Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
15 participants
INTERVENTIONAL
2025-04-01
2026-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fractional Laser treatment
Large Area Fractional Laser treatments to the abdomen and thighs using the MIRIA laser.
Fractional Laser
Three fractional laser treatments to the abdomen and thighs at 4 week intervals.
Interventions
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Fractional Laser
Three fractional laser treatments to the abdomen and thighs at 4 week intervals.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
60 Years
ALL
Yes
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Maria Alora
Director, MGH Clinical Unit for Research Trials in Skin
Locations
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MGH Clinical Unit for Research Trials & Outcomes in Skin
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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2025P000547
Identifier Type: -
Identifier Source: org_study_id
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