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

Last updated: October 13, 2023
Sponsor: University of Texas Southwestern Medical Center
Overall Status: Completed

Phase

N/A

Condition

Aging

Treatment

InMode Morpheus8 System

Clinical Study ID

NCT05085730
STU 2021-0916
  • Ages 21-70
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ageor 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 andAllergan Skin Roughness Scale
  8. Subject is willing not to undergo any type of aesthetic procedure that could confoundthe study device treatment effects until he/she completes the study.

Exclusion

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 birthcontrol during the period of study).
  6. 5 on the Lemperle Wrinkle Assessment Scale or 4 on the Allergan Fine Line Scale and/orAllergan 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, extremedry 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 allstudy 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 totolerate lidocaine with epinephrine.
  23. Subjects with any skin pathology or condition in the treatment area that couldinterfere with evaluation or with the use of typical ancillary medical treatments orcare used before, during or after treatments (e.g. psoriasis, rosacea, eczema,seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such aspost inflammatory hyperpigmentation).
  24. Subjects who are unwilling to shave excessive hair in the treatment area that mightinfluence or impair evaluation in the opinion of the Investigator.
  25. Subjects have undergone skin resurfacing or tightening treatments in the treatmentarea over the past year.
  26. Subjects have undergone dermatological treatments such as fillers and neurotoxins forthe 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.

Study Design

Total Participants: 13
Treatment Group(s): 1
Primary Treatment: InMode Morpheus8 System
Phase:
Study Start date:
January 14, 2022
Estimated Completion Date:
December 22, 2022

Study 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.

Connect with a study center

  • University of Texas Southwestern Medical Center

    Dallas, Texas 75390
    United States

    Site Not Available

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