Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles

Study Overview
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Brief Summary
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Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.

Detailed Description
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The study will evaluate 50 treatment sites in subjects requesting treatment of their facial wrinkles. The study will involve three treatments on both sides of the face with 3-5 week intervals between each treatment. Subjects will be followed at 6 and 12 weeks after their last treatment. Analysis will be performed on all subjects who receive at least one treatment

Official Title
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Clinical Evaluation of the Safety and Performance of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles

Conditions
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Rhytides, Wrinkle

Intervention / Treatment
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* Device: Venus Viva


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles. Able to read, understand and voluntarily provide written Informed Consent. Able and willing to comply with the treatment/follow-up schedule and requirements. Women of child-bearing age are required to be using a reliable method of birth control at least 3 months prior to study enrollment and for the duration of the study and have a negative Urine Pregnancy test at baseline. Exclusion Criteria: Implantable defibrillators, cardiac pacemakers, and other metal implants Subjects with any implantable metal device in the treatment area Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant). Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance. Current or history of any kind of cancer, or pre-malignant moles. Severe concurrent conditions, such as cardiac disorders. Pregnancy or intending to become pregnant during the study and nursing. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications. History of diseases stimulated by heat, such as recurrent herpes simplex in the treatment area; may be enrolled only after a prophylactic regime has been followed for 2 weeks or longer prior to enrollment , or according to Investigator's discretion . Poorly controlled endocrine disorders, such as diabetes. Any active condition in the treatment area, such as sores, psoriasis, eczema, and rash. History of skin disorders, such as keloids, abnormal wound healing, as well as very dry and fragile skin. History of bleeding coagulopathies, or use of anticoagulants (excluding daily aspirin). Facial dermabrasion, facial resurfacing, or deep chemical peeling within the last three months, if face is treated. Use of isotretinoin (Accutane®) or other retinoids within six months prior to treatment or as per physician's discretion. Use of non-steroidal anti-inflammatory drugs (NSAIDS, e.g. ibuprofen-containing agents) one week before and after each treatment session. Any surgical procedure in the treatment area within the last six months or before complete healing. Treating over tattoo or permanent makeup. Excessively tanned skin from sun, tanning beds or tanning creams within the last two weeks. As per the practitioner's discretion, refrain from treating any condition which might make it unsafe for the patient.

Ages Eligible for Study
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Minimum Age: 22 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
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single centre, evaluator-blind study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 80-pin applicator<br>3 treatments with the 80-pin tip applicator at 0, 4, and 8 weeks. | Device: Venus Viva<br>* The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.<br>|
| Active Comparator: 160 pin applicator<br>3 treatments with the 160-pin tip applicator at 0, 4, and 8 weeks. | Device: Venus Viva<br>* The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Satisfaction | Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment. | 12 Weeks Post Last Treatment (Around Week 20) | 
| Subject Satisfaction | Subjects' assessment of satisfaction with the treatment using a 5 point Subject Satisfaction Scale (0=Very Unsatisfied, 4=Very Satisfied) at 6 weeks and 12 weeks post-treatment. | 6 Weeks Post Last Treatment (Around Week 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Scale - Visual Analog Scale for Pain | Subject's assessment of discomfort and pain after treatments as measured by a 10 cm visual analog scale (VAS) with 0 being no pain and 10 being pain as bad as it can be. For each subject, the mean VAS score was taken from the 3 treatments. | Post Treatment at the Baseline, 4 Week and 8 Week treatment visits | 
| Subject Scale - 5 Point Scale for Treatment Tolerability With 0 Being Very Intolerable and 4 Very Tolerable. | Subject's assessment of treatment tolerability as measured by a 5-point scale. For each subject the mean of tolerability results from the 3 treatments was taken. | Post Treatment at the Baseline, 4 Week and 8 Week treatment visits | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractional radiofrequency, fractional RF, facial wrinkles, wrinkles