An Assessment of Safety and Efficacy of the abdominal subcutaneous fat reduction effects of ALPHA: Prospective, Multicenter, Single arm and Academic clinical trial
- Conditions
- Endocrine, nutritional and metabolic diseases
- Registration Number
- KCT0007415
- Lead Sponsor
- Chung-Ang Univerisity Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 25
1) Men and women aged 19 to 65 years (international age)
2) Subjects whose abdominal fat is clearly visible and the abdominal fat thickness under the umbilicus measured by caliper ? 1.5 cm [19]
3) Subjects with BMI ? 35 kg/m2 [31][32]
4) Subjects with weight change ? 5% from the past month [20][21]
5) Subjects who agreed to maintain their weight (ie, weight change ? 5%) by not changing their daily personal habits such as eating habits, exercise habits and lifestyle during the entire clinical trial [20][21]
6) Subjects who can understand and follow instructions and be able to participate throughout the clinical trial.
7) Subjects who voluntarily decided to participate in this clinical trial and gave written consent to the subject consent form.
1) Subjects with sagging skin with no elasticity in the abdomen.
2) In the past 6 months, subjects who received the abdominal liposuction, abdominoplasty, mesotherapy, HIFU, cryolipolysis, dermal filler, radiofrequency or laser treatment, or chemical dermabrasion, Botulinum toxin injection, etc., which are considered to have an impact on this clinical trial; subjects who received non-surgical treatment.
3) Subjects with scars from open treatment (laparoscopic treatment) on the abdomen
4) Subjects with the abdominal dermatological abnormalities (injury marks, keloid skin, abnormal wound healing, open wounds), hernias or acute and chronic dermatological lesions (dermatitis, vitiligo, eczema, rash, psoriasis), systemic lupus erythematosus, scleroderma, etc.), skin paresthesia, peripheral circulatory insufficiency
5) Subjects sensitive to cold and heat, such as Raynaud's phenomenon, cold urticaria, cryoglobulinemia, and paroxysmal cold hemoglobinuria
6) Subjects taking drugs that affect weight loss or undergoing therapy (including exercise therapy)
7) Subjects with implanted devices containing metals or cardiac pacemakers, defibrillators, drug delivery systems
8) Subjects who have participated in other clinical trials within 6 months from the screening date or are currently participating in other clinical trials
9) Subjects who have a blood clotting disorder-related disease in the body, such as hemostasis or thrombosis, or receive anticoagulant therapy, anticoagulant drugs, or anticoagulant diet to treat these diseases
10) Subjects who have been diagnosed with or are currently receiving treatment for Lipid metabolism disease, autoimmune disease not controlled by drugs, severe cardiovascular disease, severe diabetes, severe liver disease or severe kidney disease, mental disease, neurological disorder that may have a significant effect on this clinical trial
11) Pregnant or lactating women
12) Subjects who do not agree to contraception* by a medically accepted method until 12 weeks (17 weeks of clinical trial period) after the last treatment of the clinical trial medical device in this clinical trial among female subjects of childbearing potential * Medically accepted contraceptive methods: condoms, oral contraceptives lasting for at least 4 months, use of injectable or implantable contraceptives, installation of intrauterine contraceptives, etc.
13) Subjects who are judged inappropriate to participate in clinical trials by the judgment of investigators
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The reduction rate of the abdominal subcutaneous fat at week 12 (8 weeks after the second treatment) compared to at week 0 (baseline) measured by ultrasound
- Secondary Outcome Measures
Name Time Method Changes in weight and BMI;Changes in the abdominal fat thickness measured with caliper;the abdominal subcutaneous fat reduction measured by ultrasound;The reduction rate of the abdominal subcutaneous fat measured by ultrasound (excluding the time of primary efficacy endpoint);Abdominal circumference, hip circumference and the rate change of the abdominal circumference to hip circumference;Independent evaluators’ assessment_Abdominal photo discrimination rate;Subject satisfaction Assessment