Facial Skin LaxityNCT03894371
Thermage FLX System to Treat the Face, Neck, and Eyelids
A study testing Thermage FLX in people with Facial Skin Laxity, run by Nashville Centre for Laser and Facial Surgery.
Trial 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… Read more about this study
- Who is it for?
- Ages 25 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Skin Laxity
- What is being tested?
- Thermage FLX
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2019to 1 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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
- Being tested
- Thermage FLX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermage FLXDevice
Thermage FLX system for the correction of mild to moderate laxity of the skin of the face, neck, and eyelids.
| Study group | Role | What they receive |
|---|---|---|
| Thermage | Other | 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. Receives: Device: Thermage FLX |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Month 1 post treatment
Secondary outcomes (2)
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.
Measured: 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.
Measured: Month 3 post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 Apr 2019 (estimated)
- Primary completion1 Nov 2019 (estimated)
- Study completion1 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Thermage FLX System
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nashville Centre for Laser and Facial Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Responsible party
- Sponsor
- Investigators
- Brian S Biesman, MD, Principal investigator, The Practice of Brian S. Biesman, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894371
- Sponsor's protocol ID
- 2018-4225
- Status last verified
- Mar 2019
- First submitted
- 25 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thermage FLX System to Treat the Face, Neck, and Eyelids for Correction of Mild to Moderate Skin Laxity.
- ClinicalTrials.gov ID
- NCT03894371
- Acronym / sponsor ID
- 2018-4225
- Conditions
- Facial Skin Laxity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Nashville Centre for Laser and Facial SurgeryUniversity, hospital or other
- Collaborators
- Bausch Health Americas, Inc.
- Study start
- 1 Apr 2019 (estimated)
- Primary completion
- 1 Nov 2019 (estimated)
- Study completion
- 1 Dec 2019 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Thermage FLX System
| Arm | Type | Receives |
|---|---|---|
| Thermage | Other | Device: Thermage FLXSubjects 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. |
Who may qualify
- Ages
- 25 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermage FLXThermage FLX system for the correction of mild to moderate laxity of the skin of the face, neck, and eyelids. | Device | Thermage |
Primary outcome
Subject Global Aesthetic Improvement Scale
Time frame: Month 1, post treatment
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
Time frame: Month 1 post treatment
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.
2 secondary outcomes
Subject Global Aesthetic Improvement Scale
Time frame: Month 3 post treatment
Physician Global Aesthetic Improvement Scale
Time frame: Month 3 post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian S Biesman, MD principal investigator
The Practice of Brian S. Biesman, MD
Questions about this trial
What is this clinical trial studying?
A study testing Thermage FLX in people with Facial Skin Laxity, run by Nashville Centre for Laser and Facial Surgery.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amanda D Spear, CCRC (615329-1110, amanda@drbiesman.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Global Aesthetic Improvement Scale (time frame: Month 1, post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.