Metabolism Enhancement by Laser Therapy

NCT06899958 | Not Yet Recruiting FDA Device

• 1 other identifier: 2025P000547
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolism Disorder

Outcome Measures

Primary Outcomes (6)

• 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).

  Week 1, 12, 24

• 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.

  Week 0, 4, 8, 12, 24

• Waist circumference (cm)

  These measurements will be taken at each of the following visits

  Week 0, 4, 8, 12, 24

• Hip circumference (cm)

  These measurements will be taken at each of the following visits

  Week 0, 4, 8, 12, 24

• Arm circumference (cm)

  These measurements will be taken at each of the following visits

  Week 0, 4, 8, 12, 24

• 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).

  Week 1, 12, 24

Secondary Outcomes (19)

• 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

Study Arms (1)

Fractional Laser treatment

EXPERIMENTAL

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

Device: Fractional Laser

Interventions

Fractional Laser DEVICE

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

Fractional Laser treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

MGH Clinical Unit for Research Trials & Outcomes in Skin

Boston, Massachusetts, 02114, United States

Location

Related Publications (17)

• 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.

  PMID: 38213618 BACKGROUND

• 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.

  PMID: 32030121 BACKGROUND

• 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.

  PMID: 34706925 BACKGROUND

• 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.

  PMID: 32734395 BACKGROUND

• 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.

  PMID: 26586436 BACKGROUND

• 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.

  PMID: 15216537 BACKGROUND

• 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.

  PMID: 16392146 BACKGROUND

• 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.

  PMID: 19213229 BACKGROUND

• 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.

  PMID: 23058108 BACKGROUND

• 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.

  PMID: 19787413 BACKGROUND

• 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.

  PMID: 27707498 BACKGROUND

• 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.

  PMID: 33909503 BACKGROUND

• 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.

  PMID: 19603107 BACKGROUND

• 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.

  PMID: 31606314 BACKGROUND

• 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.

  PMID: 32054846 BACKGROUND

• 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.

  PMID: 29408836 BACKGROUND

• 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.

  PMID: 10338224 BACKGROUND

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Central Study Contacts

Maria Alora, MD

CONTACT

617-726-4454; mansteinlab@mgh.harvard.edu

Alicia Van Cott, NP

CONTACT

617-726-4454; mansteinlab@mgh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, MGH Clinical Unit for Research Trials in Skin

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 28, 2025
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)