Trial Outcomes & Findings for Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments (NCT NCT05085730)
NCT ID: NCT05085730
Last Updated: 2023-10-31
Results Overview
Lemperle Wrinkle Assessment Scale- wrinkling will be assessed according to scales definitions. 0- No wrinkles 1. Just perceptible wrinkles 2. Shallow wrinkles 3. Moderately thick wrinkles 4. Deep wrinkles, well defined edges 5. Very deep wrinkles, redundant folds Lower value would indicate improvement.
COMPLETED
NA
13 participants
Baseline, 3 Months and 6 Months
2023-10-31
Participant Flow
Participant milestones
| Measure |
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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Overall Study
STARTED
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13
|
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Overall Study
COMPLETED
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8
|
|
Overall Study
NOT COMPLETED
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5
|
Reasons for withdrawal
| Measure |
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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|---|---|
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Overall Study
Withdrawal by Subject
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4
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|
Overall Study
Physician Decision
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1
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Baseline Characteristics
Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments
Baseline characteristics by cohort
| Measure |
Treatment
n=13 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
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13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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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
|
13 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
|
PRIMARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsLemperle Wrinkle Assessment Scale- wrinkling will be assessed according to scales definitions. 0- No wrinkles 1. Just perceptible wrinkles 2. Shallow wrinkles 3. Moderately thick wrinkles 4. Deep wrinkles, well defined edges 5. Very deep wrinkles, redundant folds Lower value would indicate improvement.
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
Month 6
n=8 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.
|
|---|---|---|---|
|
Change of Fine Lines and Wrinkles
Nasolabial Fold
|
1.25 score on a scale
Standard Deviation 0.71
|
1.625 score on a scale
Standard Deviation 1.06
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1 score on a scale
Standard Deviation 0.93
|
|
Change of Fine Lines and Wrinkles
Upper Lip Lines
|
1.56 score on a scale
Standard Deviation 0.50
|
1.75 score on a scale
Standard Deviation 0.89
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1.125 score on a scale
Standard Deviation 0.64
|
|
Change of Fine Lines and Wrinkles
Corner of Mouth Lines
|
2.13 score on a scale
Standard Deviation 1.36
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1.5 score on a scale
Standard Deviation 1.20
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1.25 score on a scale
Standard Deviation 1.04
|
|
Change of Fine Lines and Wrinkles
Marionette Lines
|
1.25 score on a scale
Standard Deviation 1.39
|
1.31 score on a scale
Standard Deviation 1.03
|
1.06 score on a scale
Standard Deviation 1.08
|
|
Change of Fine Lines and Wrinkles
Lower Lip Line
|
1.06 score on a scale
Standard Deviation 0.56
|
1.25 score on a scale
Standard Deviation 0.89
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0.5 score on a scale
Standard Deviation 0.53
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PRIMARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsAllergan Scale for Fine Lines- fine lines of the midface/cheeks will be assessed according to the scales definition. 0- None 1. Minimal (1-2 superficial lines) 2. Moderate (3-5 superficial lines) 3. Severe (\<5 superficial lines; no crosshatching) 4. Diffuse (diffuse superficial lines; crosshatching) Lower value would indicate improvement
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
Month 6
n=8 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.
|
|---|---|---|---|
|
Change of Fine Lines
|
1.625 score on a scale
Standard Deviation 0.518
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2 score on a scale
Standard Deviation 0.532
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1.375 score on a scale
Standard Deviation 0.916
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PRIMARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsAllergan 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) 1. Minimal (slightly course and uneven visual skin texture) 2. Moderate (Moderately coarse and uneven visual skin texture; early elastosis) 3. Severe (severe coarse visual skin texture, crosshatching lines; some elastosis) 4. Diffuse (extreme coarse visual skin texture, deep crosshatched creases; extreme elastosis) Lower value would indicate improvement
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
Month 6
n=8 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.
|
|---|---|---|---|
|
Change of Skin Roughness
|
1.25 score on a scale
Standard Deviation 0.71
|
0.5 score on a scale
Standard Deviation 0.76
|
0.38 score on a scale
Standard Deviation 0.75
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PRIMARY outcome
Timeframe: 3 Months and 6 MonthsScale will be used to assess aesthetic change 1. Very much improved 2. Much improved 3. Improved 4. No Change 5. Worse Lower value would indicate improvement
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
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.
|
|---|---|---|---|
|
Global Aesthetic Improvement Scale (GAIS)
Clinician GAIS (Live Assessment)
|
3.81 units on a scale
Standard Deviation 0.84
|
2.38 units on a scale
Standard Deviation 1.06
|
—
|
|
Global Aesthetic Improvement Scale (GAIS)
Subject GAIS (Live Assessment)
|
2.88 units on a scale
Standard Deviation 0.99
|
2.63 units on a scale
Standard Deviation 1.06
|
—
|
|
Global Aesthetic Improvement Scale (GAIS)
Clinician GAS (Photo Assessment)
|
3.81 units on a scale
Standard Deviation 0.55
|
3.25 units on a scale
Standard Deviation 0.57
|
—
|
SECONDARY outcome
Timeframe: Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6Adverse events will be monitored at each visit
Outcome measures
| Measure |
Baseline
n=13 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.
|
Month 3
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.
|
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.
|
|---|---|---|---|
|
Adverse Events
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsPopulation: 13 pts originally enrolled in the study- 5 subjects withdrew consent.
high resolution ultrasound will be utilized to assess skin thickness/density.
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
Month 6
n=8 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.
|
|---|---|---|---|
|
Change in Exploratory Thickness/Density- High Resolution Ultrasound
Epidermal Thickness
|
72 μm
Standard Deviation 7.07
|
82.67 μm
Standard Deviation 15.02
|
73 μm
Standard Deviation 8.90
|
|
Change in Exploratory Thickness/Density- High Resolution Ultrasound
Epidermal Density
|
69.53 μm
Standard Deviation 11.02
|
73.30 μm
Standard Deviation 38.51
|
79.65 μm
Standard Deviation 19.43
|
|
Change in Exploratory Thickness/Density- High Resolution Ultrasound
Dermal Thickness
|
1257.33 μm
Standard Deviation 351.80
|
1214.83 μm
Standard Deviation 186.151
|
1311.33 μm
Standard Deviation 175.08
|
|
Change in Exploratory Thickness/Density- High Resolution Ultrasound
Dermal Density
|
10.94 μm
Standard Deviation 4.88
|
17.18 μm
Standard Deviation 11.54
|
21.32 μm
Standard Deviation 9.66
|
SECONDARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
Baseline
n=7 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.
|
Month 3
n=7 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.
|
Month 6
n=7 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.
|
|---|---|---|---|
|
Change in Barrier Skin Function- TEWL
|
26.16 g/m^2/h
Standard Deviation 4.97
|
22.51 g/m^2/h
Standard Deviation 6.87
|
18.08 g/m^2/h
Standard Deviation 2.81
|
SECONDARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsPopulation: Overall 13 pts consented for this study but 5 withdrew consent.
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.
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
Month 6
n=8 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.
|
|---|---|---|---|
|
Biomechanical Tissue Measurements (Laxity, Elasticity)
Laxity
|
1.05 mm/%
Standard Deviation 0.40
|
0.66 mm/%
Standard Deviation 0.33
|
0.89 mm/%
Standard Deviation 0.29
|
|
Biomechanical Tissue Measurements (Laxity, Elasticity)
Elasticity
|
0.69 mm/%
Standard Deviation 0.24
|
0.54 mm/%
Standard Deviation 0.22
|
0.54 mm/%
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsPopulation: Overall 13 pts consented for this study but 5 withdrew consent.
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.
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
Month 6
n=8 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.
|
|---|---|---|---|
|
Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Elastic Deformation
|
1.57 mm
Standard Deviation 0.43
|
1.1 mm
Standard Deviation 0.36
|
1.23 mm
Standard Deviation 0.31
|
|
Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Viscoelastic Deformation
|
0.10 mm
Standard Deviation 0.03
|
0.07 mm
Standard Deviation 0.02
|
0.07 mm
Standard Deviation 0.02
|
|
Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Ultimate Deformation
|
1.66 mm
Standard Deviation 0.45
|
1.17 mm
Standard Deviation 0.36
|
1.34 mm
Standard Deviation 0.32
|
SECONDARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsPopulation: Overall 13 pts consented for this study but 5 withdrew consent.
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.
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
Month 6
n=8 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.
|
|---|---|---|---|
|
Biomechanical Tissue Measurements (Stiffness)
|
189.52 mmHg/mm
Standard Deviation 41.19
|
225.82 mmHg/mm
Standard Deviation 66.99
|
226.44 mmHg/mm
Standard Deviation 44.07
|
SECONDARY outcome
Timeframe: Baseline, 3 Months and 6 MonthsPopulation: Overall 13 pts consented for this study but 5 withdrew consent.
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.
Outcome measures
| Measure |
Baseline
n=8 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.
|
Month 3
n=8 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.
|
Month 6
n=8 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.
|
|---|---|---|---|
|
Biomechanical Tissue Measurements (Energy Absorption)
|
74.32 mmHg*mm
Standard Deviation 17.30
|
59.69 mmHg*mm
Standard Deviation 15.78
|
61.04 mmHg*mm
Standard Deviation 14.22
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsGene 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. * Ct: threshold cycle * RT-qPCR: Quantitative reverse transcription polymerase chain reaction)
Outcome measures
| Measure |
Baseline
n=4 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.
|
Month 3
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.
|
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.
|
|---|---|---|---|
|
Change in Gene Expression
Collagen 1
|
1.16 fold change
Standard Error 0.28
|
—
|
—
|
|
Change in Gene Expression
Collagen 3
|
0.62 fold change
Standard Error 0.42
|
—
|
—
|
|
Change in Gene Expression
Elastin
|
1.72 fold change
Standard Error 0.63
|
—
|
—
|
|
Change in Gene Expression
LOX
|
1.06 fold change
Standard Error 0.71
|
—
|
—
|
|
Change in Gene Expression
IL8
|
0.24 fold change
Standard Error 0.18
|
—
|
—
|
|
Change in Gene Expression
MMP2
|
2.78 fold change
Standard Error 1.98
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 6 MonthsHistological 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.
Outcome measures
| Measure |
Baseline
n=6 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.
|
Month 3
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.
|
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.
|
|---|---|---|---|
|
Change in Histology Assessments
Collagen 3
|
37.82 fold change
Standard Error 7.19
|
—
|
—
|
|
Change in Histology Assessments
Collagen 1
|
7.22 fold change
Standard Error 1.63
|
—
|
—
|
|
Change in Histology Assessments
Elastin
|
32.28 fold change
Standard Error 5.98
|
—
|
—
|
|
Change in Histology Assessments
Macrophage
|
7.49 fold change
Standard Error 1.73
|
—
|
—
|
Adverse Events
Treatment
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place