Evaluation of Thermal Outcome and Safety of Nuera Tight RF System

Lumenis

Status: Completed

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

Treatments: Device: NuEra Tight RF system

Study type: Interventional

Funder types: Industry

Identifiers

NCT05957029

LUM-VBU-NUERA-23-02

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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46 participants in 1 patient group

Nuera Tight RF System

Experimental group

Description:

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.

Treatment:

Device: NuEra Tight RF system