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

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

NCT03831477•Venus Concept

View on ClinicalTrials.gov

Summary

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

The study will evaluate 15 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. An additional histological analysis will be conducted including up to 12 of the participating subjects.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Healthy, male or female subjects over 21 years of age who are seeking treatment and reduction of their facial wrinkles.
•2. Able to read, understand and voluntarily provide written Informed Consent.
•3. Able and willing to comply with the treatment/follow-up schedule and requirements.
•4. 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

•1. Implantable defibrillators, cardiac pacemakers, and other metal implants
•2. Subjects with any implantable metal device in the treatment area
•3. Pacemaker or internal defibrillator, or any other active electrical implant anywhere in the body (e.g. cochlear implant).
•4. Permanent implant in the treated area, such as metal plates and screws, or an injected chemical substance.
•5. Current or history of any kind of cancer, or pre-malignant moles.
•6. Severe concurrent conditions, such as cardiac disorders.
•7. Pregnancy or intending to become pregnant during the study and nursing.
•8. Impaired immune system due to immunosuppressive diseases, such as AIDS and HIV, or use of immunosuppressive medications.
•9. 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.
•10. Poorly controlled endocrine disorders, such as diabetes.
+10 more criteria

Locations (1)

Sadick Research Group

New York, New York, United States

Key Dates

Start Date

December 12, 2018

Primary Completion Date

August 9, 2019

Completion Date

August 9, 2019

Last Updated

September 6, 2023

Enrollment

ACTUAL participants

Conditions

RhytidesWrinkle

Interventions

Venus Viva

DEVICE

A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment

NCT07187297

WrinkleLax Skin+1 more

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 6, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Prospective Controlled Study to Evaluate the Safety and Effectiveness of Thermage® FLX Radiofrequency Treatment

Evaluation of Facial HA Dermal Fillers in Real-Life Conditions

2910 nm Erbium-Doped Fluoride Fiber Glass Laser for the Treatment of Advanced Perioral Lines and Wrinkles

The Effects of Almond on Facial Skin Collagen and Wrinkles

Feasibility Study to Collect and Assess Safety Data for a Radiofrequency Microneedling Device for Electrocoagulation and Hemostasis of Soft Tissues for Dermatologic Conditions

Prospective, Multicentre, Randomized, Blind, Parallel-controlled Clinical Trial Evaluating the Efficacy and Safety of Recombinant Collagen Gel for Correcting Moderate to Severe Nasolabial Wrinkles