Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling

NCT04477187 | Completed Results FDA Device

• 1 other identifier: STU-2020-0593
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Skin Laxity

Outcome Measures

Primary Outcomes (5)

• Percent Change From Baseline of Soft Tissue Surface Area

  3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

  Month 3 and Month 6 Follow Up

• Percent Change From Baseline in Volume

  3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

  Month 3 and Month 6 Follow Up

• Percent Change in Minor Tissue Strain

  Percent change in Minor Tissue Strain is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

  Month 3 and Month 6 Follow Up

• Percent Change in Horizontal Displacement

  Percent change in Horizontal Displacement is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

  Month 3 and Month 6 Follow Up

• Percent Change in Vertical Displacement

  Percent change in Vertical Displacement is measured using the Markerless Tracking feature on Canfield's H2 3D Imaging System. 3D stereophotogrammetry measurements obtained at Follow Up visits and compared to baseline measurements. Percent change from baseline was calculated from baseline for both Month 3 and Month 6.

  Month 3 and Month 6 Follow Up

Secondary Outcomes (13)

• Improvement in Assessments: Global Aesthetic Improvement Score

  Baseline - 6 Months (Day 180)

• Subjects Assessment of Pain: Numerical Pain Rating Scale

  Visit 2 (Day 0- immediately after study procedure)

• Non-invasive Measurements: Transepidermal Water Loss Measurements

  Baseline, 3 Month and 6 Month Follow Up

• Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz]

  Baseline, 3 months, 6 Months (Day 180)

• Non-invasive Measurements: Optical Coherence Tomography (OCT): Attenuation Coefficient

  Baseline, 3 months, 6 Months (Day 180)

Study Arms (1)

Single Group

EXPERIMENTAL

All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece.

Device: Dermal Handpiece

Interventions

Dermal Handpiece DEVICE

Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.

Single Group

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 months.
• Use of topical retinoids within 48 hours.
• Use of prescription anticoagulants.
• Pacemaker or internal defibrillator.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center- Dept of Plastic Surgery

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Results Point of Contact

• Title: Research Coordinator
• Organization: UT Southwestern

jennifer.barillas@utsouthwestern.edu

214-645-8907

Study Officials

• Jeffrey Kenkel, MD

  UT Southwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair Department of Plastic Surgery

Study Record Dates

• First Submitted: July 8, 2020
• First Posted: July 20, 2020
• Study Start: October 1, 2020
• Primary Completion: June 13, 2022
• Study Completion: December 22, 2022
• Last Updated: December 19, 2023
• Results First Posted: December 19, 2023

Record last verified: 2023-11

Locations

US (1)