UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052132 |
|---|---|
| Receipt number | R000059337 |
| Scientific Title | Research on improvement mechanism of solar lentigo |
| Date of disclosure of the study information | 2023/09/22 |
| Last modified on | 2023/11/08 16:15:05 |
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Basic information
Public title
Research on improvement mechanism of solar lentigo
Acronym
Research on improvement mechanism of solar lentigo
Scientific Title
Research on improvement mechanism of solar lentigo
Scientific Title:Acronym
Research on improvement mechanism of solar lentigo
Region
| Japan |
Condition
Condition
Solar lentigo
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we will apply cosmetic products or medical treatment that are expected to have an improvement effect to research subjects with solar lentigo, and collect samples from their skin (including stratum corneum) before and after the treatments. The aim is to elucidate the mechanism that is related to improvement of solar lentigo by analyzing the gene expression of the samples.
Basic objectives2
Others
Basic objectives -Others
Elucidation of the mechanism of solar lentigo improvement
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
# Analysis of relationship between skin color change and gene expression at each measurement point.
# Differences in gene expression changes among treatments.
Key secondary outcomes
# Differences in gene expression between groups with and without improvement of solar lentigo.
# Analysis of relationship between gene expression and hyperpigmentation except solar lentigo in the medical treatment group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Device,equipment | Other |
Interventions/Control_1
Test product A group
Interventions/Control_2
Test product B group
Interventions/Control_3
Test product C group
Interventions/Control_4
Test product D group
Interventions/Control_5
Test product E group
Interventions/Control_6
Test product F group
Interventions/Control_7
Medical treatment group
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Persons who have received an explanation of this study, understand it, and agree to participate in the study of their own free will (persons who have given their informed consent)
(2) Persons who are aware that they have solar lentigo
(3) Persons who are able to fill out the consent form and other documents
(4) Persons who are able to come to the designated facility on the day of the study
Key exclusion criteria
(1) Persons who have skin symptoms such as external wound, rosacea, eczema, etc. at the evaluation site
(2) Persons who regularly go or plan to go to tanning salons during the study period
(3) Persons who are likely to be exposed to significant sunlight during the study period (e.g., Daily exercise during the daytime)
(4) Persons with a history of atopic dermatitis
(5) Persons who are expected to suffer from severe hay fever* during the study period (*level requiring a hospital visit)
(6) Persons with a history of severe hepatic disorder, renal disorder, or myocardial infarction
(7) Persons with severe anemia
(8) Persons with a keloid constitution (scars easily become red and swollen and are difficult to heal)
(9) Persons who have diabetes mellitus
(10) Persons who are taking antithrombotic medicines
(11) Pregnant, lactating mothers and those who plan to become pregnant during the study period
(12) Persons who are currently participating in other clinical studies or who plan to participate in other clinical studies during the study period
(13) Persons with cold symptoms or fever of 37.5 degrees Celsius or higher (Exclusion criteria only on the day of the visit; temperature will be checked at the reception desk)
(14) Persons who are taking or have taken gold preparations (Shiosol, Auranofin,etc.) for rheumatism, etc
(15) Persons who have gold threads or metal plates, etc. inserted in the treatment area (face)
(16) Persons who have skin-colored tattoos on the treatment area (face)
(17) Persons who have undergone cosmetic surgery in the past and are currently in downtime
(18) Persons who have experienced severe pain, erythema, or scarring after undergoing cosmetic surgery in the past
(19) Persons who have experienced rashes or skin problems due to hair dye
(20) Others whom the doctors involved in the research deem inappropriate
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoko |
| Middle name | |
| Last name | Funasaka |
Organization
Jieikai Byoin
Division name
Dermatology
Zip code
123-0843
Address
2-8-6, Nishi-Arai-Sakaecho, Adachi-Ku
TEL
03-3889-1111
funasaka@nms.ac.jp
Public contact
Name of contact person
| 1st name | Fumiya |
| Middle name | |
| Last name | Yamaji |
Organization
POLA Chemical Industries,Inc.
Division name
Frontier Research Center
Zip code
244-0812
Address
560 Kashio-cho, Totsuka-ku, Yokohama
TEL
045-826-7232
Homepage URL
f-yamaji@pola.co.jp
Sponsor or person
Institute
Jieikai Byoin
Institute
Department
Personal name
Funding Source
Organization
POLA Chemical Industries Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
POLA Chemical Industries Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yamauchi Clinic IRB
Address
1-15-19, Jiyugaoka, Meguro Ku, Tokyo To, Japan
Tel
03-5575-5862
c-irb_ug@neues.co.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
医療法人社団 浩央会 東小金井さくらクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 09 | Month | 22 | 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
120
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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 09 | Month | 06 | Day |
Last modified on
| 2023 | Year | 11 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059337
