The Efficacy of Nanofractional Radiofrequency Device in Arm Rejuvenation and Tightening : a Pilot Study
June 1, 2016 updated by: Chulalongkorn University
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).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Bangkok, Thailand, 10330
- Recruiting
- Department of Dermatology, Faculty of Medicine, Chulalongkorn University
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Contact:
- Marisa Pongprutthipan, MD
- Phone Number: 022564253
- Email: Dr_marisa@yahoo.com
-
Contact:
- Chanika Witoonchart, MD
- Phone Number: 022564253
- Email: C.kulapatrapa@gmail.com
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: A nanofractional radiofrequency device
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effects of arm rejuvenation and tightening
Time Frame: 12 weeks after the last treatment
|
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
Time Frame: 12 weeks after the last treatment
|
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
Time Frame: 12 weeks after the last treatment
|
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
Time Frame: 12 weeks after the last treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- Desai S. Nonsurgical Lifting and Tightening. Evidence-Based Procedural Dermatology: Springer; 2012. p. 287-300.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Anticipated)
October 1, 2016
Study Completion (Anticipated)
January 1, 2017
Study Registration Dates
First Submitted
June 1, 2016
First Submitted That Met QC Criteria
June 1, 2016
First Posted (Estimate)
June 7, 2016
Study Record Updates
Last Update Posted (Estimate)
June 7, 2016
Last Update Submitted That Met QC Criteria
June 1, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 256/59
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
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