Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058462) titled 'Analysis of Gene Expression Characteristics in Melasma' on July 18.

Study Type: Observational

Primary Sponsor: Institute - POLA Chemical Industries, Inc.

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

Objective: 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

Eligibility: Age-lower limit - 30 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 Size - 60

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066849

Disclaimer: Curated by HT Syndication.