Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058463) titled 'Evaluation of Post-Treatment Benefits of Formulation Use Containing Active Ingredient of Quasi-drug Following Pico Laser Toning for Melasma' on July 18.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - POLA Chemical Industries, Inc.

Condition: Condition - Melasma Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - Pico Laser Toning and quasi-drug treatment group Interventions/Control_2 - Pico Laser Toning and placebo treatment group

Eligibility: Age-lower limit - 30 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 Size - 24

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066850

Disclaimer: Curated by HT Syndication.