The Efficacy of Nanofractional Radiofrequency Device in Arm Rejuvenation and Tightening : a Pilot Study

Study Overview
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Brief Summary
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The objective of this study is to evaluate arm rejuvenation and tightening with a nanofractional radiofrequency device, Venus viva, Venus concept, Toronto Canada. We recruit 20 subjects. All 20 subjects are treated with 3 sessions, 1 month interval with a nano fractional radiofrequency device on the inner upper arm. We evaluate skin tightening using %improvement of treated surface areas and skin elasticity using Dermalab the result at 3 months after the last treatment and clinical improvements evaluated by two board certified dermatologist (using compared photos between before treatment and 3 months after the last treatment).

Official Title
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The Efficacy of Nanofractional Radiofrequency Device in Arm Rejuvenation and Tightening : a Pilot Study

Conditions
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Skin Tightening and Rejuvenation

Intervention / Treatment
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* Device: a nanofractional radiofrequency device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Healthy female or male subjects, at least 30-60 years old of age 2. Subject who has BMI 18.50- 25 kg/m2 (as picture criteria above) 3. Subject has clinically evident moderate skin laxity with or without wrinkle on the upper arm 4. Subject has read and signed a written informed consent form. Exclusion Criteria: - 1. Patient with weight loss > 15% 2. Pregnancy or Lactation 3. History of pacemaker, defibrillator 4. History of laser resurfacing, prior radiofrequency, ultrasound or focused ultrasound on treatment areas within 1 year on the treatment area 5. History of Heat sensitivity, collagen vascular disorder disease including morphea, scleroderma, heat contact urticaria 6. History of medical illness that primary investigator thinks could interfere or influence the wound healing process 7. History of abnormal scars (keloid, hypertrophic scars) 8. History of skin cancer, radiation therapy or metal implants on treatment areas 9. Active local or systemic infection on treatment areas 10. Any other conditions that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject. 11. Subject is unable or unwilling to comply with the study requirements. 12. Subject is currently enrolled in a clinical study of any other unapproved investigational drug or device.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A nanofractional radiofrequency device<br> | Device: a nanofractional radiofrequency device<br>* A nanofractional radiofrequency device. noninvasive fractional radiofrequency device that provides ability to control and adjust the ratio of ablation and coagulation effect. Venus Viva, licensed by Health Canada, is cleared by the FDA for ablation and resurfacing dermatological procedures.<br>* Other names: Venus Viva, Venus concept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effects of arm rejuvenation and tightening | Determined by changing of the treated surface area (calculated from four-fixed tattoo points on the inner arm) surface area = length x width cm2 | 12 weeks after the last treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changing of skin laxity and elasticity | Evaluated by skin's viscoelastic properties using Dermalab, Courage Khazaka Electronic GmbH | 12 weeks after the last treatment | 
| Changing of skin wrinkles and laxity using photographs of subjects' baselines and 12 weeks after the last treatment by two independent board certified dermatologists | Determined by five point scale. (1) excellent improvement (>75%), (2) good improvement (50-75%), (3) fair improvement (25-50%), (4) some improvement (10-25%) and (5) little or no improvement (0-10%) | 12 weeks after the last treatment | 
| evaluate perceptions of treatment with a nano-fractional radiofrequency device | using five-point scale Five point scale evaluation: (1) excellent improvement (>75%), (2) good improvement (50-75%), (3) fair improvement (25-50%), (4) some improvement (10-25%) and (5) little or no improvement (0-10%) | 12 weeks after the last treatment |