NCT03040089已完成不适用
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- Success rate of treatment according to RL*I
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
picosecond laser & 2% hydroquinone cream
Experimental
PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma
干预措施: PICO+4 (Device)
picosecond laser & 2% hydroquinone cream
Experimental
PICO+4 laser system and Neoquine Cream 2% (2% hydroquinone cream) for melasma
干预措施: Neoquine Cream 2% (Drug)
2% hydroquinone cream
Sham Comparator
Only Neoquine Cream 2% (2% hydroquinone cream) for melasma
干预措施: Neoquine Cream 2% (Drug)
结局指标
主要结局
Success rate of treatment according to RL*I
时间窗: 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.
次要结局
- 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)
- Relative skin lightness using the colorimeter(RL*I)(Baseline, 1 week, 4 weeks, and 12 weeks after the final treatment)
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