Melasma
Conditions
Brief 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.
Interventions
DEVICEPICO+4
picosecond, neodymium-doped yttrium aluminum garnet laser
DRUGNeoquine Cream 2%
2% hydroquinone cream
Sponsors
LUTRONIC Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 74 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success rate of treatment according to RL*I | Baseline, 1 week after final treatment | The success rate is determined by the change rate (%) of the relative lightness measured before the treatment (day of screening) and 1 week after the final treatment. |
Secondary
| Measure | Time frame |
|---|---|
| Relative skin lightness using the colorimeter(RL*I) | Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment |
| mMASI (modified Melasma Area Severity Index) evaluation | Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment |
| Subject satisfaction (5-point scale questionnaires on subject's satisfaction) | 1 week and 12 weeks after the final treatment |
Outcome results
None listed