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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Skin Laxity

Intervention / Treatment
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* Device: Dermal Handpiece


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Group<br>All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. | Device: Dermal Handpiece<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Assessments: Global Aesthetic Improvement Score | Blinded reviewers will assessment and score using a 5-point Global Aesthetic Improvement Score (1=Very Much Improved, 5= worse) | Baseline - 6 Months (Day 180) | 
| Subjects Assessment of Pain: Numerical Pain Rating Scale | 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) | Visit 2 (Day 0- immediately after study procedure) | 
| Non-invasive Measurements: Transepidermal Water Loss Measurements | Skin texture and laxity will be assessed using non invasive skin measurements. Biox Aquaflux- will be used to measure transepidermal water loss. | Baseline, 3 Month and 6 Month Follow Up | 
| Non-invasive Measurements: Optical Coherence Tomography (OCT) : [Ra, Rz] | 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. | Baseline, 3 months, 6 Months (Day 180) | 
| Non-invasive Measurements: Optical Coherence Tomography (OCT): Attenuation Coefficient | 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. | Baseline, 3 months, 6 Months (Day 180) | 
| Non-invasive Measurements : Biomechanical Tissue Measurements (Laxity, Elasticity) | 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. | Baseline, Month 3, Month 6 | 
| Non-invasive Measurements : Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | 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. | Baseline, Month 3, Month 6 | 
| Non-invasive Measurements : Biomechanical Tissue Measurements (Stiffness) | 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. | Baseline, Month 3, Month 6 | 
| Non-invasive Measurements : Biomechanical Tissue Measurements (Energy Absorption) | 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 | Baseline, Month 3, Month 6 | 
| Change in Gene Expression at 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) | Baseline, Month 3 | 
| Change in Gene Expression at 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) | Baseline, Month 6 | 
| Change in Histology at 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. | Baseline, Month 3 | 
| Change in Histology at 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. | Baseline, Month 6 |