Metabolism Enhancement by Laser Therapy

Обзор

This is a single-center, open-label pilot study to determine the effect of large area fractional laser treatment (LAFLT) on adults' metabolic profile.

Подробное описание

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.

Вмешательства

• Устройство Fractional Laser
  Three fractional laser treatments to the abdomen and thighs at 4 week intervals.

Первичные конечные точки

• Percent Body Fat (%) [Срок оценки: Week 1, 12, 24]
• Body Mass Index (BMI) (kg/m²) [Срок оценки: Week 0, 4, 8, 12, 24]
• Waist circumference (cm) [Срок оценки: Week 0, 4, 8, 12, 24]
• Hip circumference (cm) [Срок оценки: Week 0, 4, 8, 12, 24]
• Arm circumference (cm) [Срок оценки: Week 0, 4, 8, 12, 24]
• Total Lean Body Mass (kg) [Срок оценки: Week 1, 12, 24]

Вторичные конечные точки (12)

• Complete Blood Count (CBC) [Срок оценки: Week 0, 4, 8, 12, 24]
• Comprehensive Metabolic Panel (CMP) [Срок оценки: Week 0, 4, 8, 12, 24]
• Lipid Panel [Срок оценки: Week 0, 4, 8, 12, 24]
• HbA1c [Срок оценки: Week 0, 4, 8, 12, 24]
• C-Reactive Protein (CRP) [Срок оценки: Week 0, 4, 8, 12, 24]
• Erythrocyte Sedimentation Rate (ESR) [Срок оценки: Week 0, 4, 8, 12, 24]
• Histamine [Срок оценки: Week 0, 4, 8, 12, 24]
• Cortisol [Срок оценки: Week 0, 4, 8, 12, 24]
• Oxytocin [Срок оценки: Week 0, 4, 8, 12, 24]
• Creatine Phosphokinase (CPK) [Срок оценки: Week 0, 4, 8, 12, 24]
• Serum Interleukin-6 (IL-6) [Срок оценки: Week 0, 4, 8, 12, 24]
• Serum Norepinephrine [Срок оценки: Week 0, 4, 8, 12, 24]

Критерии участия

Критерии включения

• 18- 60 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.

Критерии исключения

• 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;
• Use of any prescription topical medication, such as corticosteroids or hydroquinone on the abdomen or thighs in the past 6 weeks;
• History of keloid formation or hypertrophic scarring;
• History of bariatric surgery or other major weight-loss procedures;
• History of abdominal liposuction, abdominoplasty or CoolSculpting;
• Known allergy to lidocaine or other local anesthetics;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• MGH Clinical Unit for Research Trials & Outcomes in Skin — Boston

Публикации

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Идентификаторы

NCT: NCT06899958 · 2025P000547

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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