Metabolism Enhancement by Laser Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percent Body Fat (%)
研究概览
简要总结
This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile.
详细描述
The current research project aims to investigate the effects of large-area fractional laser treatment (LAFLT) on body weight, metabolism, and body composition. Prior research suggests that treating large skin areas with fractional laser therapy may stimulate metabolism and promote weight loss. The MIRIA laser, an FDA-approved fractional laser, is widely used for skin aging, acne scarring, and wrinkle reduction and will be used to evaluate these potential metabolic effects.
Subjects aged 18-60 with a BMI of 25-30 will undergo three fractional laser treatments on the abdomen and thighs over 36 weeks, with sessions every four weeks. The study includes six total visits, incorporating photography, non-invasive imaging, x-rays, blood draws, and two optional biopsies.
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
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18- 60 years of age;
- •BMI between 25.0 and 30 kg/m2;
- •Subjects must be in good general health, based on answers provided during the screening visit;
- •Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol.
- •Females of childbearing potential must be willing and able to use a medically highly effective form of birth control during the entire study.
排除标准
- •Participation in another investigational drug or device clinical trial in the past 30 days;
- •Currently pregnant or pregnancy within the past 6 months or currently breastfeeding;
- •Have a history of drug or alcohol abuse in the past 3 years 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);
- •Planning or currently participating in a weight loss program;
- •Plan to change daily diet or level of physical activity;
- •Intake of medication that may affect body weight such as GLP-1 receptor agonists, amitriptyline, bupropion, thyroid medications, etc.;
- •History of cancer which required lymph node biopsy or dissection;
- •Weight loss or gain of 10 kg or more in the past 6 months;
- •History of diabetes mellitus or cardiac disease;
- •Intake of hormone replacement therapy (HRT) in the last 6 months;
- •Infection, surgery, or history of trauma or laser treatment to the treatment area in the past 6 months;
- •Presence of any skin disease on the abdomen or thighs;
- •Have birthmarks, tattoos, scars, or any other disfiguration of the skin in the abdomen or thighs;
- •Presence of sunburn or tan in the abdomen or thighs;
- •Use of any topical application of retinoids in the past 6 weeks on the abdomen or thighs or intake of systemic retinoids in the past 6 months;
- •Use of any prescription topical medication, such as corticosteroids or hydroquinone on the abdomen or thighs in the past 6 weeks;
- •History of keloid formation or hypertrophic scarring;
- •History of bariatric surgery or other major weight-loss procedures;
- •History of abdominal liposuction, abdominoplasty or CoolSculpting;
- •Known allergy to lidocaine or other local anesthetics;
- •The investigator believes that the subject is an unsuitable candidate to participate in the study, receive laser treatment, or would be placed at risk by participating in the study.
研究组 & 干预措施
Fractional Laser treatment
Large Area Fractional Laser treatments to the abdomen and thighs using the MIRIA laser.
干预措施: Fractional Laser (Device)
结局指标
主要结局
Percent Body Fat (%)
时间窗: Week 1, 12, 24
The percent body fat will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).
Body Mass Index (BMI) (kg/m²)
时间窗: Week 0, 4, 8, 12, 24
BMI will be calculated using the formula: weight (kg) / \[height (m)\]². Height will be measured at the baseline visit and body weight will be measured at each of the following visits.
Waist circumference (cm)
时间窗: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Hip circumference (cm)
时间窗: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Arm circumference (cm)
时间窗: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Total Lean Body Mass (kg)
时间窗: Week 1, 12, 24
The total lean body mass will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).
次要结局
- Histamine(Week 0, 4, 8, 12, 24)
- Oxytocin(Week 0, 4, 8, 12, 24)
- Serum Interleukin-6 (IL-6)(Week 0, 4, 8, 12, 24)
- Complete Blood Count (CBC)(Week 0, 4, 8, 12, 24)
- Comprehensive Metabolic Panel (CMP)(Week 0, 4, 8, 12, 24)
- Lipid Panel(Week 0, 4, 8, 12, 24)
- HbA1c(Week 0, 4, 8, 12, 24)
- C-Reactive Protein (CRP)(Week 0, 4, 8, 12, 24)
- Erythrocyte Sedimentation Rate (ESR)(Week 0, 4, 8, 12, 24)
- Cortisol(Week 0, 4, 8, 12, 24)
- Creatine Phosphokinase (CPK)(Week 0, 4, 8, 12, 24)
- Serum Norepinephrine(Week 0, 4, 8, 12, 24)
- Indirect Calorimetry(Week 0,12, 24)
- Skin Biopsy (Optional)(Week 1, 12)
- Skin Elasticity(Week 0, 4, 8, 12, 24)
- Skin Thickness(Week 0, 4, 8, 12, 24)
- Hydration Status (%)(Week 0, 12)
- VAS Pain Score(Week 1, 4, 8)
- Total Body Bone Mineral Density (g/cm²)(Week 1, 12, 24)
研究者
Maria Alora
Director, MGH Clinical Unit for Research Trials in Skin
Massachusetts General Hospital