To Verify Tissue Heating and Temperature Stability and Safety Throughout RF Treatment Duration Applied on the Face
Conditions
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.
Interventions
DEVICENuEra Tight RF system
monopolar radiofrequency device
Sponsors
Lumenis Be Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| tissue heating | 12 minutes | 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 |
| temperature stability | 12 minutes | 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 |
Countries
United States
Outcome results
None listed