The efficacy of a super-long pulse 1064 Nd:YAG for localized noninvasive subcutaneous fat reduction of flanks; a prospective clinical trial
- Conditions
- Subject who has clinically evident of excess fat tissue on flanks (love handles) area񫫨 Nd:YAG laserdefined by easily seen the fatty bulges extend on the sides of subjects’ waistline or easily pinch the fatty buhyperthermic laser lipolysis,PIANO mode,super long pulse,
- Registration Number
- TCTR20201101001
- Lead Sponsor
- /A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending (Not yet recruiting)
- Sex
- All
- Target Recruitment
- 17
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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