NCT03894371

Thermage FLX System to Treat the Face, Neck, and Eyelids

Thermage FLX System to Treat the Face, Neck, and Eyelids for Correction of Mild to Moderate Skin Laxity.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Nashville Centre for Laser and Facial Surgery · Academic / Other
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Accepted

Summary

25 subjects Fitzpatrick skin type I-VI with mild to moderate laxity of the skin of the face, neck, and eyelids will be enrolled. All subjects will undergo treatment with the Thermage FLX system using a 900 pulse, 4cm2 Total Tip to treat the face and neck and a 450 pulse, 0.25cm2 tip to treat the upper and lower eyelids.

Detailed description

Face/neck: Using a 900 pulse 4.0cm2 Total Tip, 450 pulses will be placed on one half of face/neck on average-large size face, 450 on the other half. Pulses to be placed using several initial passes throughout the treatment zones followed by any remaining pulses to problem areas, as determined by the Investigator. On a petite-small size patient, less pulses may be used on each half of treatment area, at the discretion of the Treating Investigator. Treatment will be performed in the standard manner titrating energy to a subjective discomfort of 2-3 on a 4-point scale, using generous amounts of coupling fluid, and placing return pad on the lower back. Eyes: Plastic corneoscleral protective lenses will be ised when the eyelids are treated. Using a 450 pulse 0.25cm2 eye tip, 225 pulses will be placed on one eye, 225 on the other eye. Pulses to be placed using several initial passes throughout the treatment zones, followed by any remaining pulses to problem areas, as determined by the Investigator. Treatment will be performed in the standard manner titrating energy to a subjective discomfort of 2-3 on a 4-point scale, using generous amounts of coupling fluid, and placing the return pad on the lower back. Photographs will be obtained by a professional photographer. Images will be captured at Baseline, and 1, 3, and 6 months post treatment. Treatment outcomes will be assessed at each visit by Subject Global Assessment Improvement Scale (SGAIS), Physician Global Assessment Improvement Scale (PGAIS) abd by blinded assessment of photographs by an independent reviewer. Subjects will be assessed by the Treating Investigator (live) and the non-treating investigator (photographs) using a quartile scale as in the previously published Thermage eyelid trial. Subject satisfaction will also be measured with questionnaires.

Conditions

• Facial Skin Laxity

Interventions

Type	Name	Description
DEVICE	Thermage FLX	Thermage FLX system for the correction of mild to moderate laxity of the skin of the face, neck, and eyelids.

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-11-01
• Completion: 2019-12-01
• First posted: 2019-03-28
• Last updated: 2019-03-28