efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet laser therapy using 1,064 nm and 595 nm

Conditions: Melasma

Summary: this is a prospective, multi-center, split-face, controlled clinical trial that aims to investigate the efficacy and safety of picosecond, neodymium-doped yttrium aluminum garnet laser laser therapy on patients with melasma, compared with 2% hydroquinone cream. the trial will be performed by two korean institutions on 45 subjects.


Eligibility criteria:
inclusion criteria: * females between the ages of 19 and 74 * has fitzpatrick skin type iii-v * diagnosed with moderate to severe (gss ≧ 2) melasma lesions * agreed to the prohibition of the use of local/systemic corticosteroids or retinoids and other local/systemic lightening medications, and willing to abide by such instructions * agreed to use the same facial skin care products during the clinical trial period (including the follow-up period), and willing to abide by such instructions * agreed to the daily use of an over spf 50 sunblock on their face during the clinical trial period (including the follow-up period), and willing to abide by such instructions * agreed to have their face photographed * (in case of fertile women) tested negative in the pregnancy test and agreed to use birth control contraceptives during the clinical trial period * oral contraceptives are forbidden as they may influence the results of the clinical study. * agreed not to undergo any other procedure on their face during their participation in the clinical trial * voluntarily agreed to sign the written consent form and willing to follow the instructions of the study protocol exclusion criteria: * participated in another medical device or medication clinical trial in the last 3 months, or planning to participate in another trial during this trial * received a cosmetic treatment such as laser, light therapy, or surgery in their facial area in the last 6 months, or have a history of filler treatments using collagen, hyaluronic acid, or any other material * diagnosed with incurable melisma * has a history of allergic reaction to local anesthesia * has a history of malignant tumors on their face * has skin lesions such as cuts, wounds, or injuries on their face * pregnant or breastfeeding * has an infection, dermatitis, or rash on their face * currently diagnosed with uncontrolled diabetes or a cardiac disorder such as resistant hypertension * currently diagnosed with anticoagulant disease or taking anticoagulants * has a history of keloid scarring, hypertrophic scarring, or abnormal would healing * has a history of immunodeficiency or intake of immunosuppressants * has a history of leukoplakia, eczema, or psoriasis * has a history of connective tissue diseases such as systemic lupus erythematosus or scleroderma * has a history of convulsive disorder caused by light * has a history of diseases irritated by heat on their face (e.g., herpes simplex or herpes zoster) * has a history of radiotherapy or anticancer chemotherapy on their face * has a history of hormonal therapy in the last 3 months (e.g., estrogen, progesterone, or oral contraceptive) * has a history of use of a lightening medication (hydroquinone, tranexamic acid), isotretinoid (or retinoid), light-sensitive medication, or steroids in the last 6 months * has excessive facial tanning * other subject assessed as inadequate for the clinical trial by the investigators