Metabolism Enhancement by Laser Therapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Percent Body Fat (%)
Study Overview
Brief Summary
This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Fractional Laser treatment
Large Area Fractional Laser treatments to the abdomen and thighs using the MIRIA laser.
Intervention: Fractional Laser (Device)
Outcomes
Primary Outcomes
Percent Body Fat (%)
Time Frame: 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)
Time Frame: 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)
Time Frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Hip circumference (cm)
Time Frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Arm circumference (cm)
Time Frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Total Lean Body Mass (kg)
Time Frame: 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).
Secondary Outcomes
- 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)
Investigators
Maria Alora
Director, MGH Clinical Unit for Research Trials in Skin
Massachusetts General Hospital