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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Group | Experimental | All subjects will undergo a single treatment for skin laxity in the submentum with a dermal handpiece. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kenkel, MD | UT Southwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT Southwestern Medical Center- Dept of Plastic Surgery | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 2 subjects withdrew from the study thus only 13 were analyzed at Month 6. | Posted | Mean | Standard Deviation | percent change | Month 3 and Month 6 Follow Up |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordinator | UT Southwestern | 214-645-8907 | jennifer.barillas@utsouthwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2022 | Sep 6, 2023 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D003483 | Cutis Laxa |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003240 | Connective Tissue Diseases |
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|
| Month 3 and Month 6 Follow Up |
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.
| 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.
| 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 |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Fitzpatrick Skin Score | Type I (scores 0-6) always burns, never tans (palest; freckles) Type II (scores 7-13) usually burns, tans minimally (light colored but darker than fair) Type III (scores 14-20) sometimes mild burn, tans uniformly (golden honey or olive) | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | 2 subjects withdrew from the study thus only 13 were analyzed at Month 6. | Posted | Mean | Standard Deviation | percent change | Month 3 and Month 6 Follow Up |
|
|
|
| Primary | 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. | 2 subjects withdrew from the study thus only 13 were analyzed at Month 6. | Posted | Mean | Standard Deviation | percentage change | Month 3 and Month 6 Follow Up |
|
|
|
| Primary | 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. | 2 subjects withdrew from the study thus only 13 were analyzed at Month 6. | Posted | Mean | Standard Deviation | percent change | Month 3 and Month 6 Follow Up |
|
|
|
| Primary | 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. | 2 subjects withdrew from the study thus only 13 were analyzed at Month 6. | Posted | Mean | Standard Deviation | percent change | Month 3 and Month 6 Follow Up |
|
|
|
| Secondary | 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) | Only 11 out of 15 enrolled were analyzed since 2 subjects withdrew and the photos of 2 other subjects were not clear. | Posted | Mean | Standard Deviation | units on a scale | Baseline - 6 Months (Day 180) |
|
|
|
| Secondary | 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) | Posted | Mean | 95% Confidence Interval | score on a scale | Visit 2 (Day 0- immediately after study procedure) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | g/m^2/h | Baseline, 3 Month and 6 Month Follow Up |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | Baseline, 3 months, 6 Months (Day 180) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm-1 | Baseline, 3 months, 6 Months (Day 180) |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | Baseline, Month 3, Month 6 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | Baseline, Month 3, Month 6 |
|
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mmHg/mm | Baseline, Month 3, Month 6 |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | mmHg*mm | Baseline, Month 3, Month 6 |
|
|
|
| Secondary | 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.
| Inconsistency in the analyzed patients was due to study staff unable to obtain a usable sample during visit. | Posted | Mean | Standard Error | fold change | Baseline, Month 3 |
|
|
|
| Secondary | 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.
| Inconsistency in the analyzed patients was due to study staff unable to obtain a usable sample during visit. | Posted | Mean | Standard Error | fold change | Baseline, Month 6 |
|
|
|
| Secondary | 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. | Inconsistency in the analyzed patients was due to study staff unable to obtain a usable sample during visit. | Posted | Mean | Standard Error | fold change | Baseline, Month 3 |
|
|
|
| Secondary | 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. | Inconsistency in the analyzed patients was due to study staff unable to obtain a usable sample during visit. | Posted | Mean | Standard Error | fold change | Baseline, Month 6 |
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| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
|
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| Ultimate Deformation |
|
| Title | Measurements |
|---|---|
|
| Lox |
|
| IL8 |
|
| Title | Measurements |
|---|---|
|
| Lox |
|
| IL8 |
|
| Title | Measurements |
|---|---|
|
| Macrophage |
|
| Title | Measurements |
|---|---|
|
| Macrophage |
|