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

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ClinicalTrials.gov Identifier: NCT02791620
Recruitment Status : Unknown
Verified June 2016 by Chulalongkorn University.
Recruitment status was:  Recruiting
First Posted : June 7, 2016
Last Update Posted : June 7, 2016
Sponsor:
Collaborator:
Venus Concept
Information provided by (Responsible Party):
Chulalongkorn University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Skin Tightening and Rejuvenation Device: a nanofractional radiofrequency device Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of Nanofractional Radiofrequency Device in Arm Rejuvenation and Tightening : a Pilot Study
Study Start Date : June 2016
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : January 2017
Arms and Interventions
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Arm Intervention/treatment
Experimental: A nanofractional radiofrequency device Device: 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 Name: Venus Viva, Venus concept


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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%)

  3. 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%)


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791620


Locations
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Thailand
Department of Dermatology, Faculty of Medicine, Chulalongkorn University Recruiting
Bangkok, Thailand, 10330
Contact: Marisa Pongprutthipan, MD    022564253    Dr_marisa@yahoo.com   
Contact: Chanika Witoonchart, MD    022564253    C.kulapatrapa@gmail.com   
Sponsors and Collaborators
Chulalongkorn University
Venus Concept
More Information
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Publications:
Desai S. Nonsurgical Lifting and Tightening. Evidence-Based Procedural Dermatology: Springer; 2012. p. 287-300.

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Responsible Party: Chulalongkorn University
ClinicalTrials.gov Identifier: NCT02791620    
Other Study ID Numbers: 256/59
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: June 7, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No