CompletedNot Applicable

Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles

United States25 participantsStarted 2019-03-08

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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Subject Satisfaction

Timeframe: 12 Weeks Post Last Treatment (Around Week 20)

Subject Satisfaction

Timeframe: 6 Weeks Post Last Treatment (Around Week 14)

Trial details

NCT IDNCT03776461

SponsorVenus Concept

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-18

Results submitted2023-06-21

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