Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

NCT ID: NCT05957029

Last Updated: 2023-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-22
• Study Completion Date: 2023-07-19

Brief Summary

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.

Conditions

To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NuEra Tight RF system

Intervention Type: DEVICE

monopolar radiofrequency device

Interventions

NuEra Tight RF system

monopolar radiofrequency device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lumenis Be Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Lewis Dermatology & Associates

Shauna Diggs, MD

Role: PRINCIPAL_INVESTIGATOR

Cosmedic Dermatology

Locations

Cosmedic Dermatology

Detroit, Michigan, United States

Lewis Dermatology & Associates

New York, New York, United States

Countries

United States

Other Identifiers

LUM-VBU-NUERA-23-02

Identifier Type: -

Identifier Source: org_study_id