The efficacy of a non-invasive 1060 nm Diode laser for Submental lipolysis: A pilot study

Completed

• Conditions: unwanted localized submental fat; 1,060 nm Diode laser; fat reduction; submental fat

• Registration Number: TCTR20220218004
• Lead Sponsor: Faculty of Medicine Siriraj Hospital, Mahidol University

Brief Summary

1060 nm Diode laser demonstrated significant efficacy and safety for submental fat reduction. Reduction of submental fat may not only improve ones facial appearance, but also may enhance ones emotional and social health. It provides an alternative treatment for patients seeking an in-office, nonsurgical procedure for fat reduction.

Detailed Description

Not available

Study Timeline

• Study Completion: 2019-09-17
• Study Start: 2022-02-18
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

All female subjects complained of unwanted localized submental fat. Presenting with body mass index (BMI) of 18.5 to 30 kg/m2.

Exclusion Criteria

pregnant or lactating women, previous history of liposuction and surgical procedures, previ-ous laser procedures, no evidence of compromised healing, no prior treatment of gold ther-apy, had history of immunodeficiency disorders including HIV infection or AIDS, use of im-munosuppressive medications, had previous history of neuropathic disorder, presence of impaired skin sensation or diabetic neuropathy, previous history of herpes virus infection, underlying psychological conditions, history of skin malignancies, history of hypertrophic scar or keloid formation, history of any skin infections and skin hypersensitivity or photosen-sitivity reaction.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Submental Fat layer thickness baseline,1-month, 3-month, and 6-month follow-up visits after the treatment ultrasound

Secondary Outcome Measures

Name	Time	Method
safety baseline,1-month, 3-month, and 6-month follow-up visits after the treatment Physical examination and history taking,subject satisfaction 1-month, 3-month, and 6-month follow-up visits after the treatment All subjects answered the percentage improvement scale survey at every follow-up visit.