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Not yet recruitingNCT06899958MELTUpdated Feb 11, 2026

Metabolism Enhancement by Laser Therapy

An interventional study of Fractional Laser in Metabolism Disorder, sponsored by Massachusetts General Hospital. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-11.

Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Metabolism Disorder

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03

In context

Metabolic Diseases

997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.

This study's planned enrollment of 15 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.

Browse Metabolic Diseases studies →

Lead sponsor

Massachusetts General Hospital is the lead sponsor of 2,536 studies on the registry; 446 are open to participants now.

Of its 214 completed or terminated interventional studies of FDA-regulated products, 161 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (estimated)

Study arms

  • Experimental
    Fractional Laser treatment

    Large Area Fractional Laser treatments to the abdomen and thighs using the MIRIA laser.

    Device: Fractional Laser

Interventions

  • DeviceFractional Laser

    Three fractional laser treatments to the abdomen and thighs at 4 week intervals.

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What researchers measure

Primary outcomes

  1. Percent Body Fat (%)

    The percent body fat will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).

    Time frame: Week 1, 12, 24

  2. Body Mass Index (BMI) (kg/m²)

    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.

    Time frame: Week 0, 4, 8, 12, 24

  3. Waist circumference (cm)

    These measurements will be taken at each of the following visits

    Time frame: Week 0, 4, 8, 12, 24

  4. Hip circumference (cm)

    These measurements will be taken at each of the following visits

    Time frame: Week 0, 4, 8, 12, 24

  5. Arm circumference (cm)

    These measurements will be taken at each of the following visits

    Time frame: Week 0, 4, 8, 12, 24

  6. Total Lean Body Mass (kg)

    The total lean body mass will be collected from the Dual energy x-ray absorptiometry scan (DEXA) and via the Bioelectrical Impedance Analysis (BIA).

    Time frame: Week 1, 12, 24

Secondary outcomes

  1. Complete Blood Count (CBC)

    Measurement of red blood cell count, white blood cell count, hemoglobin, hematocrit, and platelet count via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  2. Comprehensive Metabolic Panel (CMP)

    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.

    Time frame: Week 0, 4, 8, 12, 24

  3. Lipid Panel

    Measurement of total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  4. HbA1c

    Measurement of hemoglobin A1c via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  5. C-Reactive Protein (CRP)

    Measurement of CRP levels via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  6. Erythrocyte Sedimentation Rate (ESR)

    Assessment of the rate at which red blood cells sediment via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  7. Histamine

    Measurement of plasma histamine levels via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  8. Cortisol

    Measurement of serum cortisol levels via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  9. Oxytocin

    Measurement of serum oxytocin levels via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  10. Creatine Phosphokinase (CPK)

    Measurement of serum CPK via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  11. Serum Interleukin-6 (IL-6)

    Measurement of interleukin-6 (IL-6) via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  12. Serum Norepinephrine

    Measurement of norepinephrine via a blood draw.

    Time frame: Week 0, 4, 8, 12, 24

  13. Indirect Calorimetry

    This is a non-invasive procedure that measures how much energy the body uses.

    Time frame: Week 0,12, 24

  14. Skin Biopsy (Optional)

    2 optional biopsies will be take pre- and post-laser treatment to measure changes in collagen and skin thickness.

    Time frame: Week 1, 12

  15. Skin Elasticity

    Ultrasound will be used to measure skin elasticity.

    Time frame: Week 0, 4, 8, 12, 24

  16. Skin Thickness

    Ultrasound will be used to measure skin thickness.

    Time frame: Week 0, 4, 8, 12, 24

  17. Hydration Status (%)

    Estimation of total body water content as a percentage of body weight using the Bioelectrical impedance analysis (BIA).

    Time frame: Week 0, 12

  18. VAS Pain Score

    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".

    Time frame: Week 1, 4, 8

  19. Total Body Bone Mineral Density (g/cm²)

    The total body BMD will be collected from the Dual energy x-ray absorptiometry scan (DEXA).

    Time frame: Week 1, 12, 24

07

Study locations

1 site
  • MGH Clinical Unit for Research Trials & Outcomes in Skin
    Boston, Massachusetts 02114, United States
08

References and documents

Publications

  • Salma N, Wang-Evers M, Karasik D, Yerevanian A, Downs H, Luo T, Doyle AE, Tannous Z, Cacicedo JM, Manstein D. Large area fractional laser treatment of mouse skin increases energy expenditure. iScience. 2023 Dec 7;27(1):108677. doi: 10.1016/j.isci.2023.108677. eCollection 2024 Jan 19. PubMed 38213618 ↗
  • May M, Schindler C, Engeli S. Modern pharmacological treatment of obese patients. Ther Adv Endocrinol Metab. 2020 Jan 22;11:2042018819897527. doi: 10.1177/2042018819897527. eCollection 2020. PubMed 32030121 ↗
  • Singh G, Krauthamer M, Bjalme-Evans M. Wegovy (semaglutide): a new weight loss drug for chronic weight management. J Investig Med. 2022 Jan;70(1):5-13. doi: 10.1136/jim-2021-001952. Epub 2021 Oct 27. PubMed 34706925 ↗
  • Bettini S, Belligoli A, Fabris R, Busetto L. Diet approach before and after bariatric surgery. Rev Endocr Metab Disord. 2020 Sep;21(3):297-306. doi: 10.1007/s11154-020-09571-8. PubMed 32734395 ↗
  • Patsouris D, Qi P, Abdullahi A, Stanojcic M, Chen P, Parousis A, Amini-Nik S, Jeschke MG. Burn Induces Browning of the Subcutaneous White Adipose Tissue in Mice and Humans. Cell Rep. 2015 Nov 24;13(8):1538-44. doi: 10.1016/j.celrep.2015.10.028. Epub 2015 Nov 12. PubMed 26586436 ↗
  • Manstein D, Herron GS, Sink RK, Tanner H, Anderson RR. Fractional photothermolysis: a new concept for cutaneous remodeling using microscopic patterns of thermal injury. Lasers Surg Med. 2004;34(5):426-38. doi: 10.1002/lsm.20048. PubMed 15216537 ↗
  • Laubach HJ, Tannous Z, Anderson RR, Manstein D. Skin responses to fractional photothermolysis. Lasers Surg Med. 2006 Feb;38(2):142-9. doi: 10.1002/lsm.20254. PubMed 16392146 ↗
  • Gotkin RH, Sarnoff DS, Cannarozzo G, Sadick NS, Alexiades-Armenakas M. Ablative skin resurfacing with a novel microablative CO2 laser. J Drugs Dermatol. 2009 Feb;8(2):138-44. PubMed 19213229 ↗
  • Prignano F, Ricceri F, Bonan P, Cannarozzo G, Campolmi P. Induction of apoptosis by fractional CO2 laser treatment. J Cosmet Laser Ther. 2012 Dec;14(6):267-71. doi: 10.3109/14764172.2012.738820. PubMed 23058108 ↗
  • Bogdan Allemann I, Kaufman J. Fractional photothermolysis--an update. Lasers Med Sci. 2010 Jan;25(1):137-44. doi: 10.1007/s10103-009-0734-8. PubMed 19787413 ↗
  • Porter C, Tompkins RG, Finnerty CC, Sidossis LS, Suman OE, Herndon DN. The metabolic stress response to burn trauma: current understanding and therapies. Lancet. 2016 Oct 1;388(10052):1417-1426. doi: 10.1016/S0140-6736(16)31469-6. PubMed 27707498 ↗
  • Knuth CM, Auger C, Jeschke MG. Burn-induced hypermetabolism and skeletal muscle dysfunction. Am J Physiol Cell Physiol. 2021 Jul 1;321(1):C58-C71. doi: 10.1152/ajpcell.00106.2021. Epub 2021 Apr 28. PubMed 33909503 ↗
  • Jeschke MG. The hepatic response to thermal injury: is the liver important for postburn outcomes? Mol Med. 2009 Sep-Oct;15(9-10):337-51. doi: 10.2119/molmed.2009.00005. Epub 2009 Apr 10. PubMed 19603107 ↗
  • Hew JJ, Parungao RJ, Shi H, Tsai KH, Kim S, Ma D, Malcolm J, Li Z, Maitz PK, Wang Y. Mouse models in burns research: Characterisation of the hypermetabolic response to burn injury. Burns. 2020 May;46(3):663-674. doi: 10.1016/j.burns.2019.09.014. Epub 2019 Oct 10. PubMed 31606314 ↗
  • Jeschke MG, van Baar ME, Choudhry MA, Chung KK, Gibran NS, Logsetty S. Burn injury. Nat Rev Dis Primers. 2020 Feb 13;6(1):11. doi: 10.1038/s41572-020-0145-5. PubMed 32054846 ↗
  • Stanojcic M, Abdullahi A, Rehou S, Parousis A, Jeschke MG. Pathophysiological Response to Burn Injury in Adults. Ann Surg. 2018 Mar;267(3):576-584. doi: 10.1097/SLA.0000000000002097. PubMed 29408836 ↗
  • Yu YM, Tompkins RG, Ryan CM, Young VR. The metabolic basis of the increase of the increase in energy expenditure in severely burned patients. JPEN J Parenter Enteral Nutr. 1999 May-Jun;23(3):160-8. doi: 10.1177/0148607199023003160. PubMed 10338224 ↗

Individual participant data

Plan to share: No — There is no plan to make individual participant data (IPD) available to other researchers.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06899958
Lead sponsor
Massachusetts General Hospital
Responsible party
Maria Alora (Director, MGH Clinical Unit for Research Trials in Skin, Massachusetts General Hospital) — Principal investigator
First posted
Mar 28, 2025
Start date
Jan 1, 2027 (estimated)
Primary completion
Dec 2028 (estimated)
Completion
Dec 31, 2029 (estimated)
Last update
Feb 11, 2026

Study contacts

Maria Alora, MD
Contact
mansteinlab@mgh.harvard.edu
617-726-4454
Alicia Van Cott, NP
Contact
mansteinlab@mgh.harvard.edu
617-726-4454

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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