Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Laser Therapy Using 1,064 nm and 595 nm on Patients With Melasma: A Prospective, Multi-center, Split Face, 2% Hydroquinone Cream-controlled Clinical Trial

Conditions
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Melasma

Intervention / Treatment
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* Device: PICO+4
* Drug: Neoquine Cream 2%


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: picosecond laser & 2% hydroquinone cream<br>PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma | Device: PICO+4<br>* picosecond, neodymium-doped yttrium aluminum garnet laser<br>Drug: Neoquine Cream 2%<br>* 2% hydroquinone cream<br>|
| Sham Comparator: 2% hydroquinone cream<br>Only Neoquine Cream 2% (2% hydroquinone cream) for melasma | Drug: Neoquine Cream 2%<br>* 2% hydroquinone cream<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of treatment according to RL*I | 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. | Baseline, 1 week after final treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |