None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Healthy males or females aged 20 to 65 years who do not meet any exclusion criteria Clinically diagnosed with pigmentation phenotypes with an expected improvement from laser treatment Available for follow-up throughout the study period Able to understand the study, provide written informed consent during the screening visit, and comply with study procedures
Exclusion criteria
Exclusion criteria: Exclusion Criteria: Individuals with infectious skin diseases Individuals with a history of skin diseases at the treatment area other than decreased elasticity, wrinkles, or hyperpigmentation Individuals with keloid tendencies or collagen/elastin fiber disorders Individuals with psychiatric disorders Individuals at risk of bleeding due to anticoagulant medication Individuals with allergies to local anesthetics (e.g., lidocaine) Pregnant or breastfeeding women, or women who may become pregnant Individuals with acute or chronic medical conditions that may affect the outcome of the study Individuals who have undergone filler injections or fat grafting procedures within the last 3 months Individuals who have used topical steroids for more than 2 weeks for the treatment of skin conditions Individuals who have used systemic anti-inflammatory drugs (e.g., corticosteroids) within 4 weeks prior to screening Individuals who have used topical steroids or anti-inflammatory agents within 3 months prior to screening Individuals who have used topical retinol within 4 weeks prior to screening Individuals with a history of cosmetic laser treatments, chemical peels, or plastic surgery on the face within 6 months prior to screening Individuals deemed unsuitable for the clinical trial by the investigator Individuals who are unable to understand the purpose of the study or comply with study requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global Aesthetic Improvement Scale (GAIS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective skin improvement via Mexameter, Corneometer, Elastometer, and Skin Cube measurements;Clinical photography and image analysis using Mark Vu™ for hemi-MASI and Modified Griffith Scale scoring;Subjective satisfaction surveys from participants | — |
Countries
Korea, Republic of
Contacts
Yonsei University Yongin Severance Hospital