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.

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.

Study Overview

• Status: Unknown
• Conditions: Facial Skin Laxity
• Intervention / Treatment: Device: Thermage FLX

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda D Spear, CCRC; Phone Number: 615329-1110; Email: amanda@drbiesman.com
• Study Contact Backup: Name: Brian S. Biesman, MD; Phone Number: 615-329-1110; Email: bsbiesman@drbiesman.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Males and females age 25-70
• Mild to moderate jowling and upper eyelid dermatochalasis
• Willingness to participate in the study
• Understand and complete the informed consent, and willingness to complete all visits. -----Women of childbearing age must have a negative pregnancy test and agree to an acceptable form of birth control for the study duration
• Agreement to use all photographs.

Exclusion Criteria:

• Severe laxity, jowling, and subcutaneous fat
• Severe herniated orbital fat, eyelid ptosis, or other eyelid malposition
• Poor skin quality
• History of neuromodulator use in the previous 6 months
• History of dermal filler use in the past 12 months
• Previous blepharoplasty, rhytidectomy, laser skin resurfacing, trauma or facial reconstructive surgery in the treatment area
• Presence of a beard or facial hair which, in the Treating Investigator's opinion, would interfere with the study injections and/or study assessments
• Use of topical facial corticosteroids or prescription retinoids within 1 month of the baseline visit or systemic retinoid treatment within 6 months of the baseline visit
• Presence of any condition, which in the opinion of the Principal Investigator, makes the subject unable to complete the study per protocol or who, in the opinion of the Treating Investigator, should be excluded from the trial.
• History of electronic implanted device, such as, but not limited to, pace maker, internal defibrillator, internal cochlear implant, spinal stimulator, bladder stimulator, etc..
• Currently taking immunosuppressant medications known to interfere with wound healing, response or anti-inflammatory medications (NSAIDS, steroids, other immunosuppressants).
• Patients with underlying diseases that may alter wound healing response (such as diabetes or autoimmune disease).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Thermage; 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.	Device: Thermage FLX; Thermage FLX system for the correction of mild to moderate laxity of the skin of the face, neck, and eyelids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Global Aesthetic Improvement Scale	The subject will make a direct visual assessment to grade the following indications using the below Quartile Improvement Scale: 0 = No improvement, 1 = Minor/Mild Improvement (0.25%), 2 = Moderate Improvement (26-50%), 3 = Marked Improvement (51-75%), 4 = Very Significant Improvement (76-100%) for Skin Laxity, Skin Texture, and Overall Appearance for the upper face, middle face, lower face, and neck.	Month 1, post treatment
Physician Global Aesthetic Improvement Scale	The Investigator will make a direct visual assessment to grade the following indications using the below Quartile Improvement Scale: 0 = No improvement, 1 = Minor/Mild Improvement (0.25%), 2 = Moderate Improvement (26-50%), 3 = Marked Improvement (51-75%), 4 = Very Significant Improvement (76-100%) for Skin Laxity, Skin Texture, and Overall Appearance for the upper face, middle face, lower face, and neck.	Month 1 post treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Global Aesthetic Improvement Scale	The subject will make a direct visual assessment to grade the following indications using the below Quartile Improvement Scale: 0 = No improvement, 1 = Minor/Mild Improvement (0.25%), 2 = Moderate Improvement (26-50%), 3 = Marked Improvement (51-75%), 4 = Very Significant Improvement (76-100%) for Skin Laxity, Skin Texture, and Overall Appearance for the upper face, middle face, lower face, and neck.	Month 3 post treatment
Physician Global Aesthetic Improvement Scale	The Investigator will make a direct visual assessment to grade the following indications using the below Quartile Improvement Scale: 0 = No improvement, 1 = Minor/Mild Improvement (0.25%), 2 = Moderate Improvement (26-50%), 3 = Marked Improvement (51-75%), 4 = Very Significant Improvement (76-100%) for Skin Laxity, Skin Texture, and Overall Appearance for the upper face, middle face, lower face, and neck.	Month 3 post treatment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subject Global Aesthetic Improvement Scale	The subject will make a direct visual assessment to grade the following indications using the below Quartile Improvement Scale: 0 = No improvement, 1 = Minor/Mild Improvement (0.25%), 2 = Moderate Improvement (26-50%), 3 = Marked Improvement (51-75%), 4 = Very Significant Improvement (76-100%) for Skin Laxity, Skin Texture, and Overall Appearance for the upper face, middle face, lower face, and neck.	Month 6 post treatment
Physician Global Aesthetic Improvement Scale	The Investigator will make a direct visual assessment to grade the following indications using the below Quartile Improvement Scale: 0 = No improvement, 1 = Minor/Mild Improvement (0.25%), 2 = Moderate Improvement (26-50%), 3 = Marked Improvement (51-75%), 4 = Very Significant Improvement (76-100%) for Skin Laxity, Skin Texture, and Overall Appearance for the upper face, middle face, lower face, and neck.	Month 6 post treatment

Collaborators and Investigators

• Sponsor: Nashville Centre for Laser and Facial Surgery
• Collaborators: Bausch Health
• Investigators: Principal Investigator: Brian S Biesman, MD, The Practice of Brian S. Biesman, MD

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2019
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: March 25, 2019
• First Submitted That Met QC Criteria: March 26, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): March 28, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Genetic Diseases, Inborn; Connective Tissue Diseases; Skin Diseases, Genetic; Cutis Laxa
• Other Study ID Numbers: 2018-4225

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No