Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

The purpose of the study is to verify tissue heating, temperature stability and safety of the Nuera Tight RF device during and after treatment session applied on the face.

Study Overview

• Status: Completed
• Conditions: To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face
• Intervention / Treatment: Device: NuEra Tight RF system

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48230
      • Cosmedic Dermatology
  • New York
    • New York, New York, United States, 10021
      • Lewis Dermatology & Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Healthy subjects of either gender, 18 years of age or older
• Subject is able to read, understand and sign an informed consent form
• Subject is willing to comply with all study procedures

Exclusion Criteria:

• Subjects taking medicines that increase skin sensitivity to heat
• Subjects taking medicines that change skin metabolism
• Cancer or any pigmentary or vascular lesions in the planned treatment area
• Subjects with Herpes simplex in the area to be treated
• Pregnant women
• Subjects wearing pacemakers and/or any other type of implanted electronics
• Subjects with any inflammatory skin conditions
• Subjects with active cold sores, open lacerations, abrasions
• Chronic or acute skin infections
• Subjects with active local or systemic infections
• Subjects with any disease in which an increase of skin temperature is contraindicated
• Subjects wearing piercing in the area to be treated
• Subjects have nerve insensitivity to heat in the area to be treated
• Subjects have metal implants in the area to be treated, excluding dental implants
• Subjects allergic to glycerin, paraffin, parfum, parabens, nuts, vegetable oils, calendula, or chamomile
• Any condition where the study investigator determined that the subject is not adequate for this study
• Subjects participating in other studies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nuera Tight RF System; Subjects will receive an RF treatment session on the periorbital area and cheeks with a frequency of 1 and 4 MHz. Each subject will be treated on one side of the face using a 10 mm capacitive electrode, and on the other side using a 20 mm capacitive electrode. The target temperature will be set at 42 C.	Device: NuEra Tight RF system; monopolar radiofrequency device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
tissue heating	To verify tissue heating throughout the treatment duration applied on the face. The temperature will be set at 42 C, the operator will move the electrode in a continuous motion until the skin temperature reached the target temperature, then the treatment will continue for another 12 minutes. the skin temperature will be measured using an infrared thermometer to verify tissue heating	12 minutes
temperature stability	To verify temperature stability throughout the treatment duration applied on the face. the skin temperature will be measured using an infrared thermometer every 3 minutes to verify temperature stability	12 minutes

Collaborators and Investigators

• Sponsor: Lumenis Be Ltd.
• Investigators: Principal Investigator: Amy Lewis, MD, Lewis Dermatology & Associates; Principal Investigator: Shauna Diggs, MD, Cosmedic Dermatology

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2023
• Primary Completion (Actual): July 19, 2023
• Study Completion (Actual): July 19, 2023

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: July 19, 2023
• First Posted (Estimated): July 24, 2023

Study Record Updates

• Last Update Posted (Estimated): July 24, 2023
• Last Update Submitted That Met QC Criteria: July 19, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: LUM-VBU-NUERA-23-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No