
Photodynamic therapy with topical 5-aminolevulinic acid for the treatment of skin cancers
Region
| Japan |
Condition
Condition
skin cancers
Classification by specialty
| Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy of therapy with 5-aminolevulinic acid in patients with skin cancers
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy of therapy with 5-aminolevulinic acid in patients with skin cancers
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
Historical
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
20% 5-aminolevulinic acid in emulsifying ointment will be applied to the surface of skin cancer. The treatment area will be covered with an adhesive dressing plus a light opaque dressing for 4 hours. And the lesions will be irradiated with Dye laser.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 are considered unsuitable for this study by the investigator
Target sample size
10
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 | Toshiyuki Ozawa |
Organization
Osaka City University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
Asahi 1-4-3, Abeno, Osaka
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
| 2010 | Year | 10 | Month | 06 | 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
| 2010 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 10 | 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
| 2010 | Year | 10 | Month | 05 | Day |
Last modified on
| 2012 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005185
