Facial Skin Laxity Clinical Trial
Official title:
Thermage FLX System to Treat the Face, Neck, and Eyelids for Correction of Mild to Moderate Skin Laxity.
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01368965 -
Lifting and Tightening of the Face in Subjects With Skin of Darker Color
|
N/A | |
| Completed |
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Clinical Study on the Application of a Non-Invasive Micro-Focused Ultrasound With Visualization System for Skin Laxity (ULT-215)
|
N/A |