Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedli… (NCT05085730) | Clinical Trial Compass
CompletedNot Applicable
Assessment Skin Quality and Efficacy of Dermal Line After Four Bipolar Radiofrequency Microneedling Treatments
United States13 participantsStarted 2022-01-14
Plain-language 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.
Who can participate
Age range
21 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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.
Exclusion criteria
. Active localized or systemic infections, that may alter wound healing.
. Immunocompromised subjects.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change of Fine Lines and Wrinkles
Timeframe: Baseline, 3 Months and 6 Months
2
Change of Fine Lines
Timeframe: Baseline, 3 Months and 6 Months
3
Change of Skin Roughness
Timeframe: Baseline, 3 Months and 6 Months
4
Global Aesthetic Improvement Scale (GAIS)
Timeframe: 3 Months and 6 Months
Trial details
NCT IDNCT05085730
SponsorUniversity of Texas Southwestern Medical Center