UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004564 |
|---|---|
| Receipt number | R000005453 |
| Scientific Title | Effects of long term application of sunscreen to actinic keratosis; prospective case control study |
| Date of disclosure of the study information | 2010/11/21 |
| Last modified on | 2022/11/25 12:44:19 |
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Basic information
Public title
Effects of long term application of sunscreen to actinic keratosis; prospective case control study
Acronym
Effects of long term application of sunscreen to actinic keratosis: prospective case control study
Scientific Title
Effects of long term application of sunscreen to actinic keratosis; prospective case control study
Scientific Title:Acronym
Effects of long term application of sunscreen to actinic keratosis: prospective case control study
Region
| Japan |
Condition
Condition
actinic keratosis
Classification by specialty
| Dermatology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Efficacy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
the number of actinic keratosis
Key secondary outcomes
the number of solar lentigo, wrinkle
the histological change of actinic keratosis
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
| Other |
Interventions/Control_1
application of sunscreen (SPF30, PA+++) for 3 years
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
existence of actinic keratosis on the face, ears, hands and forearms
Key exclusion criteria
squamous cell carcinoma, basal cell carcinoma, severe actinic keratosis(AK3)
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Yamamoto |
Organization
Wakayama Medical University
Division name
dermatology
Zip code
641-8509
Address
811-1 kimiidera wakayama city wakayama, Japan
TEL
073-447-2300
yukiy@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kayo |
| Middle name | |
| Last name | Kunimoto |
Organization
Wakayama Medical University
Division name
dermatology
Zip code
641-8509
Address
811-1 kimiidera wakayama city wakayama, Japan
TEL
073-447-2300
Homepage URL
k-jigen@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
Funding Source
Organization
Wakayama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kose
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Wakayama Medical University
Address
811-1 kimiidera wakayama city wakayama, Japan
Tel
073-447-2300
wa-rinri@wakayama-med.ac.jp
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
和歌山県立医科大学付属病院
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | 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
Completed
Date of protocol fixation
| 2010 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 06 | Month | 30 | Day |
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 16 | Day |
Last modified on
| 2022 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005453
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
