Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Assessment of Skin Quality and Efficacy of Dermal Line Improvement Following Four Bipolar Radiofrequency Microneedling Treatments

Conditions
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Aging

Intervention / Treatment
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* Device: InMode Morpheus8 System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female adults between ages 21-70 years of age. Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure. Confirmed BMI ≤ 35. Subjects who can read, understand, and sign the Informed Consent Form. Subjects willing and able to comply with all study requirements. Fitzpatrick skin type I-VI. Minimum of 1 on the Lemperle Wrinkle Assessment Scale, Allergan Fine Line Scale and Allergan Skin Roughness Scale Subject is willing not to undergo any type of aesthetic procedure that could confound the study device treatment effects until he/she completes the study. Exclusion Criteria: Active localized or systemic infections, that may alter wound healing. Immunocompromised subjects. Subjects with coagulation disorder. History of skin photosensitivity disorders, or use of photosensitizing drugs (e.g., tetracycline or sulfa drugs). Pregnant and/or lactating (All female volunteers will be advised about using birth control during the period of study). 5 on the Lemperle Wrinkle Assessment Scale or 4 on the Allergan Fine Line Scale and/or Allergan Skin Roughness Scales Scarring in areas to be treated. Tattoos in the treatment areas to be treated. Significant open facial wounds or lesions. Severe or cystic acne in treatment areas. Current active smoker. Use of Accutane (Isotretinoin) within the past 6 months. Use of topical retinoids within 48 hours. Use of prescription anticoagulants. Pacemaker or internal defibrillator. History of skin disorders resulting in abnormal wound healing (i.e. keloids, extreme dry and fragile skin). Subjects on current oral corticosteroid therapy or within the past 6 months Metal implants in the treatment area. In the opinion of the investigator, subject is unwilling or unable to adhere to all study requirements, including application and follow-up visits. Subjects with a history of radiation therapy to the treatment area. Subject has a history of allergy to lidocaine or ester-based local anesthetics. Subjects with significant cardiac history or rhythm disturbance who may be unable to tolerate lidocaine with epinephrine. Subjects with any skin pathology or condition in the treatment area that could interfere with evaluation or with the use of typical ancillary medical treatments or care used before, during or after treatments (e.g. psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post inflammatory hyperpigmentation). Subjects who are unwilling to shave excessive hair in the treatment area that might influence or impair evaluation in the opinion of the Investigator. Subjects have undergone skin resurfacing or tightening treatments in the treatment area over the past year. Subjects have undergone dermatological treatments such as fillers and neurotoxins for the past 6 months in the treatment area. Subjects have undergone laser and light treatments in the treatment area over the past 3 months. Subjects have undergone superficial peel or microdermabrasion within 4 weeks.

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

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>All subjects will receive 4 separate treatments with the InMode Morpheus8 System. | Device: InMode Morpheus8 System<br>* The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Just perceptible wrinkles Shallow wrinkles Moderately thick wrinkles Deep wrinkles, well defined edges Very deep wrinkles, redundant folds 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 Minimal (1-2 superficial lines) Moderate (3-5 superficial lines) Severe (<5 superficial lines; no crosshatching) Diffuse (diffuse superficial lines; crosshatching) 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) Minimal (slightly course and uneven visual skin texture) Moderate (Moderately coarse and uneven visual skin texture; early elastosis) Severe (severe coarse visual skin texture, crosshatching lines; some elastosis) Diffuse (extreme coarse visual skin texture, deep crosshatched creases; extreme elastosis) Lower value would indicate improvement | Baseline, 3 Months and 6 Months | 
| Global Aesthetic Improvement Scale (GAIS) | Scale will be used to assess aesthetic change Very much improved Much improved Improved No Change Worse Lower value would indicate improvement | 3 Months and 6 Months | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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. Ct: threshold cycle RT-qPCR: Quantitative reverse transcription polymerase chain reaction) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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skin aging, bipolar radiofrequency, microneedling, dermal lines