Clinical Drug Experience Knowledgebase

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