Clinical trial NCT02791620: The Efficacy of Nanofractional Radiofrequency Device in Arm Rejuvenation and Tightening : a Pilot Study
Official title: The Efficacy of Nanofractional Radiofrequency Device in Arm Rejuvenation and Tightening : a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Skin Tightening and Rejuvenation
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
Collaborators: name: Venus Concept
First posted: 2016-06-07
Enrollment: 20
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Effects of arm rejuvenation and tightening
timeFrame: 12 weeks after the last treatment
Secondary outcomes:
measure: Changing of skin laxity and elasticity
timeFrame: 12 weeks after the last treatment
measure: Changing of skin wrinkles and laxity using photographs of subjects' baselines and 12 weeks after the last treatment by two independent board certified dermatologists
timeFrame: 12 weeks after the last treatment
measure: evaluate perceptions of treatment with a nano-fractional radiofrequency device
timeFrame: 12 weeks after the last treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Dermatology, Faculty of Medicine, Chulalongkorn University
Study officials:
References:
citation: Elsaie ML, Choudhary S, Leiva A, Nouri K. Nonablative radiofrequency for skin rejuvenation. Dermatol Surg. 2010 May;36(5):577-89. doi: 10.1111/j.1524-4725.2010.01510.x. Epub 2010 Apr 2. No abstract available.
citation: Hruza G, Taub AF, Collier SL, Mulholland SR. Skin rejuvenation and wrinkle reduction using a fractional radiofrequency system. J Drugs Dermatol. 2009 Mar;8(3):259-65.
citation: Hantash BM, Ubeid AA, Chang H, Kafi R, Renton B. Bipolar fractional radiofrequency treatment induces neoelastogenesis and neocollagenesis. Lasers Surg Med. 2009 Jan;41(1):1-9. doi: 10.1002/lsm.20731.
citation: Sukal SA, Geronemus RG. Thermage: the nonablative radiofrequency for rejuvenation. Clin Dermatol. 2008 Nov-Dec;26(6):602-7. doi: 10.1016/j.clindermatol.2007.09.007.
citation: Desai S. Nonsurgical Lifting and Tightening. Evidence-Based Procedural Dermatology: Springer; 2012. p. 287-300.