UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058462 |
|---|---|
| Receipt number | R000066849 |
| Scientific Title | Analysis of Gene Expression Characteristics in Melasma |
| Date of disclosure of the study information | 2025/07/18 |
| Last modified on | 2025/07/14 17:20:31 |
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Basic information
Public title
Analysis of Gene Expression Characteristics in Melasma
Acronym
Analysis of Gene Expression Characteristics in Melasma
Scientific Title
Analysis of Gene Expression Characteristics in Melasma
Scientific Title:Acronym
Analysis of Gene Expression Characteristics in Melasma
Region
| Japan |
Condition
Condition
Melasma
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Skin samples will be collected from both hyperpigmented and non-hyperpigmented areas in Japanese women with melasma.
Comprehensive gene expression analysis will be performed on the collected samples to elucidate the gene expression characteristics specific to the hyperpigmented areas of melasma.
Basic objectives2
Others
Basic objectives -Others
Gene Expression Profiling
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin samples will be collected from both hyperpigmented and non-hyperpigmented sites, and comprehensive gene expression analysis will be conducted.
Key secondary outcomes
Correlation analysis between photographic evaluation scores, instrument-based measurements, and comprehensive gene expression profiling 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
| 30 | years-old | <= |
Age-upper limit
| 54 | years-old | >= |
Gender
Female
Key inclusion criteria
1.Individuals who have received a full explanation of this study, understood the content, and voluntarily agreed to participate by providing written informed consent.
2.Healthy Japanese females aged 30 to 54 years who are aware of having melasma on both cheeks.
3.Individuals capable of completing the informed consent form and related documents.
4.Individuals who are able to visit the designated study site on the scheduled study dates.
5.Individuals who consent to the use of facial photographs in materials such as product brochures, academic publications, and online dissemination of research results, with appropriate measures taken to minimize personal identification (e.g., obscuring the eyes or limiting the visible facial area).
Key exclusion criteria
1.Individuals with skin conditions at the evaluation site that may affect the study results (e.g., trauma, acne, eczema)
2.Individuals who regularly use tanning salons or plan to do so during the study period.
3.Individuals who are likely to be exposed to excessive sunlight during the study period (e.g., outdoor sports over consecutive days).
4.Individuals with a history of atopic dermatitis.
5.Individuals with a history of allergic reactions to cosmetics.
6.Individuals with a history of serious liver or kidney disorders, or myocardial infarction.
7.Individuals with severe anemia.
8.Individuals with a keloid predisposition (e.g., those prone to raised, red, and persistent scarring).
9.Individuals diagnosed with diabetes.
10.Individuals taking medications that may affect skin sampling (e.g., antiplatelet agents such as aspirin, or anticoagulants).
11.Individuals with bleeding or coagulation disorders.
12.Individuals who are pregnant, planning to become pregnant, or currently breastfeeding.
13.Individuals undergoing hormone replacement therapy, including low-dose oral contraceptives.
14.Individuals using medications (e.g., vitamin C, tranexamic acid) or skincare products (e.g., hydroquinone) that may affect the study and are unable to discontinue their use during the study period.
15.Individuals who have undergone cosmetic dermatological procedures that may impact the study within one year prior to study initiation (since July 6, 2024), including laser treatments, intense pulsed light (IPL), radiofrequency, microneedling, or thread lifts.
16.Individuals who have participated in another clinical study within three months prior to study initiation (since April 6, 2025).
17.Individuals presenting with cold symptoms or a fever of 37.5 degrees celsius or higher.
18.Any other individuals deemed inappropriate for participation by the principal investigator.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kenshi |
| Middle name | |
| Last name | Yamasaki |
Organization
ALOOP CLINIC&LAB
Division name
Aesthetic Dermatology
Zip code
104-0061
Address
4th Floor, Pola Ginza Building, 1-7-7 Ginza, Chuo-ku, Tokyo
TEL
0120-506-182
k-yamasaki@aloop.clinic
Public contact
Name of contact person
| 1st name | Keitaro |
| Middle name | |
| Last name | Okada |
Organization
POLA Chemical Industries, Inc.
Division name
Frontier Research Center
Zip code
2440812
Address
560 Kashio-cho, Totsuka-ku, Yokohama
TEL
045-826-7232
Homepage URL
keitaro-okada@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
ALOOP CLINIC&LAB
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Brain Care Clinic Ethics Review Committee
Address
2nd Floor, Shiratori Building, 2-1-2 Shinjuku, Shinjuku-ku, Tokyo, Japan
Tel
03-4405-1899
info@brain-care.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
ALOOP CLINIC & LAB
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 07 | Month | 18 | 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
60
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
| 2025 | Year | 06 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Non-hyperpigmented areas will be used as background factors of participants for comparison, and gene expression information from skin tissues collected from hyperpigmented and non-hyperpigmented areas will be compared and analyzed to elucidate the gene expression characteristics specific to the hyperpigmented areas of melasma.
Management information
Registered date
| 2025 | Year | 07 | Month | 14 | Day |
Last modified on
| 2025 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066849
