Bipolar RF Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue and Effect… (NCT04245696) | Clinical Trial Compass
WithdrawnNot Applicable
Bipolar RF Microneedling for Improved Laxity and Lift of the Submental and Neck Tissue and Effect on Elastin
Stopped: Business decision, no serious AEs.
United States0Started 2020-03-09
Plain-language summary
This study is being conducted to evaluate the safety and efficacy of bipolar fractional radiofrequency treatment via use of the Profound System to achieve lift in lax submental (beneath the chin) and neck 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 submental and neck regions.
* 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 (CR-SMFRS, 0=Absent (No localized submental fat evidence), 4=Extreme (Extreme submental convexity)
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=Severe, superficial wrinkling present), or other anatomical feature for which reduction in submental fat (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 months.
* Use …
What they're measuring
1
Change in submental skin laxity
Timeframe: Baseline - Day 180 (6 months post-treatment)
2
Occurrence, severity, and relatedness of adverse events
Timeframe: Baseline - Day 180 (6 months post-treatment)