Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofreque… (NCT07261527) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Characterization of Skin and Facial Fat Pad Thickness Changes Following Microneedling Radiofrequency With and Without Topical Poly-L-Lactic Acid for Facial Rejuvenation
United States30 participantsStarted 2025-11-24
Plain-language summary
The purpose of this study is to evaluate whether microneedling RF subcutaneous fat pad thickness in the temple, submental, and cheek regions, to determine whether the addition of topical PLLA after microneedling RF alters or preserves subcutaneous fat pad thickness and to assess patient satisfaction and perceived outcomes following microneedling RF ± PLLA treatment.
Who can participate
Age range
18 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:
* Seeking facial rejuvenation for cosmetic concerns
* Able and willing to provide informed consent
* Willing to comply with study procedures and follow-up visits
Exclusion Criteria:
* Prior filler injection or energy-based device treatment to the face within the past 6 months
* Previous facial surgeries
* Pregnant or breastfeeding
* Active infection, dermatitis, or open lesions in the treatment area
* History of keloids or abnormal scarring
* Known allergy to poly-L-lactic acid (PLLA)- Current participation in another clinical trial involving facial aesthetic treatments
* Presence of pre-cancerous or cancerous lesions in the treatment area
* Current or planned use of glucagon-like peptide-1 receptor agonists (e.g., Ozempic, semaglutide) during the study period. Subjects on these medications will be excluded due to potential effects on facial fat and overall weight.
* HIV+ patients
* Patients on HIV medications- Patients that have eczema and rosacea
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 in subcutaneous fat pad thickness as measured by high-frequency ultrasound imaging
Timeframe: Baseline, 6 months
Trial details
NCT IDNCT07261527
SponsorThe University of Texas Health Science Center, Houston