Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles

NCT03831477 | Completed Results FDA Device

• 1 other identifier: VI1218
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Rhytides; Wrinkle

Keywords

fractional radiofrequency; fractional RF; wrinkles; facial wrinkles

Outcome Measures

Primary Outcomes (1)

• Change in Facial Wrinkles at 12 Weeks Post Final Treatment Compared to Baseline

  Change in facial wrinkles at 12 weeks post-treatment compared to baseline as assessed by blinded evaluators by photographic assessment utilizing the 9-point Fitzpatrick Wrinkle and Elastosis Scale (FWES). Scores of 1-3 indicate fine wrinkles with mild elastosis, scores 4-6 fine to moderate depth wrinkles with moderate elastosis and 7-9 fine to deep wrinkles with severe elastosis.

  12 Weeks Post Final Treatment

Secondary Outcomes (3)

• Subject Satisfaction

  12 Weeks Post-Final Treatment

• Subject Scale - Visual Analog Scale for Pain

  An average of all 3 treatments

• Subject Scale - 5 Point Scale for Treatment Tolerability

  An average of all 3 treatments

Study Arms (2)

80 pin applicator

EXPERIMENTAL

Device: Venus Viva

160 pin applicator

ACTIVE COMPARATOR

Device: Venus Viva

Interventions

Venus Viva DEVICE

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.

160 pin applicator; 80 pin applicator

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 systemic retinoids within six months or topical retinoids within three months prior to treatment; or as per physician's discretion.

Sponsors & Collaborators

• Venus Concept: lead

Study Sites (1)

Sadick Research Group

New York, New York, 10075, United States

Location

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: Venus Concept

mgronski@venusconcept.com

888-907-0115

Study Officials

• Matthew Gronski

  Venus Concept

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Evaluator blinded assessment of photographs
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, single centre, evaluator-blind study

Study Record Dates

• First Submitted: February 4, 2019
• First Posted: February 5, 2019
• Study Start: December 12, 2018
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: September 6, 2023
• Results First Posted: September 6, 2023

Record last verified: 2023-08

Locations

US (1)