CompletedNot Applicable

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

United States15 participantsStarted 2018-12-12

Plain-language summary

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

Who can participate

Age range22 Years

SexALL

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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.

What they're measuring

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

Timeframe: 12 Weeks Post Final Treatment

Trial details

NCT IDNCT03831477

SponsorVenus Concept

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2019-08-09

Results submitted2023-07-27

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