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

NCT05085730 | Completed Results FDA Device

• 1 other identifier: STU 2021-0916
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging

Keywords

skin aging; bipolar radiofrequency; microneedling; dermal lines

Outcome Measures

Primary Outcomes (4)

• 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.

  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 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

  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) 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

  Baseline, 3 Months and 6 Months

• 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

  3 Months and 6 Months

Secondary Outcomes (9)

• Adverse Events

  Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6

• Change in Exploratory Thickness/Density- High Resolution Ultrasound

  Baseline, 3 Months and 6 Months

• Change in Barrier Skin Function- TEWL

  Baseline, 3 Months and 6 Months

• Biomechanical Tissue Measurements (Laxity, Elasticity)

  Baseline, 3 Months and 6 Months

• Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)

  Baseline, 3 Months and 6 Months

Study Arms (1)

Treatment

EXPERIMENTAL

All subjects will receive 4 separate treatments with the InMode Morpheus8 System.

Device: InMode Morpheus8 System

Interventions

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.

Treatment

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Results Point of Contact

• Title: Research Coordinator
• Organization: UT Southwestern

jennifer.barillas@utsouthwestern.edu

214-645-8907

Study Officials

• Jeffrey Kenkel, MD

  UT Southwestern- Department of Plastic Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: September 27, 2021
• First Posted: October 20, 2021
• Study Start: January 14, 2022
• Primary Completion: December 22, 2022
• Study Completion: December 22, 2022
• Last Updated: October 31, 2023
• Results First Posted: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)