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

• ClinicalTrials.gov Identifier: NCT05085730
• Recruitment Status: Active, not recruiting
• First Posted: October 20, 2021
• Last Update Posted: January 25, 2023
• Sponsor: University of Texas Southwestern Medical Center
• Information provided by (Responsible Party): Jeffrey M. Kenkel, University of Texas Southwestern Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Aging	Device: InMode Morpheus8 System	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 12 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Assessment of Skin Quality and Efficacy of Dermal Line Improvement Following Four Bipolar Radiofrequency Microneedling Treatments
• Actual Study Start Date: January 14, 2022
• Actual Primary Completion Date: December 13, 2022
• Estimated Study Completion Date: June 30, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment; All subjects will receive 4 separate treatments with the InMode Morpheus8 System.	Device: InMode Morpheus8 System; The InMode Morpheus8 System is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis and neoelastogenesis.

Outcome Measures

Primary Outcome Measures :

1. Change of fine lines and wrinkles [ Time Frame: 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.

2. Change of fine lines [ Time Frame: 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

3. Change of skin roughness [ Time Frame: 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

4. Clinician's Global Aesthetic Improvement Scale (CGAIS) [ Time Frame: 3 Months and 6 Months ]
   Scale will be used to assess aesthetic change

Secondary Outcome Measures :

1. Adverse Events [ Time Frame: Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6 ]
   Adverse events will be monitored at each visit
2. Subject Global Aesthetic Improvement Scale (SGAIS) [ Time Frame: 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

3. Patient Satisfaction Questionnaire [ Time Frame: 3 Months and 6 Months ]

   Patients will be asked to complete a subjective assessment comprising of 3 questions-

   1. improvement on fine lines and wrinkles
   2. satisfaction with the treatment
   3. treatment recommendation
4. Change in exploratory skin measurements- high resolution ultrasound [ Time Frame: Baseline, 3 Months and 6 Months ]
   high resolution ultrasound will be utilized to assess skin thickness/density.
5. Change in exploratory skin measurements- OCT [ Time Frame: Baseline, 3 Months and 6 Months ]
   OCT will be used to gather topographical and histologic images of treated skin.
6. Change in exploratory skin measurements- TEWL [ Time Frame: Baseline, 3 Months and 6 Months ]
   TEWL measurements (Bio Aquaflux) will be used to evaluate barrier function of the skin epidermal layer to determine healing after treatment.
7. Change in exploratory skin measurements- BTC [ Time Frame: Baseline, 3 Months and 6 Months ]
   BCT 2000 to assess skin thickness, density, firmness as well as the integrity of the stratum corneum
8. Change in micro-biopsy collection- Gene Expression [ Time Frame: Baseline, 3 Month and 6 Months ]
   Gene expression assessments will be completed tp analyze protein related to collagen, elastin, and the extracellular matrix production.
9. Change in micro-biopsy collection- Histology [ Time Frame: Baseline, 3 Month and 6 Months ]
   Histological assessments will be completed to correlate changes to the skin after treatments.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Sponsors and Collaborators

University of Texas Southwestern Medical Center

Investigators

• Principal Investigator: Jeffrey Kenkel, MD; UT Southwestern- Department of Plastic Surgery

More Information

• Responsible Party: Jeffrey M. Kenkel, Principle Investigator, University of Texas Southwestern Medical Center
• ClinicalTrials.gov Identifier: NCT05085730
• Other Study ID Numbers: STU 2021-0916
• First Posted: October 20, 2021
• Last Update Posted: January 25, 2023
• Last Verified: January 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jeffrey M. Kenkel, University of Texas Southwestern Medical Center:

skin aging; bipolar radiofrequency; microneedling; dermal lines