Clinical trial NCT06899958: Metabolism Enhancement by Laser Therapy
Official title: Metabolism Enhancement by Laser Therapy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolism Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2025-03-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 18- 60 years of age;
2. BMI between 25.0 and 30 kg/m2;
3. Subjects must be in good general health, based on answers provided during the screening visit;
4. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol.
5. 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:

1. Participation in another investigational drug or device clinical trial in the past 30 days;
2. Currently pregnant or pregnancy within the past 6 months or currently breastfeeding;
3. 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);
4. Planning or currently participating in a weight loss program;
5. Plan to change daily diet or level of physical activity;
6. Intake of medication that may affect body weight such as GLP-1 receptor agonists, amitriptyline, bupropion, thyroid medications, etc.;
7. History of cancer which required lymph node biopsy or dissection;
8. Weight loss or gain of 10 kg or more in the past 6 months;
9. History of diabetes mellitus or cardiac disease;
10. Intake of hormone replacement therapy (HRT) in the last 6 months;
11. Infection, surgery, or history of trauma or laser treatment to the treatment area in the past 6 months;
12. Presence of any skin disease on the abdomen or thighs;
13. Have birthmarks, tattoos, scars, or any other disfiguration of the skin in the abdomen or thighs;
14. Presence of sunburn or tan in the abdomen or thighs;
15. 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;
16. Use of any prescription topical medication, such as corticosteroids or hydroquinone on the abdomen or thighs in the past 6 weeks;
17. History of keloid formation or hypertrophic scarring;
18. History of bariatric surgery or other major weight-loss procedures;
19. History of abdominal liposuction, abdominoplasty or CoolSculpting;
20. Known allergy to lidocaine or other local anesthetics;
21. 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.

Primary outcomes:
measure: Percent Body Fat (%)
timeFrame: Week 1, 12, 24
measure: Body Mass Index (BMI) (kg/m²)
timeFrame: Week 0, 4, 8, 12, 24
measure: Waist circumference (cm)
timeFrame: Week 0, 4, 8, 12, 24
measure: Hip circumference (cm)
timeFrame: Week 0, 4, 8, 12, 24
measure: Arm circumference (cm)
timeFrame: Week 0, 4, 8, 12, 24
measure: Total Lean Body Mass (kg)
timeFrame: Week 1, 12, 24
Secondary outcomes:
measure: Complete Blood Count (CBC)
timeFrame: Week 0, 4, 8, 12, 24
measure: Comprehensive Metabolic Panel (CMP)
timeFrame: Week 0, 4, 8, 12, 24
measure: Lipid Panel
timeFrame: Week 0, 4, 8, 12, 24
measure: HbA1c
timeFrame: Week 0, 4, 8, 12, 24
measure: C-Reactive Protein (CRP)
timeFrame: Week 0, 4, 8, 12, 24
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: Week 0, 4, 8, 12, 24
measure: Histamine
timeFrame: Week 0, 4, 8, 12, 24
measure: Cortisol
timeFrame: Week 0, 4, 8, 12, 24
measure: Oxytocin
timeFrame: Week 0, 4, 8, 12, 24
measure: Creatine Phosphokinase (CPK)
timeFrame: Week 0, 4, 8, 12, 24
measure: Serum Interleukin-6 (IL-6)
timeFrame: Week 0, 4, 8, 12, 24
measure: Serum Norepinephrine
timeFrame: Week 0, 4, 8, 12, 24
measure: Indirect Calorimetry
timeFrame: Week 0,12, 24
measure: Skin Biopsy (Optional)
timeFrame: Week 1, 12
measure: Skin Elasticity
timeFrame: Week 0, 4, 8, 12, 24
measure: Skin Thickness
timeFrame: Week 0, 4, 8, 12, 24
measure: Hydration Status (%)
timeFrame: Week 0, 12
measure: VAS Pain Score
timeFrame: Week 1, 4, 8
measure: Total Body Bone Mineral Density (g/cm²)
timeFrame: Week 1, 12, 24
Other outcomes:
Locations:
city: Boston
country: United States
facility: MGH Clinical Unit for Research Trials & Outcomes in Skin
state: Massachusetts
Study officials:
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