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

RECRUITINGNA

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

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

NCT05987319•Cynosure, Inc.

View on ClinicalTrials.gov

Summary

The goal of the Potenza device used in this study is to collect clinical data for dermatologic conditions in which electrocoagulation and hemostasis is a viable mechanism for means of improvement.

Detailed Description

Up to 12 subjects will be enrolled at 1 study center. Subjects will be enrolled into 2 groups. Group A will receive treatments on the face, neck, and/or body. Group B will receive split-face treatments where each side of the face may be treated with different tips. Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments.

Eligibility

Age

22 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A healthy, non-smoking male or female between the age of 22-65 years old.
•Fitzpatrick skin type I to VI.
•Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
•Understands and accepts the obligation and is logistically able to be present for all visits.
•Is willing to comply with all requirements of the study and sign the informed consent document.

Exclusion Criteria

•Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the study.
•The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 1 month prior to entering this study.
•The subject has a pacemaker.
•The subject had previous use of gold thread skin rejuvenation.
•The subject has a cut, wound, or infected skin on the area to be treated (but skin eruptions may be treated).
•The subject has a metal implant that interferes with the transmission of energy to the electrical field.
•The subject has any embedded electronic devices that give or receive a signal.
•The subject has Implantable Cardiac Defibrillators (ICD) or Cardiac Resynchronization Therapy (CRT) devices: treatment may interfere with the functionality of the device and/or damage the electronic implant.
•The subject is allergic to adhesives such as glues on medical tape: they should be alerted that a rash may occur on the neutral electronic monitoring pad (NEM or neutral pad) site, and an over-the-counter preparation may be used to treat the area.
•The subject is allergic to gold.
+19 more criteria

Locations (1)

Cynosure, Inc.

Westford, Massachusetts, United States

Key Dates

Start Date

July 24, 2023

Primary Completion Date

August 1, 2024

Completion Date

August 1, 2024

Last Updated

May 7, 2024

Enrollment

ESTIMATED participants

Conditions

WrinkleFine LinesCrepey SkinAcne ScarsActive AcneEnlarged PoresStretch MarkLoose Skin

Interventions

RadioFrequency Microneedling Device

DEVICE

Contacts

Jamie Trimper

CONTACT

9782564200 jamie.trimper@cynosure.com

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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: May 7, 2024Data 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.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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