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


Email



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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name