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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04477187

Enrollment

Registered

2020-07-20

Start date

2020-10-01

Completion date

2022-12-22

Last updated

2023-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Skin Laxity

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.

Detailed description

This is a single-center, unblinded, non-randomized, non-controlled study designed to follow a total of up to 15 qualified and consenting subjects to receive one bipolar fractional radiofrequency microneedling treatment under an IRB approved protocol. Up to 15 subjects will be enrolled and treated at UT Southwestern in the Department of Plastic Surgery. Subjects will be identified from the clinical practice of Dr. Jeffrey Kenkel, Department of Plastic Surgery.

Interventions

DEVICEDermal 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 70 Years

Healthy volunteers

Yes

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 months. * Use of topical retinoids within 48 hours. * Use of prescription anticoagulants. * Pacemaker or internal defibrillator. * History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin). * Subjects on current oral corticosteroid therapy or within the past 6 months * Metal implants in the treatment area. * In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits. * Subjects with a history of radiation therapy to the treatment area. * Subject has a history of allergy to lidocaine or ester-based local anesthetics. * Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine. * Subjects with any skin pathology or condition in the treatment area that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments (e.g. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation). * Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator. * Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year. * Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area. * Subjects have undergone laser and light treatments in the treatment area over the past 3 months. * Subjects have undergone superficial peel or microdermabrasion within 4 weeks.

Design outcomes

Primary

Measure	Time frame	Description
Percent Change in Minor Tissue Strain	Month 3 and Month 6 Follow Up	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.
Percent Change From Baseline of Soft Tissue Surface Area	Month 3 and Month 6 Follow Up	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.
Percent Change From Baseline in Volume	Month 3 and Month 6 Follow Up	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.
Percent Change in Horizontal Displacement	Month 3 and Month 6 Follow Up	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.
Percent Change in Vertical Displacement	Month 3 and Month 6 Follow Up	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.

Secondary

Measure	Time frame	Description
Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity)	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.
Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)	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.
Non-invasive Measurements : Biomechanical Tissue Measurements (Stiffness)	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.
Non-invasive Measurements : Biomechanical Tissue Measurements (Energy Absorption)	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
Improvement in Assessments: Global Aesthetic Improvement Score	Baseline - 6 Months (Day 180)	Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse)
Change in Gene Expression at Month 6	Baseline, Month 6	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)
Change in Histology at Month 3	Baseline, Month 3	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.
Change in Histology at Month 6	Baseline, Month 6	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.
Change in Gene Expression at Month 3	Baseline, Month 3	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)
Subjects Assessment of Pain: Numerical Pain Rating Scale	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)
Non-invasive Measurements: Transepidermal Water Loss Measurements	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.
Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz]	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.
Non-invasive Measurements: Optical Coherence Tomography (OCT): Attenuation Coefficient	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
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.	15
Total	15

Arm

Count

Single Group

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Lost to Follow-up	2

Baseline characteristics

Characteristic	Single Group
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	0 Participants
Age, Categorical Between 18 and 65 years	15 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants
Fitzpatrick Skin Score Skin Type 1	2 Participants
Fitzpatrick Skin Score Skin Type 2	8 Participants
Fitzpatrick Skin Score Skin Type 3	5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants
Race (NIH/OMB) White	15 Participants
Sex: Female, Male Female	14 Participants
Sex: Female, Male Male	1 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 13
other Total, other adverse events	0 / 13
serious Total, serious adverse events	0 / 13

Outcome results

Primary

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.