Subject who has clinically evident of excess fat tissue on flanks (love handles) area,
Conditions
Interventions
The 1064 nm Nd:YAG laser used in the study are a Fotona XP Dynamis laser system (PIANO mode) with L-
Runner Pro scanning hand piece (the scanning surface was 76 mm x 84 mm).
Each flank area are divided into two adjacent skin areas,
which are sequentially heated.
Each area will be irradiated until the skin temperature reached the surface of 40-
41 °c then the irradiation will be moved to the next area within the cycle for a total of five cycles.
Non-
contact skin cooling will be used to cool down the irradiated surface during procedure. After irradiation,
the skin surface will be left to cool down by natural convection.
Experimental Device
Laser treatment
Sponsors
None listed
Eligibility
Sex/Gender
All
Age
25 Years to 60 Years
Inclusion criteria
Inclusion criteria: Healthy subject who has clinically evident of excess fat tissue on flanks (love handles) area, defined by easily seen the fatty bulges extend on the sides of subjects’ waistline or easily pinch the fatty bulges on flanks without an effort.
Exclusion criteria
Exclusion criteria: 1.Patients with weight gain or weight loss > 10% from baseline within 3 months. 2.Pregnancy or Lactation 3.Currently on treatments of obesity neither medications for weight loss such as metformin, liraglutide, and orlistat, nor procedures such as injectable of deoxycholic acid and liposuction. 4.History of abdominal cosmetic or surgical treatments 5.History of heat sensitivity, collagen vascular disorders including morphea, scleroderma, heat contact urticarial 6.History of medical illness that could interfere or influence the wound healing process 7.History of abnormal scars (keloid and hypertrophic scars) or hernia 8.History of skin cancer, radiation therapy, or metal implants on treatment areas 9.Active local or systemic infections or inflammation on treatment areas 10.History of body dysmorphic disorders or other psychological conditions 11.Any other conditions that would, in the professional opinion of the investigators, potentially affect the subject’s response or the integrity of the data or would pose an unacceptable risk to the subject. 12.Subject is unable or unwilling to comply with the study requirements. 13.Subject is currently enrolled in a clinical study of any other unapproved investigational drugs or devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percentage change of subcutaneous fat thickness 8 week follow up period ultrasonography,percentage change of subcutaneous fat thickness 8 week follow up period ultrasonography,percentage change of subcutaneous fat thickness 8 week follow up period ultrasonography | — |
Secondary
| Measure | Time frame |
|---|---|
| changing of body shape baseline and 8 weeks follow up period photographs,changing in waist circumference baseline to 8 week follow up period tape measure,possible side effects every visit for 8 week follow up period pain VAS | — |
Countries
Thailand
Contacts
Public ContactRujira Rujiwetpongstorn
Chulalongkorn University
Outcome results
None listed