A Comparative Clinical Study to Assess Pain Score and Wound Healing Following Fractional Ablation With a Difference Frequency Generation (DFG) Laser and Carbon Dioxide (CO2) Laser
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- Visual Analog Scale (VAS) pain score
研究概览
简要总结
This research study aims assess whether the Difference Frequency Generation (DFG) laser could be a better alternative to the CO2 laser in terms of reduced side effects and patient downtime.
详细描述
The primary goal of this study is to compare the pain score and wound healing time in healthy subjects undergoing low fluence fractional ablation using the DFG and CO2 lasers. The secondary objective involves assessing the impact of each laser on dermal vasculature using an Optical Coherence Tomography (OCT) imaging system.
Participants will be treated with the DFG and CO2 laser to the upper thighs. Photography, pain scores, and OCT imaging will be recorded over the course of the study visits.
The investigators plan to enroll 23 healthy subjects to complete the study. Subjects must be equal to greater than 18 years old and may be any gender or Fitzpatrick skin type.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
- •Subjects must be in good general health, based on answers provided during the screening visit;
- •Subjects must be able to read and understand English.
- •Subjects must be above the age of
- •Subjects must have no history of skin conditions that affect the integrity of the skin barrier.
排除标准
- •Are pregnant or lactating;
- •Have a history of drug or alcohol abuse or have reported habitual alcohol intake greater than 2 standard drinks per day [e.g., 2 beers, 2 glasses of wine, or 2 mixed drinks];
- •Are smoking or have a history of smoking;
- •Presence of eczema, psoriasis, skin wounds or ulcers, or any other skin disease on the thighs;
- •Have birth marks, tattoos, scars, or any other disfiguration of the skin in the skin area of interest;
- •Presence of sunburn or tan in the treatment area;
- •Use of any topical application of retinoids in the area of interest or systemic retinoids in the past 6 months;
- •Use of any prescription topical medication, such as corticosteroids or hydroquinone on the skin area of interest in the past 6 months;
- •History of blood-clotting abnormality;
- •History of keloid formation or hypertrophic scarring;
- •History of allergic reaction to local anesthesia, aluminum chloride, and/or glycerol;
- •Investigator, interfere with study evaluations or pose a risk to subject safety during the study;
- •Exhibits any clinical conditions or takes any medication which in the opinion of the investigator may interfere with the study or pose a risk to subject safety during the study;
- •Is not able to follow study protocol.
研究组 & 干预措施
Treatment
23 healthy subjects with treatment of the DFG and CO2 laser
干预措施: DFG Laser (Device)
Treatment
23 healthy subjects with treatment of the DFG and CO2 laser
干预措施: CO2 Laser (Device)
Treatment
23 healthy subjects with treatment of the DFG and CO2 laser
干预措施: Optical coherence tomography (OCT) (Device)
结局指标
主要结局
Visual Analog Scale (VAS) pain score
时间窗: 90 minutes
Subjects will report pain score using VAS for the CO2 and DFG laser treated areas at Visit 1. The VAS is a 10cm long scale with 0cm representing "no pain" and 10cm representing "worst possible pain".
Wound healing time
时间窗: 1 month
Wound healing of the laser treated areas will be assessed and compared via photography at each visit.
次要结局
- Vessel thickness via OCT imaging(1 month)
- Vessel density via OCT imaging(1 month)
- Vessel length via OCT imaging(1 month)
研究者
Dieter Manstein, MD
Principal Investigator
Massachusetts General Hospital