Laser Therapy for Metabolic Disorders

(MELT Trial)

Overseen By Alicia Van Cott, NP

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: GLP-1 agonists, Antidepressants, Thyroid meds, HRT

Disqualifiers: Pregnancy, Alcohol abuse, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 36 weeks

15 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you do not take medications that may affect body weight, such as GLP-1 receptor agonists, amitriptyline, bupropion, thyroid medications, or hormone replacement therapy. If you are on these medications, you may need to stop them to participate.

How is Fractional Laser treatment unique for metabolic disorders?

Fractional Laser treatment is unique because it uses laser technology to create tiny thermal wounds in the skin, which is a novel approach compared to traditional treatments for metabolic disorders. This method is typically used for skin rejuvenation and other skin conditions, suggesting a new application for metabolic issues. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Eligibility Criteria

Adults aged 18-60 with a BMI of 25.0 to 30 kg/m2 in good health can join this study on laser therapy for metabolism. They must not be pregnant, breastfeeding, or have had significant weight changes recently and should agree to use effective birth control.

Inclusion Criteria

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

Exclusion Criteria

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

History of drug or alcohol abuse in the past 3 years or habitual alcohol intake greater than 2 standard drinks per day

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo three fractional laser treatments on the abdomen and thighs over 36 weeks, with sessions every four weeks

36 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Fractional Laser

Trial Overview The trial is testing the effects of large area fractional laser treatment (LAFLT) on metabolic profiles in adults. It's an open-label pilot study at a single center where participants will receive LAFLT to see how it affects their metabolism.

Participant Groups

Group I: Fractional Laser treatment Experimental Treatment 1 Intervention

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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluating facial pores and skin texture after low-energy nonablative fractional 1440-nm laser treatments. [2012]

2. United States pubmed.ncbi.nlm.nih.gov

Fractional photothermolysis for skin rejuvenation. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Formation of fibrosis after nonablative and ablative fractional laser therapy. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Clinical effects of non-ablative and ablative fractional lasers on various hair disorders: a case series of 17 patients. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Fractionated laser skin resurfacing treatment complications: a review. [2022]