Clinical trial NCT05085730: Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments
Official title: Clinical Assessment of Skin Quality and Efficacy of Dermal Line Improvement Following Four Bipolar Radiofrequency Microneedling Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: skin aging
bipolar radiofrequency
microneedling
dermal lines
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 13
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Change of Fine Lines and Wrinkles
timeFrame: Baseline, 3 Months and 6 Months
measure: Change of Fine Lines
timeFrame: Baseline, 3 Months and 6 Months
measure: Change of Skin Roughness
timeFrame: Baseline, 3 Months and 6 Months
measure: Global Aesthetic Improvement Scale (GAIS)
timeFrame: 3 Months and 6 Months
Secondary outcomes:
measure: Adverse Events
timeFrame: Baseline, Day 30, Day 60, Day 90, Month 3 and Month 6
measure: Change in Exploratory Thickness/Density- High Resolution Ultrasound
timeFrame: Baseline, 3 Months and 6 Months
measure: Change in Barrier Skin Function- TEWL
timeFrame: Baseline, 3 Months and 6 Months
measure: Biomechanical Tissue Measurements (Laxity, Elasticity)
timeFrame: Baseline, 3 Months and 6 Months
measure: Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
timeFrame: Baseline, 3 Months and 6 Months
measure: Biomechanical Tissue Measurements (Stiffness)
timeFrame: Baseline, 3 Months and 6 Months
measure: Biomechanical Tissue Measurements (Energy Absorption)
timeFrame: Baseline, 3 Months and 6 Months
measure: Change in Gene Expression
timeFrame: Baseline and 6 Months
measure: Change in Histology Assessments
timeFrame: Baseline and 6 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
Study officials:
affiliation: UT Southwestern- Department of Plastic Surgery
name: Jeffrey Kenkel, MD
role: PRINCIPAL_INVESTIGATOR
References: