Thermage FLX System to Treat the Face, Neck, and Eyelids (NCT03894371) | Clinical Trial Compass
UnknownNot Applicable
Thermage FLX System to Treat the Face, Neck, and Eyelids
25 participantsStarted 2019-04-01
Plain-language 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.
Who can participate
Age range25 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 implan…
What they're measuring
1
Subject Global Aesthetic Improvement Scale
Timeframe: Month 1, post treatment
2
Physician Global Aesthetic Improvement Scale
Timeframe: Month 1 post treatment
Trial details
NCT IDNCT03894371
SponsorNashville Centre for Laser and Facial Surgery