Trial Outcomes & Findings for Clinical Assessment of Skin Tightening and Contour Change of Submental Tissue Using Bipolar Radiofrequency Microneedling (NCT NCT04477187)

NCT ID: NCT04477187

Last Updated: 2023-12-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: Month 3 and Month 6 Follow Up
• Results posted on: 2023-12-19

Participant Flow

Participant milestones

Measure	Single Group All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Overall Study STARTED	15
Overall Study COMPLETED	13
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure

Single Group All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.

Overall Study Lost to Follow-up

2

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Single Group n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Fitzpatrick Skin Score Skin Type 1	2 Participants n=5 Participants
Fitzpatrick Skin Score Skin Type 2	8 Participants n=5 Participants
Fitzpatrick Skin Score Skin Type 3	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Month 3 and Month 6 Follow Up

Population: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

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.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Percent Change From Baseline of Soft Tissue Surface Area	-0.18 percent change Standard Deviation 0.89	-017 percent change Standard Deviation 0.32	—

PRIMARY outcome

Timeframe: Month 3 and Month 6 Follow Up

Population: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

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.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Percent Change From Baseline in Volume	-1.30 percent change Standard Deviation 0.68	-1.9 percent change Standard Deviation 1.8	—

PRIMARY outcome

Timeframe: Month 3 and Month 6 Follow Up

Population: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

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.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Percent Change in Minor Tissue Strain	-5.0 percentage change Standard Deviation 2.5	-0.44 percentage change Standard Deviation 0.53	—

PRIMARY outcome

Timeframe: Month 3 and Month 6 Follow Up

Population: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

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.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Percent Change in Horizontal Displacement	-0.55 percent change Standard Deviation 0.99	-0.44 percent change Standard Deviation 0.53	—

PRIMARY outcome

Timeframe: Month 3 and Month 6 Follow Up

Population: 2 subjects withdrew from the study thus only 13 were analyzed at Month 6.

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.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Percent Change in Vertical Displacement	0.04 percent change Standard Deviation 1.06	-0.19 percent change Standard Deviation 0.81	—

SECONDARY outcome

Timeframe: Baseline - 6 Months (Day 180)

Population: Only 11 out of 15 enrolled were analyzed since 2 subjects withdrew and the photos of 2 other subjects were not clear.

Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse)

Outcome measures

Measure	Month 3 Follow Up n=11 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Improvement in Assessments: Global Aesthetic Improvement Score	2.727 units on a scale Standard Deviation 0.49	—	—

SECONDARY outcome

Timeframe: Visit 2 (Day 0- immediately after study procedure)

Immediately after the study procedure, subjects will be asked to rate any pain or discomfort using a 11-point Numerical Pain Rating Scale (0= No pain, 10= Extreme pain)

Outcome measures

Measure	Month 3 Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Subjects Assessment of Pain: Numerical Pain Rating Scale	1.96 score on a scale Interval 0.8 to 3.11	—	—

SECONDARY outcome

Timeframe: Baseline, 3 Month and 6 Month Follow Up

Skin texture and laxity will be assessed using non invasive skin measurements.

Biox Aquaflux- will be used to measure transepidermal water loss.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Non-invasive Measurements: Transepidermal Water Loss Measurements	14.084 g/m^2/h Standard Deviation 3.821	11.095 g/m^2/h Standard Deviation 4.539	14.246 g/m^2/h Standard Deviation 6.661

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 Months (Day 180)

Skin texture and laxity will be assessed using non invasive skin measurements. Skin laxity and elasticity are measured using the Biomechanical Tissue Characterization System.

Optical coherence tomography (OCT) will be used to topographical and histological images of pre- and post-treated skin.

Ra, is the average measurement of skin curvatures and takes into all account variances in the skin roughness profile from the center line.

Rz, is the difference between the highest and lowest data points from the mean surface measurement.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz] Ra (arithmetic mean roughness)	0.015 mm Standard Deviation 0.004	0.014 mm Standard Deviation 0.004	0.014 mm Standard Deviation 0.005
Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz] Rz (Average depth of roughness)	0.105 mm Standard Deviation 0.027	0.1 mm Standard Deviation 0.028	0.095 mm Standard Deviation 0.028

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 Months (Day 180)

Skin texture and laxity will be assessed using non invasive skin measurements.

Optical coherence tomography (OCT) will be used to topographical and histological images of pre- and post-treated skin.

Attenuation coefficient (AC) is a measure of the decay of light intensity within the sample due to absorption and scattering.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Non-invasive Measurements: Optical Coherence Tomography (OCT): Attenuation Coefficient	4.145 mm-1 Standard Deviation 0.765	3.748 mm-1 Standard Deviation 0.674	3.661 mm-1 Standard Deviation 0.42

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Skin laxity and elasticity will be assessed using non invasive skin measurements.

Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin laxity, elasticity.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity) Laxity	1.772 mm Standard Deviation 0.751	1.397 mm Standard Deviation 0.624	1.197 mm Standard Deviation 0.547
Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity) Elasticity	0.997 mm Standard Deviation 0.4	1.053 mm Standard Deviation 0.356	0.808 mm Standard Deviation 0.387

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Skin Elastic, Viscoelastic and Ultimate Deformation will be assessed using non invasive skin measurements.

Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin Elastic, Viscoelastic and Ultimate Deformation.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) Elastic Deformation	3.317 mm Standard Deviation 4.227	1.947 mm Standard Deviation 0.591	1.718 mm Standard Deviation 0.662
Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) Viscoelastic Deformation	0.098 mm Standard Deviation 0.044	0.091 mm Standard Deviation 0.047	0.087 mm Standard Deviation 0.043
Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) Ultimate Deformation	2.316 mm Standard Deviation 0.819	2.038 mm Standard Deviation 0.621	1.805 mm Standard Deviation 0.686

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Skin stiffness will be assessed using non invasive skin measurements.

Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin stiffness.

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Non-invasive Measurements : Biomechanical Tissue Measurements (Stiffness)	205.129 mmHg/mm Standard Deviation 50.702	208.689 mmHg/mm Standard Deviation 46.586	210.836 mmHg/mm Standard Deviation 74.519

SECONDARY outcome

Timeframe: Baseline, Month 3, Month 6

Energy absorption will be assessed using non invasive skin measurements.

Bio-Mechanical Tissue Characterization (BTC2000)- will be used to measure skin laxity values of the skin. This is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin - Energy absorption

Outcome measures

Measure	Month 3 Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=15 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up n=13 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Non-invasive Measurements : Biomechanical Tissue Measurements (Energy Absorption)	78.583 mmHg*mm Standard Deviation 19.482	74.724 mmHg*mm Standard Deviation 21.76	76.425 mmHg*mm Standard Deviation 29.84

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Inconsistency in the analyzed patients was due to study staff unable to obtain a usable sample during visit.

Biopsies collected from subjects will be analyzed to observe changes from baseline to Month 3. Gene Expression studies cellular activity and Col1, Col3, ELN, Lox, IL8 are all biomarkers.

Fold Changes were compared to control and calculated from Ct values of RT-qPCR reactions.

• Ct: threshold cycle
• RT-qPCR: Quantitative reverse transcription polymerase chain reaction)

Outcome measures

Measure	Month 3 Follow Up n=7 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Change in Gene Expression at Month 3 Col1	1.18 fold change Standard Error 0.26	—	—
Change in Gene Expression at Month 3 Col3	1.46 fold change Standard Error 0.42	—	—
Change in Gene Expression at Month 3 ELN	1.27 fold change Standard Error 0.40	—	—
Change in Gene Expression at Month 3 Lox	1.81 fold change Standard Error 0.39	—	—
Change in Gene Expression at Month 3 IL8	1.81 fold change Standard Error 5.46	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: Inconsistency in the analyzed patients was due to study staff unable to obtain a usable sample during visit.

Biopsies collected from subjects will be analyzed to observe changes from baseline to Month 6 . Gene Expression studies cellular activity and Col1, Col3, ELN, Lox, IL8 are all biomarkers.

Fold Changes were compared to control and calculated from Ct values of RT-qPCR reactions.

• Ct: threshold cycle
• RT-qPCR: Quantitative reverse transcription polymerase chain reaction)

Outcome measures

Measure	Month 3 Follow Up n=7 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Change in Gene Expression at Month 6 Col1	6.28 fold change Standard Error 5.56	—	—
Change in Gene Expression at Month 6 Col3	9.99 fold change Standard Error 5.56	—	—
Change in Gene Expression at Month 6 ELN	2.62 fold change Standard Error 0.79	—	—
Change in Gene Expression at Month 6 Lox	9.24 fold change Standard Error 8.56	—	—
Change in Gene Expression at Month 6 IL8	9.24 fold change Standard Error 8.56	—	—

SECONDARY outcome

Timeframe: Baseline, Month 3

Population: Inconsistency in the analyzed patients was due to study staff unable to obtain a usable sample during visit.

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

Dermal Handpiece: 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.

Fold changes were compared to control and were calculated from fluorescence intensity of a confocal microscopy images.

Histology studies the structure of the tissue. Col3, Col1, ELN, Macrophage are biomarkers.

Outcome measures

Measure	Month 3 Follow Up n=7 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Change in Histology at Month 3 Col3	1.24 fold change Standard Error 0.12	—	—
Change in Histology at Month 3 Col1	0.98 fold change Standard Error 5.77	—	—
Change in Histology at Month 3 ELN	1.21 fold change Standard Error 0.13	—	—
Change in Histology at Month 3 Macrophage	0.92 fold change Standard Error 4.38	—	—

SECONDARY outcome

Timeframe: Baseline, Month 6

Population: Inconsistency in the analyzed patients was due to study staff unable to obtain a usable sample during visit.

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

Dermal Handpiece: 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.

Histology studies the structure of the tissue. Col3, Col1, ELN, Macrophage are biomarkers.

Outcome measures

Measure	Month 3 Follow Up n=7 Participants All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.	6 Month Follow Up All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. Dermal Handpiece: 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.
Change in Histology at Month 6 Col3	1.04 fold change Standard Error 0.16	—	—
Change in Histology at Month 6 Col1	0.93 fold change Standard Error 5.04	—	—
Change in Histology at Month 6 ELN	0.98 fold change Standard Error 0.18	—	—
Change in Histology at Month 6 Macrophage	0.89 fold change Standard Error 5.55	—	—

Adverse Events

Single Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Research Coordinator

UT Southwestern

Phone: 214-645-8907

Email: jennifer.barillas@utsouthwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place