Thermage FLX System to Treat the Face, Neck, and Eyelids
Primary Purpose
Facial Skin Laxity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Thermage FLX
Sponsored by
About this trial
This is an interventional treatment trial for Facial Skin Laxity
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Thermage
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03894371
First Posted
March 25, 2019
Last Updated
March 26, 2019
Sponsor
Nashville Centre for Laser and Facial Surgery
Collaborators
Bausch Health
1. Study Identification
Unique Protocol Identification Number
NCT03894371
Brief Title
Thermage FLX System to Treat the Face, Neck, and Eyelids
Official Title
Thermage FLX System to Treat the Face, Neck, and Eyelids for Correction of Mild to Moderate Skin Laxity.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2019 (Anticipated)
Primary Completion Date
November 1, 2019 (Anticipated)
Study Completion Date
December 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nashville Centre for Laser and Facial Surgery
Collaborators
Bausch Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Skin Laxity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Thermage FLX System
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thermage
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Thermage FLX
Intervention Description
Thermage FLX system for the correction of mild to moderate laxity of the skin of the face, neck, and eyelids.
Primary Outcome Measure Information:
Title
Subject Global Aesthetic Improvement Scale
Description
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.
Time Frame
Month 1, post treatment
Title
Physician Global Aesthetic Improvement Scale
Description
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.
Time Frame
Month 1 post treatment
Secondary Outcome Measure Information:
Title
Subject Global Aesthetic Improvement Scale
Description
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.
Time Frame
Month 3 post treatment
Title
Physician Global Aesthetic Improvement Scale
Description
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.
Time Frame
Month 3 post treatment
Other Pre-specified Outcome Measures:
Title
Subject Global Aesthetic Improvement Scale
Description
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.
Time Frame
Month 6 post treatment
Title
Physician Global Aesthetic Improvement Scale
Description
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.
Time Frame
Month 6 post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda D Spear, CCRC
Phone
615329-1110
Email
amanda@drbiesman.com
First Name & Middle Initial & Last Name or Official Title & Degree
Brian S. Biesman, MD
Phone
615-329-1110
Email
bsbiesman@drbiesman.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian S Biesman, MD
Organizational Affiliation
The Practice of Brian S. Biesman, MD
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Thermage FLX System to Treat the Face, Neck, and Eyelids
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