NCT04539561Unknown不适用
Evaluation of the Efficacy and Safety of PiQo4 for the Treatment of Hand Pigmentation Using 1064nm PSL and 532nm PSL
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Hands pigmentation change assessed by investigator
研究概览
简要总结
A total of 20 healthy subjects at a single site, aged 21-70 years old with congenital or acquired challenging/resistant, age/sun-related flat and benign hand pigmentation who wish to improve their skin appearance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Female/Male.
- •Age= 21-70 (Adults).
- •Fitzpatrick skin phototype = I-V
- •Congenital or acquired benign pigmentation on hands.
- •Presence of at least three (3) lesions with similar pigmentation intensity in the treatment area in diameters larger than 2 mm.
- •Able to read, understand and provide written Informed Consent.
- •Able and willing to comply with the treatment/follow-up schedule and requirements.
- •Women of child-bearing potential are required to use a reliable method of birth control (such as an intrauterine device, birth control pills, condom with spermicidal, NuvaRing, partner with vasectomy, Implanon or other FDA-approved devices, or abstinence) during the course of the study.
排除标准
- •History of post inflammatory pigmentary disorders, particularly a tendency for hyper- or hypo-pigmentation.
- •Tanning (artificial or natural) 1 month prior first treatment and during the entire study duration including follow-up.
- •Excessive underlying vascular conditions (e.g. dense network of capillaries).
- •Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 3 months after completion of breastfeeding.
- •Prior skin laser, light or other energy device treatment in treated area within 6 months of initial treatment or during the course of the study.
- •Prior ablative resurfacing procedure in treated area with laser or other devices within 12 months of initial treatment or during the course of the study.
- •Prior treatment with medium-depth or deeper, chemical peels or dermabrasion in treated area within 3 months of initial treatment or during the course of the study.
- •Any other surgery in treated area within 9 months of initial treatment or during the course of the study.
- •Hypersensitive to light exposure or the use of photosensitive medication for which light exposure is contraindicated.
- •Multiple dysplastic nevi or suspicious pigmentation in area to be treated.
- •Presence of underlying tattoo in the treatment area.
- •Significant concurrent illness (e.g. uncontrolled diabetes) or any disease state that in the opinion of the Investigator would interfere with the treatment or healing process.
研究组 & 干预措施
Pigmentation
Experimental
Treatment of Hand Pigmentation Using PiQo4 Laser System
干预措施: PiQo4 Laser System (Device)
结局指标
主要结局
Hands pigmentation change assessed by investigator
时间窗: 1 month follow up
Hands pigmentation change assessed by investigator at the 1 month follow up using the 5-point Pigment Improvement Score where score of between 0 and 4 will be assigned (0- No improvement in pigmentation, 1- Trace to mild improvement of some lesions, 2- Moderate response: some lesions lighter, 3- Good response: most lesions much lighter and 4- Excellent response- Most or all lesions much lighter or gone.
次要结局
未报告次要终点
研究者
研究点 (1)
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