Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radio… (NCT04477187) | Clinical Trial Compass
CompletedNot Applicable
Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling
United States15 participantsStarted 2020-10-01
Plain-language summary
The purpose of this study is to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve skin tightening and contour change in lax submental (beneath the chin) tissue.
Who can participate
Age range21 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:
* Healthy male and female adults between ages 21-70 years of age.
* Desire skin laxity lift of the submental region.
* Confirmed BMI ≤ 35.
* Subjects who can read, understand, and sign the Informed Consent Form.
* Subjects willing and able to comply with all study requirements.
* Fitzpatrick skin type I-VI.
* Submental fat graded by the Investigator as ≥ 1 using the Clinician-Reported Submental Fat Rating Scale
* Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study.
Exclusion Criteria:
* Active localized or systemic infections, that may alter wound healing.
* Immunocompromised subjects.
* Subjects with coagulation disorder.
* History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs).
* Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study).
* Excessive skin laxity on the submental and neck (Submental Skin Laxity Grade: SMSLG 4, Appendix E), or other anatomical feature for which reduction in SMF which may, in the judgment of the investigator, result in an aesthetically unacceptable outcome.
* Scarring in areas to be treated.
* Tattoos in the treatment areas to be treated.
* Significant open facial wounds or lesions.
* Severe or cystic acne in treatment areas.
* Current active smoker.
* Use of Accutane (Isotretinoin) within the past 6 mont…
What they're measuring
1
Percent Change From Baseline of Soft Tissue Surface Area
Timeframe: Month 3 and Month 6 Follow Up
2
Percent Change From Baseline in Volume
Timeframe: Month 3 and Month 6 Follow Up
3
Percent Change in Minor Tissue Strain
Timeframe: Month 3 and Month 6 Follow Up
4
Percent Change in Horizontal Displacement
Timeframe: Month 3 and Month 6 Follow Up
5
Percent Change in Vertical Displacement
Timeframe: Month 3 and Month 6 Follow Up
Trial details
NCT IDNCT04477187
SponsorUniversity of Texas Southwestern Medical Center