Metabolism Enhancement by Laser Therapy (MELT)

February 9, 2026 updated by: Maria Alora, Massachusetts General Hospital
This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MGH Clinical Unit for Research Trials & Outcomes in Skin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fractional Laser treatment
Large Area Fractional Laser treatments to the abdomen and thighs using the MIRIA laser.
Device: Fractional Laser
Three fractional laser treatments to the abdomen and thighs at 4 week intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 1, 12, 24
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.
Week 0, 4, 8, 12, 24
Waist circumference (cm)
Time Frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Week 0, 4, 8, 12, 24
Hip circumference (cm)
Time Frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Week 0, 4, 8, 12, 24
Arm circumference (cm)
Time Frame: Week 0, 4, 8, 12, 24
These measurements will be taken at each of the following visits
Week 0, 4, 8, 12, 24
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).
Week 1, 12, 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Blood Count (CBC)
Time Frame: Week 0, 4, 8, 12, 24
Measurement of red blood cell count, white blood cell count, hemoglobin, hematocrit, and platelet count via a blood draw.
Week 0, 4, 8, 12, 24
Comprehensive Metabolic Panel (CMP)
Time Frame: Week 0, 4, 8, 12, 24
Assessment of glucose, calcium, electrolyte and fluid balance (sodium, potassium, CO2, chloride), kidney function (BUN, creatinine), and liver function (albumin, total protein, ALP, ALT, AST, bilirubin) via a blood draw.
Week 0, 4, 8, 12, 24
Lipid Panel
Time Frame: Week 0, 4, 8, 12, 24
Measurement of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides via a blood draw.
Week 0, 4, 8, 12, 24
HbA1c
Time Frame: Week 0, 4, 8, 12, 24
Measurement of hemoglobin A1c via a blood draw.
Week 0, 4, 8, 12, 24
C-Reactive Protein (CRP)
Time Frame: Week 0, 4, 8, 12, 24
Measurement of CRP levels via a blood draw.
Week 0, 4, 8, 12, 24
Erythrocyte Sedimentation Rate (ESR)
Time Frame: Week 0, 4, 8, 12, 24
Assessment of the rate at which red blood cells sediment via a blood draw.
Week 0, 4, 8, 12, 24
Histamine
Time Frame: Week 0, 4, 8, 12, 24
Measurement of plasma histamine levels via a blood draw.
Week 0, 4, 8, 12, 24
Cortisol
Time Frame: Week 0, 4, 8, 12, 24
Measurement of serum cortisol levels via a blood draw.
Week 0, 4, 8, 12, 24
Oxytocin
Time Frame: Week 0, 4, 8, 12, 24
Measurement of serum oxytocin levels via a blood draw.
Week 0, 4, 8, 12, 24
Creatine Phosphokinase (CPK)
Time Frame: Week 0, 4, 8, 12, 24
Measurement of serum CPK via a blood draw.
Week 0, 4, 8, 12, 24
Serum Interleukin-6 (IL-6)
Time Frame: Week 0, 4, 8, 12, 24
Measurement of interleukin-6 (IL-6) via a blood draw.
Week 0, 4, 8, 12, 24
Serum Norepinephrine
Time Frame: Week 0, 4, 8, 12, 24
Measurement of norepinephrine via a blood draw.
Week 0, 4, 8, 12, 24
Indirect Calorimetry
Time Frame: Week 0,12, 24
This is a non-invasive procedure that measures how much energy the body uses.
Week 0,12, 24
Skin Biopsy (Optional)
Time Frame: Week 1, 12
2 optional biopsies will be take pre- and post-laser treatment to measure changes in collagen and skin thickness.
Week 1, 12
Skin Elasticity
Time Frame: Week 0, 4, 8, 12, 24
Ultrasound will be used to measure skin elasticity.
Week 0, 4, 8, 12, 24
Skin Thickness
Time Frame: Week 0, 4, 8, 12, 24
Ultrasound will be used to measure skin thickness.
Week 0, 4, 8, 12, 24
Hydration Status (%)
Time Frame: Week 0, 12
Estimation of total body water content as a percentage of body weight using the Bioelectrical impedance analysis (BIA).
Week 0, 12
VAS Pain Score
Time Frame: Week 1, 4, 8
The visual analog scale (VAS) pain score will be collected from the subject after each laser treatment. The VAS is a 10cm long scale with 0cm representing "no pain" and 10cm representing "worst possible pain".
Week 1, 4, 8
Total Body Bone Mineral Density (g/cm²)
Time Frame: Week 1, 12, 24
The total body BMD will be collected from the Dual energy x-ray absorptiometry scan (DEXA).
Week 1, 12, 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2027

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 18, 2025

First Submitted That Met QC Criteria

March 21, 2025

First Posted (Actual)

March 28, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025P000547

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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