UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059491 |
|---|---|
| Receipt number | R000068036 |
| Scientific Title | Study on Gene Expression Characteristics in Skin Areas Suspected of Having Solar Lentigines or Melasma |
| Date of disclosure of the study information | 2025/10/21 |
| Last modified on | 2025/10/21 17:01:25 |
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Basic information
Public title
Study on Gene Expression Characteristics in Skin Areas Suspected of Having Solar Lentigines or Melasma
Acronym
Gene Expression Analysis Study of Skin Areas Suspected of Solar Lentigines or Melasma
Scientific Title
Study on Gene Expression Characteristics in Skin Areas Suspected of Having Solar Lentigines or Melasma
Scientific Title:Acronym
Gene Expression Analysis Study of Skin Areas Suspected of Solar Lentigines or Melasma
Region
| Japan |
Condition
Condition
Solar Lentigines, Melasma
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Establishment of a Novel Classification of Pigmentation Spots and Elucidation of Their Underlying Causes Based on Gene Expression Profiling in Skin Areas Suspected of Solar Lentigines or Melasma
Basic objectives2
Others
Basic objectives -Others
Correlation Analysis Between Questionnaire Data and Information Obtained During Clinical Examinations at Research Institutions (Including Skin Information, Facial Images, and Measured Numerical Data) and Comprehensive Gene Expression Analysis Results
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive Gene Expression Analysis of Pigmented and Normal Skin Areas
Key secondary outcomes
Correlation Analysis Between Questionnaire Data and Information Obtained During Clinical Examinations at Research Institutions (Including Skin Information, Facial Images, and Measured Numerical Data) and Comprehensive Gene Expression Analysis Results
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with pigmentation spots (such as spots or melasma) at ALOOP CLINIC & LAB, operated by the General Incorporated Association Astronauts
Individuals who have received an explanation of this study, fully understood its contents, and voluntarily agreed to participate by providing informed consent
Healthy individuals aged 18 years or older
Individuals capable of completing, entering, or electronically signing consent forms and related documents
Key exclusion criteria
Individuals with a history of severe hepatic disorder, renal disorder, or myocardial infarction
Individuals with severe anemia
Individuals with a keloid predisposition (those whose scars tend to become raised and red, resembling a worm-like swelling, and heal poorly)
Individuals with diabetes mellitus
Individuals taking medications that affect skin sampling, such as antiplatelet agents (e.g., aspirin) or anticoagulants
Individuals with bleeding or hemostatic disorders
Individuals with a history of serious blood-borne infections, such as HIV, hepatitis B, hepatitis C, or syphilis
Individuals who have traveled within the past 14 days to areas where infectious diseases are prevalent (as designated by the Ministry of Foreign Affairs' Infectious Disease Risk Information)
Individuals with cold symptoms or a fever of 37.5C or higher
Any other individuals deemed inappropriate for participation by the principal investigator of the research institution
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yamasaki |
Organization
General Incorporated Association Astronauts- ALOOP CLINIC & LAB
Division name
General Incorporated Association Astronauts- ALOOP CLINIC & LAB
Zip code
104-0061
Address
1-7-7 Ginza, Chuo-ku, Tokyo - POLA Ginza Building
TEL
0120-506-182
k-yamasaki@aloop.clinic
Public contact
Name of contact person
| 1st name | Taku |
| Middle name | |
| Last name | Nishijo |
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
t-nishijo@pola.co.jp
Sponsor or person
Institute
POLA Chemical Industries, Inc.
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
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee.
Address
Hakutyo Build. 2F,2-1-2 Shinjuku,Shinjuku-ku,Tokyo
Tel
03-6273-2214
ethics_board@drc-web.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 10 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 09 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comprehensive Gene Expression Analysis of Pigmented and Normal Skin Areas
Management information
Registered date
| 2025 | Year | 10 | Month | 21 | Day |
Last modified on
| 2025 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068036
