Aging
Conditions
Keywords
skin aging, bipolar radiofrequency, microneedling, dermal lines
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInMode Morpheus8 System
The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis.
Sponsors
University of Texas Southwestern Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male and female adults between ages 21-70 years of age. 2. Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure. 3. Confirmed BMI ≤ 35. 4. Subjects who can read, understand, and sign the Informed Consent Form. 5. Subjects willing and able to comply with all study requirements. 6. Fitzpatrick skin type I-VI. 7. Minimum of 1 on the Lemperle Wrinkle Assessment Scale, Allergan Fine Line Scale and Allergan Skin Roughness Scale 8. 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
1. Active localized or systemic infections, that may alter wound healing. 2. Immunocompromised subjects. 3. Subjects with coagulation disorder. 4. History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs). 5. Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study). 6. 5 on the Lemperle Wrinkle Assessment Scale or 4 on the Allergan Fine Line Scale and/or Allergan Skin Roughness Scales 7. Scarring in areas to be treated. 8. Tattoos in the treatment areas to be treated. 9. Significant open facial wounds or lesions. 10. Severe or cystic acne in treatment areas. 11. Current active smoker. 12. Use of Accutane (Isotretinoin) within the past 6 months. 13. Use of topical retinoids within 48 hours. 14. Use of prescription anticoagulants. 15. Pacemaker or internal defibrillator. 16. History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin). 17. Subjects on current oral corticosteroid therapy or within the past 6 months 18. Metal implants in the treatment area. 19. In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits. 20. Subjects with a history of radiation therapy to the treatment area. 21. Subject has a history of allergy to lidocaine or ester-based local anesthetics. 22. Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine. 23. 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). 24. Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator. 25. Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year. 26. Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area. 27. Subjects have undergone laser and light treatments in the treatment area over the past 3 months. 28. Subjects have undergone superficial peel or microdermabrasion within 4 weeks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Fine Lines and Wrinkles | Baseline, 3 Months and 6 Months | 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. |
| Change of Fine Lines | Baseline, 3 Months and 6 Months | Allergan 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 |
| Change of Skin Roughness | Baseline, 3 Months and 6 Months | 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) 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 |
| Global Aesthetic Improvement Scale (GAIS) | 3 Months and 6 Months | Scale 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Baseline, 3 Months and 6 Months | 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. |
| Biomechanical Tissue Measurements (Stiffness) | Baseline, 3 Months and 6 Months | 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. |
| Adverse Events | Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6 | Adverse events will be monitored at each visit |
| Change in Gene Expression | Baseline and 6 Months | 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. * Ct: threshold cycle * RT-qPCR: Quantitative reverse transcription polymerase chain reaction) |
| Change in Histology Assessments | Baseline and 6 Months | 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. |
| Biomechanical Tissue Measurements (Energy Absorption) | Baseline, 3 Months and 6 Months | 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. |
| Change in Exploratory Thickness/Density- High Resolution Ultrasound | Baseline, 3 Months and 6 Months | high resolution ultrasound will be utilized to assess skin thickness/density. |
| Change in Barrier Skin Function- TEWL | Baseline, 3 Months and 6 Months | 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. |
| Biomechanical Tissue Measurements (Laxity, Elasticity) | Baseline, 3 Months and 6 Months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Treatment |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 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 | 13 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 0 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
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 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
Time frame: Baseline, 3 Months and 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change of Fine Lines | 1.625 score on a scale | Standard Deviation 0.518 |
| Month 3 | Change of Fine Lines | 2 score on a scale | Standard Deviation 0.532 |
| Month 6 | Change of Fine Lines | 1.375 score on a scale | Standard Deviation 0.916 |
Primary
Change of Fine Lines and Wrinkles
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.
Time frame: Baseline, 3 Months and 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Change of Fine Lines and Wrinkles | Lower Lip Line | 1.06 score on a scale | Standard Deviation 0.56 |
| Baseline | Change of Fine Lines and Wrinkles | Marionette Lines | 1.25 score on a scale | Standard Deviation 1.39 |
| Baseline | Change of Fine Lines and Wrinkles | Nasolabial Fold | 1.25 score on a scale | Standard Deviation 0.71 |
| Baseline | Change of Fine Lines and Wrinkles | Corner of Mouth Lines | 2.13 score on a scale | Standard Deviation 1.36 |
| Baseline | Change of Fine Lines and Wrinkles | Upper Lip Lines | 1.56 score on a scale | Standard Deviation 0.5 |
| Month 3 | Change of Fine Lines and Wrinkles | Corner of Mouth Lines | 1.5 score on a scale | Standard Deviation 1.2 |
| Month 3 | Change of Fine Lines and Wrinkles | Marionette Lines | 1.31 score on a scale | Standard Deviation 1.03 |
| Month 3 | Change of Fine Lines and Wrinkles | Lower Lip Line | 1.25 score on a scale | Standard Deviation 0.89 |
| Month 3 | Change of Fine Lines and Wrinkles | Nasolabial Fold | 1.625 score on a scale | Standard Deviation 1.06 |
| Month 3 | Change of Fine Lines and Wrinkles | Upper Lip Lines | 1.75 score on a scale | Standard Deviation 0.89 |
| Month 6 | Change of Fine Lines and Wrinkles | Nasolabial Fold | 1 score on a scale | Standard Deviation 0.93 |
| Month 6 | Change of Fine Lines and Wrinkles | Marionette Lines | 1.06 score on a scale | Standard Deviation 1.08 |
| Month 6 | Change of Fine Lines and Wrinkles | Corner of Mouth Lines | 1.25 score on a scale | Standard Deviation 1.04 |
| Month 6 | Change of Fine Lines and Wrinkles | Lower Lip Line | 0.5 score on a scale | Standard Deviation 0.53 |
| Month 6 | Change of Fine Lines and Wrinkles | Upper Lip Lines | 1.125 score on a scale | Standard Deviation 0.64 |
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) 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
Time frame: Baseline, 3 Months and 6 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change of Skin Roughness | 1.25 score on a scale | Standard Deviation 0.71 |
| Month 3 | Change of Skin Roughness | 0.5 score on a scale | Standard Deviation 0.76 |
| Month 6 | Change of Skin Roughness | 0.38 score on a scale | Standard Deviation 0.75 |
Primary
Global Aesthetic Improvement Scale (GAIS)
Scale 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
Time frame: 3 Months and 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Global Aesthetic Improvement Scale (GAIS) | Clinician GAIS (Live Assessment) | 3.81 units on a scale | Standard Deviation 0.84 |
| Baseline | Global Aesthetic Improvement Scale (GAIS) | Subject GAIS (Live Assessment) | 2.88 units on a scale | Standard Deviation 0.99 |
| Baseline | Global Aesthetic Improvement Scale (GAIS) | Clinician GAS (Photo Assessment) | 3.81 units on a scale | Standard Deviation 0.55 |
| Month 3 | Global Aesthetic Improvement Scale (GAIS) | Clinician GAIS (Live Assessment) | 2.38 units on a scale | Standard Deviation 1.06 |
| Month 3 | Global Aesthetic Improvement Scale (GAIS) | Subject GAIS (Live Assessment) | 2.63 units on a scale | Standard Deviation 1.06 |
| Month 3 | Global Aesthetic Improvement Scale (GAIS) | Clinician GAS (Photo Assessment) | 3.25 units on a scale | Standard Deviation 0.57 |
Secondary
Adverse Events
Adverse events will be monitored at each visit
Time frame: Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline | Adverse Events | 0 Participants |
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.
Time frame: Baseline, 3 Months and 6 Months
Population: Overall 13 pts consented for this study but 5 withdrew consent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Viscoelastic Deformation | 0.10 mm | Standard Deviation 0.03 |
| Baseline | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Elastic Deformation | 1.57 mm | Standard Deviation 0.43 |
| Baseline | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Ultimate Deformation | 1.66 mm | Standard Deviation 0.45 |
| Month 3 | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Viscoelastic Deformation | 0.07 mm | Standard Deviation 0.02 |
| Month 3 | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Elastic Deformation | 1.1 mm | Standard Deviation 0.36 |
| Month 3 | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Ultimate Deformation | 1.17 mm | Standard Deviation 0.36 |
| Month 6 | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Elastic Deformation | 1.23 mm | Standard Deviation 0.31 |
| Month 6 | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Ultimate Deformation | 1.34 mm | Standard Deviation 0.32 |
| Month 6 | Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation) | Viscoelastic Deformation | 0.07 mm | Standard Deviation 0.02 |
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.
Time frame: Baseline, 3 Months and 6 Months
Population: Overall 13 pts consented for this study but 5 withdrew consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Biomechanical Tissue Measurements (Energy Absorption) | 74.32 mmHg*mm | Standard Deviation 17.3 |
| Month 3 | Biomechanical Tissue Measurements (Energy Absorption) | 59.69 mmHg*mm | Standard Deviation 15.78 |
| Month 6 | Biomechanical Tissue Measurements (Energy Absorption) | 61.04 mmHg*mm | Standard Deviation 14.22 |
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.
Time frame: Baseline, 3 Months and 6 Months
Population: Overall 13 pts consented for this study but 5 withdrew consent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Biomechanical Tissue Measurements (Laxity, Elasticity) | Laxity | 1.05 mm/% | Standard Deviation 0.4 |
| Baseline | Biomechanical Tissue Measurements (Laxity, Elasticity) | Elasticity | 0.69 mm/% | Standard Deviation 0.24 |
| Month 3 | Biomechanical Tissue Measurements (Laxity, Elasticity) | Laxity | 0.66 mm/% | Standard Deviation 0.33 |
| Month 3 | Biomechanical Tissue Measurements (Laxity, Elasticity) | Elasticity | 0.54 mm/% | Standard Deviation 0.22 |
| Month 6 | Biomechanical Tissue Measurements (Laxity, Elasticity) | Laxity | 0.89 mm/% | Standard Deviation 0.29 |
| Month 6 | Biomechanical Tissue Measurements (Laxity, Elasticity) | Elasticity | 0.54 mm/% | Standard Deviation 0.23 |
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.
Time frame: Baseline, 3 Months and 6 Months
Population: Overall 13 pts consented for this study but 5 withdrew consent.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Biomechanical Tissue Measurements (Stiffness) | 189.52 mmHg/mm | Standard Deviation 41.19 |
| Month 3 | Biomechanical Tissue Measurements (Stiffness) | 225.82 mmHg/mm | Standard Deviation 66.99 |
| Month 6 | Biomechanical Tissue Measurements (Stiffness) | 226.44 mmHg/mm | Standard Deviation 44.07 |
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.
Time frame: Baseline, 3 Months and 6 Months
Population: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Change in Barrier Skin Function- TEWL | 26.16 g/m^2/h | Standard Deviation 4.97 |
| Month 3 | Change in Barrier Skin Function- TEWL | 22.51 g/m^2/h | Standard Deviation 6.87 |
| Month 6 | Change in Barrier Skin Function- TEWL | 18.08 g/m^2/h | Standard Deviation 2.81 |
Secondary
Change in Exploratory Thickness/Density- High Resolution Ultrasound
high resolution ultrasound will be utilized to assess skin thickness/density.
Time frame: Baseline, 3 Months and 6 Months
Population: 13 pts originally enrolled in the study- 5 subjects withdrew consent.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Epidermal Density | 69.53 μm | Standard Deviation 11.02 |
| Baseline | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Epidermal Thickness | 72 μm | Standard Deviation 7.07 |
| Baseline | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Dermal Thickness | 1257.33 μm | Standard Deviation 351.8 |
| Baseline | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Dermal Density | 10.94 μm | Standard Deviation 4.88 |
| Month 3 | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Dermal Density | 17.18 μm | Standard Deviation 11.54 |
| Month 3 | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Dermal Thickness | 1214.83 μm | Standard Deviation 186.151 |
| Month 3 | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Epidermal Thickness | 82.67 μm | Standard Deviation 15.02 |
| Month 3 | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Epidermal Density | 73.30 μm | Standard Deviation 38.51 |
| Month 6 | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Epidermal Thickness | 73 μm | Standard Deviation 8.9 |
| Month 6 | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Epidermal Density | 79.65 μm | Standard Deviation 19.43 |
| Month 6 | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Dermal Thickness | 1311.33 μm | Standard Deviation 175.08 |
| Month 6 | Change in Exploratory Thickness/Density- High Resolution Ultrasound | Dermal Density | 21.32 μm | Standard Deviation 9.66 |
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. * Ct: threshold cycle * RT-qPCR: Quantitative reverse transcription polymerase chain reaction)
Time frame: Baseline and 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Change in Gene Expression | Collagen 1 | 1.16 fold change | Standard Error 0.28 |
| Baseline | Change in Gene Expression | Collagen 3 | 0.62 fold change | Standard Error 0.42 |
| Baseline | Change in Gene Expression | Elastin | 1.72 fold change | Standard Error 0.63 |
| Baseline | Change in Gene Expression | LOX | 1.06 fold change | Standard Error 0.71 |
| Baseline | Change in Gene Expression | IL8 | 0.24 fold change | Standard Error 0.18 |
| Baseline | Change in Gene Expression | MMP2 | 2.78 fold change | Standard Error 1.98 |
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.
Time frame: Baseline and 6 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Baseline | Change in Histology Assessments | Collagen 3 | 37.82 fold change | Standard Error 7.19 |
| Baseline | Change in Histology Assessments | Collagen 1 | 7.22 fold change | Standard Error 1.63 |
| Baseline | Change in Histology Assessments | Elastin | 32.28 fold change | Standard Error 5.98 |
| Baseline | Change in Histology Assessments | Macrophage | 7.49 fold change | Standard Error 1.73 |