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This study intends to evaluate the safety and effectiveness of the InMode Morpheus8 System to treat facial and neck skin and assess its effect on skin quality and dermal lines. This device has been FDA cleared for full body subdermal adipose tissue remodeling.
The primary objective of this study is to evaluate the safety and efficacy of a bipolar fractional radiofrequency treatment via use of the InMode Morpheus8 System to achieve skin texture and quality change and to treat facial fine lines and wrinkles of the lower face.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | All subjects will receive 4 separate treatments with the InMode Morpheus8 System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InMode Morpheus8 System | Device | The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Fine Lines and Wrinkles | Lemperle Wrinkle Assessment Scale- wrinkling will be assessed according to scales definitions. 0- No wrinkles
Lower value would indicate improvement. | Baseline, 3 Months and 6 Months |
| Change of Fine Lines | Allergan Scale for Fine Lines- fine lines of the midface/cheeks will be assessed according to the scales definition. 0- None
Lower value would indicate improvement | Baseline, 3 Months and 6 Months |
| Change of Skin Roughness | Allergan Skin Roughness Scale Assessment- roughness will be assessed according to the scaled definitions based on skin coarseness, crosshatching and elastosis in midface area. 0- None (smooth visual skin texture)
Lower value would indicate improvement | Baseline, 3 Months and 6 Months |
| Global Aesthetic Improvement Scale (GAIS) | Scale will be used to assess aesthetic change
Lower value would indicate improvement | 3 Months and 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Adverse events will be monitored at each visit | Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6 |
| Change in Exploratory Thickness/Density- High Resolution Ultrasound | high resolution ultrasound will be utilized to assess skin thickness/density. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Kenkel, MD | UT Southwestern- Department of Plastic Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment | All subjects will receive 4 separate treatments with the InMode Morpheus8 System. InMode Morpheus8 System: The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment | All subjects will receive 4 separate treatments with the InMode Morpheus8 System. InMode Morpheus8 System: The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis. |
| 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 | Change of Fine Lines and Wrinkles | Lemperle Wrinkle Assessment Scale- wrinkling will be assessed according to scales definitions. 0- No wrinkles
Lower value would indicate improvement. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months and 6 Months |
|
Data was collected in a 6 month period after first treatment was completed
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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 | Treatment | All subjects will receive 4 separate treatments with the InMode Morpheus8 System. InMode Morpheus8 System: The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis. |
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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 | Nov 17, 2022 | Jun 28, 2023 | Prot_SAP_001.pdf |
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| Baseline, 3 Months and 6 Months |
| Change in Barrier Skin Function- TEWL | Transepidermal Water Loss Measurements (TEWL measurements) (via Bio Aquaflux) will be used to evaluate barrier function of the skin epidermal layer after treatments. It is used to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. Skin barrier dysfunction results in increased TEWL. | Baseline, 3 Months and 6 Months |
| Biomechanical Tissue Measurements (Laxity, Elasticity) | Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. | Baseline, 3 Months and 6 Months |
| Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. | Baseline, 3 Months and 6 Months |
| Biomechanical Tissue Measurements (Stiffness) | Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. | Baseline, 3 Months and 6 Months |
| Biomechanical Tissue Measurements (Energy Absorption) | Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. | Baseline, 3 Months and 6 Months |
| Change in Gene Expression | Gene expression assessments will be completed to analyze protein related to collagen, elastin, and the extracellular matrix production. Gene Expression studies cellular activity and Collagen 1, Collagen 3, Elastin, LOX, IL8 and MMP2 are all biomarkers. Gene expression was only compared between baseline and 6 months. Fold changes were compared to control from Ct values of RT-qPCR reactions.
| Baseline and 6 Months |
| Change in Histology Assessments | Histological assessments (microscopic study-tissue structure, elastin, collagen and hyaluronic acid expression) will be completed after taking biopsies ( from the cheek adjacent to the nasolabial fold within the designated area for treatment) of the skin area to correlate changes to the skin after treatments. Histology studies the structure of the tissue. Collagen 3, Collagen 1, Elastin, Macrophage are biomarkers. Histology was only compared between baseline and 6 months. Fold changes compared to control were calculated from fluorescence intensity of a confocal microscopy images. | Baseline and 6 Months |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
All subjects will receive 4 separate treatments with the InMode Morpheus8 System.
InMode Morpheus8 System: The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis.
| OG002 | Month 6 | All subjects will receive 4 separate treatments with the InMode Morpheus8 System. InMode Morpheus8 System: The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis. |
|
|
| Primary | Change of Fine Lines | Allergan Scale for Fine Lines- fine lines of the midface/cheeks will be assessed according to the scales definition. 0- None
Lower value would indicate improvement | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months and 6 Months |
|
|
|
| Primary | Change of Skin Roughness | Allergan Skin Roughness Scale Assessment- roughness will be assessed according to the scaled definitions based on skin coarseness, crosshatching and elastosis in midface area. 0- None (smooth visual skin texture)
Lower value would indicate improvement | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 Months and 6 Months |
|
|
|
| Primary | Global Aesthetic Improvement Scale (GAIS) | Scale will be used to assess aesthetic change
Lower value would indicate improvement | Posted | Mean | Standard Deviation | units on a scale | 3 Months and 6 Months |
|
|
|
| Secondary | Adverse Events | Adverse events will be monitored at each visit | Posted | Count of Participants | Participants | Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6 |
|
|
|
| Secondary | Change in Exploratory Thickness/Density- High Resolution Ultrasound | high resolution ultrasound will be utilized to assess skin thickness/density. | 13 pts originally enrolled in the study- 5 subjects withdrew consent. | Posted | Mean | Standard Deviation | μm | Baseline, 3 Months and 6 Months |
|
|
|
| Secondary | Change in Barrier Skin Function- TEWL | Transepidermal Water Loss Measurements (TEWL measurements) (via Bio Aquaflux) will be used to evaluate barrier function of the skin epidermal layer after treatments. It is used to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. Skin barrier dysfunction results in increased TEWL. | Overall 13 pts enrolled in the study and 5 withdrew consent. An additional subject did not have a measurement obtained during their final visit thus was excluded from the analysis. | Posted | Mean | Standard Deviation | g/m^2/h | Baseline, 3 Months and 6 Months |
|
|
|
| Secondary | Biomechanical Tissue Measurements (Laxity, Elasticity) | Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. | Overall 13 pts consented for this study but 5 withdrew consent. | Posted | Mean | Standard Deviation | mm/% | Baseline, 3 Months and 6 Months |
|
|
|
| Secondary | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. | Overall 13 pts consented for this study but 5 withdrew consent. | Posted | Mean | Standard Deviation | mm | Baseline, 3 Months and 6 Months |
|
|
|
| Secondary | Biomechanical Tissue Measurements (Stiffness) | Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. | Overall 13 pts consented for this study but 5 withdrew consent. | Posted | Mean | Standard Deviation | mmHg/mm | Baseline, 3 Months and 6 Months |
|
|
|
| Secondary | Biomechanical Tissue Measurements (Energy Absorption) | Bio-Mechanical Tissue Characterization (BTC2000) is a laser measurement system for objective, quantitative and sensitive analyses of the bio-mechanical properties of: Skin to assess skin thickness, density, firmness as well as the integrity of the stratum corneum. | Overall 13 pts consented for this study but 5 withdrew consent. | Posted | Mean | Standard Deviation | mmHg*mm | Baseline, 3 Months and 6 Months |
|
|
|
| Secondary | Change in Gene Expression | Gene expression assessments will be completed to analyze protein related to collagen, elastin, and the extracellular matrix production. Gene Expression studies cellular activity and Collagen 1, Collagen 3, Elastin, LOX, IL8 and MMP2 are all biomarkers. Gene expression was only compared between baseline and 6 months. Fold changes were compared to control from Ct values of RT-qPCR reactions.
| Posted | Mean | Standard Error | fold change | Baseline and 6 Months |
|
|
|
| Secondary | Change in Histology Assessments | Histological assessments (microscopic study-tissue structure, elastin, collagen and hyaluronic acid expression) will be completed after taking biopsies ( from the cheek adjacent to the nasolabial fold within the designated area for treatment) of the skin area to correlate changes to the skin after treatments. Histology studies the structure of the tissue. Collagen 3, Collagen 1, Elastin, Macrophage are biomarkers. Histology was only compared between baseline and 6 months. Fold changes compared to control were calculated from fluorescence intensity of a confocal microscopy images. | Posted | Mean | Standard Error | fold change | Baseline and 6 Months |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
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| Clinician GAS (Photo Assessment) |
|
|
| Dermal Thickness |
|
| Dermal Density |
|
|
|
| Ultimate Deformation |
|
| Title | Measurements |
|---|---|
|
| LOX |
|
| IL8 |
|
| MMP2 |
|
| Title | Measurements |
|---|---|
|
| Macrophage |
|