CoolSculpting and RF for the Submental (NCT03873779) | Clinical Trial Compass
CompletedNot Applicable
CoolSculpting and RF for the Submental
United States8 participantsStarted 2018-12-18
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of sequential use of CoolSculpting (Cryolipolysis) and radiofrequency treatment of the submental and submandibular area.
Who can participate
Age range22 Years – 65 Years
SexALL
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Inclusion Criteria
* Male or female subjects ≥22 years of age and ≤65 years of age.
* Treatment area skin fold thickness \> 1cm (measured by caliper).
* Dissatisfaction with the treatment area expressed by the subject as a rating of 0, 1 or 2 using the Subject Self Rating Scale (SSRS) as determined at Screening visit.
* No weight change exceeding 5% of body weight in the preceding month.
* Agreement to maintain his/her weight (i.e., within 5%) by not making any major changes in diet or exercise routine during the course of the study.
* Subject has signed a written informed consent form
Exclusion Criteria
* Body Mass Index ≥ 46.2 as determined at screening.
* Excessive skin laxity in the treatment area for which reduction of subcutaneous fat may, in the opinion of the investigator, result in an unacceptable aesthetic result.
* Prominent platysmal bands at rest which may interfere with assessment of treatment area.
* Evidence of any cause of enlargement in the treatment area other than localized subcutaneous fat, such as swollen lymph nodes or ptotic submandibular glands.
* Significant enlargement on the anterior neck that may prevent the proper placement of the applicator e.g. enlarged thyroid glands.
* Treatment with dermal fillers, chemical peels, radiofrequency or laser procedures that may affect contour in the treatment area within the past 6 months.
* Botulinum toxin, deoxycholic acid, or other aesthetic drug injections within the treatment area in the past 6 months.
*…
What they're measuring
1
Number of Participants With Unanticipated Adverse Device Effects (UADEs)
Timeframe: From date of first treatment to 12 weeks after final treatment (up to 24 weeks)
2
Number of Participants With Global Aesthetic Improvement Per Independent Physician Review of Photographs Based on Investigator Global Aesthetic Improvement Scale (GAIS-Independent)
Timeframe: Baseline, 12 weeks post radiofrequency treatment