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

NCT03894371 | Unknown

• 1 other identifier: 2018-4225
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Facial Skin Laxity

Outcome Measures

Primary 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.

  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 Outcomes (2)

• Subject Global Aesthetic Improvement Scale

  Month 3 post treatment

• Physician Global Aesthetic Improvement Scale

  Month 3 post treatment

Other Outcomes (2)

• Subject Global Aesthetic Improvement Scale

  Month 6 post treatment

• Physician Global Aesthetic Improvement Scale

  Month 6 post treatment

Study Arms (1)

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.

Device: Thermage FLX

Interventions

Thermage FLX DEVICE

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

Thermage

Eligibility Criteria

• Age: 25 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Nashville Centre for Laser and Facial Surgery: lead
• Bausch Health: collaborator

Study Officials

• Brian S Biesman, MD

  The Practice of Brian S. Biesman, MD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda D Spear, CCRC

CONTACT

615329-1110; amanda@drbiesman.com

Brian S. Biesman, MD

CONTACT

615-329-1110; bsbiesman@drbiesman.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Thermage FLX System

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: March 28, 2019
• Study Start: April 1, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 28, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share