UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058463 |
|---|---|
| Receipt number | R000066850 |
| Scientific Title | Evaluation of Post-Treatment Benefits of Formulation Use Containing Active Ingredient of Quasi-drug Following Pico Laser Toning for Melasma |
| Date of disclosure of the study information | 2025/07/18 |
| Last modified on | 2025/07/14 17:51:49 |
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Basic information
Public title
Evaluation of Post-Treatment Benefits of Formulation Use Containing Active Ingredient of Quasi-drug Following Pico Laser Toning for Melasma
Acronym
Evaluation of Post-Treatment Benefits of Formulation Use Containing Active Ingredient of Quasi-drug Following Pico Laser Toning for Melasma
Scientific Title
Evaluation of Post-Treatment Benefits of Formulation Use Containing Active Ingredient of Quasi-drug Following Pico Laser Toning for Melasma
Scientific Title:Acronym
Evaluation of Post-Treatment Benefits of Formulation Use Containing Active Ingredient of Quasi-drug Following Pico Laser Toning for Melasma
Region
| Japan |
Condition
Condition
Melasma
Classification by specialty
| Dermatology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety Assessment
The incidence of adverse effects will be compared between the application sites of the formulation containing active ingredient of quasi-drug and those of the placebo formulation.
Efficacy Assessment
The efficacy of the formulation containing active ingredient of quasi-drug against melasma will be compared with that of the placebo formulation at the application sites using visual assessment, photographic evaluation, instrumental measurements, and participant questionnaires. Furthermore, gene expression changes in both application sites will be analyzed to identify genes involved in melasma improvement. Differences in gene expression profiles between the formulations will also be examined to elucidate the mechanism of action of active ingredient of quasi-drug.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
At weeks 0, 6, and 12 after the initiation of formulation use, dermatological examinations will be conducted by dermatologists.
The incidence of adverse effects will be compared between the sites treated with the formulation containing active ingredient of quasi-drug and those treated with the placebo formulation.
Key secondary outcomes
At weeks 0, 6, and 12 following the initiation of formulation use, visual assessments by dermatologists, photography, instrumental measurements, and participant questionnaires will be conducted.
Based on these evaluations, the efficacy of the formulation containing active ingredient of quasi-drug will be compared with that of the placebo formulation in the treatment of melasma.
In addition, skin samples will be collected from both application sites for gene expression analysis.
This analysis aims to identify genes involved in the improvement of melasma and to elucidate the mechanism of action of active ingredient of quasi-drug.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Pico Laser Toning and quasi-drug treatment group
Interventions/Control_2
Pico Laser Toning and placebo treatment group
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 an explanation of this study, have understood the information, and have voluntarily consented to participate in the research (i.e., provided informed consent).
2.Healthy Japanese women diagnosed with melasma on both the left and right cheeks in the study titled " Analysis of Gene Expression Characteristics in Melasma."
3.Individuals capable of completing consent forms and related documents.
4.Individuals able to visit the designated facility on scheduled measurement days.
5.Individuals who agree to the use of their facial photographs in research dissemination media such as product brochures, academic papers, and websites (with measures taken to minimize personal identification, such as obscuring eyes or limiting the facial area shown).
6.Individuals interested in laser treatment for facial melasma.
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 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 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
24
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
1040061
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（東京都）
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
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 | 06 | Month | 11 | Day |
Date of IRB
| 2025 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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=R000066850
