Bausch Health Thermage FXL for Use on Lower Face and Submentum Area (NCT04606368) | Clinical Trial Compass
CompletedNot Applicable
Bausch Health Thermage FXL for Use on Lower Face and Submentum Area
United States12 participantsStarted 2020-09-29
Plain-language summary
This study is designed to evaluate the safety and efficacy of sequential use of monopolar radiofrequency on lower face and submental area, followed by cryolipolysis on the submentum and submandibular area for fat reduction and improvement of skin laxity.
Who can participate
Age range40 Years – 80 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:
* Female subjects \> 40 years of age and \< 80 years of age.
* Presence of mild to moderate skin laxity on lower face and submentum area, which in the investigator's opinion may benefit from monopolar radiofrequency to improve the skin laxity for a youthful, rejuvenated appearance.
* BMI under 35.
* Agreement to maintain their weight within 5 lb of the baseline.
* Subject has read and signed a written informed consent form.
Exclusion Criteria:
* Subject has severe skin laxity in the area of intended treatment which in the opinion of the investigator, may result in an unacceptable aesthetic result.
* Subject has had a surgical procedure(s) in the area of intended treatment.
* History of a fat reduction procedure (e.g., liposuction, surgery, lipolytic agents, etc.), in or around the area of intended treatment.
* Subject needs to administer, or has a known history of subcutaneous injections into the area of intended treatment (e.g., heparin, insulin) within the past month.
* Currently taking or has taken diet pills or weight control supplements within the past month.
* Any dermatological conditions, such as scars, infection, in the location of the treatment area that may interfere with the treatment or evaluation.
* Active implanted device such as a pacemaker, defibrillator, or drug delivery system.
* Pregnant or intending to become pregnant in the next 6 months.
* Lactating or has been lactating in the past 6 months.
* BMI ≥ 35.
* Unable or unwilling to c…
What they're measuring
1
Incidence of treatment-emergent Adverse Events [Safety and Tolerability]