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Radiofrequency Microneedling

InMode Morpheus8 System for Aging

N/A
Waitlist Available
Led By Jeffrey Kenkel, MD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Fitzpatrick skin type I-VI.
Presence of facial dermal lines and skin changes of the lower face associated with age or environmental exposure.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months and 6 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of a new device to treat facial and neck skin. The device has been FDA cleared for full body use and this trial will assess its effect on skin quality and dermal lines.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Participants with any skin type can participate in the trial.
Select...
You have wrinkles or skin changes on the lower half of your face due to aging or exposure to the environment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change of Fine Lines
Change of Fine Lines and Wrinkles
Change of Skin Roughness
+1 more
Secondary outcome measures
Adverse Events
Biomechanical Tissue Measurements (Elastic, Viscoelastic and Ultimate Deformation)
Biomechanical Tissue Measurements (Energy Absorption)
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All subjects will receive 4 separate treatments with the InMode Morpheus8 System.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
InMode Morpheus8 System
2022
N/A
~20

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,039 Previous Clinical Trials
1,048,086 Total Patients Enrolled
8 Trials studying Aging
495 Patients Enrolled for Aging
Jeffrey Kenkel, MDPrincipal InvestigatorUT Southwestern- Department of Plastic Surgery
11 Previous Clinical Trials
248 Total Patients Enrolled
1 Trials studying Aging

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I a viable candidate for this research project?

"To qualify for this trial, applicants must be between 21 and 70 years old. Currently there are 12 places available to those that meet the criteria."

Answered by AI

Are there still vacancies to join this investigation?

"Clinicaltrials.gov states that this investigation is no longer accepting participants, after initially being posted on January 14th 2022 and last updated on the 27th of the same month. However, there are 245 other trials actively seeking patients at present."

Answered by AI

What objectives does this research endeavor seek to accomplish?

"The aim of this experiment is to measure the efficacy of a treatment using Clinician's Global Aesthetic Improvement Scale (CGAIS). The duration covers Baseline, 3 Months and 6 Months. Additionally, for secondary outcomes Adverse Events will be monitored at each visit; high resolution ultrasound will assess skin thickness/density; Bio Aquaflux TEWL measurements are used to evaluate epidermal layer barrier function post-treatment."

Answered by AI

Does the age requirement for this research extend beyond 50 years of age?

"As specified by the trial's inclusion criteria, adults aged 21 - 70 are eligible to participate."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
California
Other
Texas
How old are they?
18 - 65
What site did they apply to?
University of Texas Southwestern Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~4 spots leftby Mar 2025