Melasma
Conditions
Interventions
Pico Laser Toning and quasi-drug treatment group
Pico Laser Toning and placebo treatment group
Sponsors
POLA Chemical Industries, Inc.
ALOOP CLINIC&
LAB
Eligibility
Sex/Gender
Female
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactKeitaro Okada
POLA Chemical Industries, Inc. Frontier Research Center
Outcome results
None listed