Efficacy and Safety of Picosecond, Neodymium-doped Yttrium Aluminum Garnet Laser Therapy Using 1,064 nm and 595 nm
- Conditions
- Melasma
- Interventions
- Drug: Neoquine Cream 2%Device: PICO+4
- Registration Number
- NCT03040089
- Lead Sponsor
- LUTRONIC Corporation
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 40
-
Females between the ages of 19 and 74
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Has Fitzpatrick Skin Type III-V
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Diagnosed with moderate to severe (GSS ≧ 2) melasma lesions
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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
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(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.
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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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2% hydroquinone cream Neoquine Cream 2% Only Neoquine Cream 2% (2% hydroquinone cream) for melasma picosecond laser & 2% hydroquinone cream PICO+4 PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma picosecond laser & 2% hydroquinone cream Neoquine Cream 2% PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Relative skin lightness using the colorimeter(RL*I) Baseline, 1 week, 4 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 mMASI (modified Melasma Area Severity Index) evaluation Baseline, 1 week, 4 weeks, 8 weeks, and 12 weeks after the final treatment