Microneedling RF + PLLA for Facial Rejuvenation

Overseen By Robert C Tung

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must not be taking: HIV medications, GLP-1 agonists

Disqualifiers: Facial surgeries, Pregnant, HIV+, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests microneedling with radiofrequency to determine if it improves facial appearance by altering fat thickness in areas like the temples, cheeks, and under the chin. Some participants will also use a topical treatment called PLLA, a type of dermal filler, to assess its impact on the results. The trial will measure participants' satisfaction with the treatment and their perceived outcomes. Those interested in this trial should have cosmetic concerns about their face and should not have had recent facial treatments or surgery. As an unphased trial, this study offers an opportunity to explore innovative cosmetic treatments and contribute to advancing aesthetic medicine.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using glucagon-like peptide-1 receptor agonists (like Ozempic or semaglutide) during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that microneedling with radiofrequency (RF) is generally safe and well-tolerated for various skin issues, especially when performed by trained professionals. However, serious risks include burns, scarring, fat loss, and nerve damage. Proper training and equipment are crucial to prevent these problems.

Using microneedling RF with poly-L-lactic acid (PLLA) can firm the skin without causing fat loss. This combination effectively tightens loose or sagging skin.

Overall, despite potential risks, microneedling RF and its combination with PLLA are generally safe when performed correctly. Treatments should be conducted by qualified professionals using approved devices to minimize the risk of complications. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about microneedling radiofrequency (RF) with topical poly-L-lactic acid (PLLA) for facial rejuvenation because it combines advanced technology with a powerful rejuvenating agent. Unlike traditional treatments like topical creams or surgical facelifts, microneedling RF delivers energy below the skin's surface to stimulate collagen production more effectively. The addition of PLLA, a biocompatible substance, further enhances skin volume and smoothness. This combination promises to rejuvenate skin with minimal downtime, offering a less invasive yet potent alternative to existing options.

What evidence suggests that this trial's treatments could be effective for facial rejuvenation?

Studies have shown that microneedling with radiofrequency (RF), one of the treatments in this trial, can noticeably improve skin appearance and texture, with benefits lasting for months. Research indicates that this technique tightens and refreshes the skin by boosting collagen production. In this trial, some participants will receive microneedling RF combined with a cream called poly-L-lactic acid (PLLA), another treatment arm. This combination is believed to enhance the treatment's effectiveness in firming loose skin and increasing skin thickness without causing fat loss. Early findings suggest that using both treatments together might be more effective for facial rejuvenation than microneedling RF alone. This new method likely works by creating tiny channels in the skin, allowing PLLA to penetrate and initiate a healing process. ^{1 4 6 7 8}

Who Is on the Research Team?

Ying Chen, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for individuals seeking facial rejuvenation who can consent and follow the study plan. It's not for those with keloid scars, PLLA allergies, current aesthetic treatment trials, HIV+, pregnant/breastfeeding women, recent facial treatments/surgeries, skin infections/lesions in the area or using certain diabetes drugs.

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

History of keloids or abnormal scarring

Known allergy to poly-L-lactic acid (PLLA)

Current participation in another clinical trial involving facial aesthetic treatments

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive microneedling RF treatment with or without topical PLLA

6 months

Follow-up

Participants are monitored for changes in satisfaction and perceived outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Microneedling Radiofrequency
• PLLA

Trial Overview The study tests if microneedling RF affects fat thickness in face areas and if adding topical PLLA changes this outcome. Participants will receive microneedling with either PLLA or sterile water (control) to compare effects on skin texture and satisfaction.

How Is the Trial Designed?

Group I: microneedling radiofrequency (RF) Experimental Treatment 1 Intervention

Group II: microneedling RF treatment with topical poly-L-lactic acid (PLLA) Experimental Treatment 2 Interventions

Group III: microneedling RF treatment with placebo Experimental Treatment 2 Interventions

Group IV: no treatment Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38051121/

Microneedling Radiofrequency Enhances Poly-L-Lactic ... PLLA can be delivered through microchannels produced by MFR. PLLA enhances the efficacy of MFR for skin laxity without lipolysis.

2. academic.oup.com academic.oup.com/asj/article/45/10/1065/8171359

Poly-L-Lactic Acid in Aesthetic Dermatology: A Decade ... Findings confirm that PLLA induces a regenerative cascade marked by M2 macrophage polarization, transforming growth factor beta 1–mediated fibroblast activation ...

3. researchgate.net researchgate.net/publication/376236599_Microneedling_radiofrequency_enhances_poly-L-lactic_acid_penetration_that_effectively_improves_facial_skin_laxity_without_lipolysis

Microneedling Radiofrequency Enhances Poly-L-Lactic ... The study reported significant improvements in skin laxity, with increases in dermal thickness observed. This combination appears to be ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07261527?term=NA

Characterization of Skin and Facial Fat Pad Thickness ... The purpose of this study is to evaluate whether microneedling RF subcutaneous fat pad thickness in the temple, submental, and cheek regions, to ...

5. anndermatol.org anndermatol.org/Synapse/Data/PDFData/0140AD/ad-37-e9.pdf

Real-World Clinical Practice on Skin Rejuvenation Among ... In this group, 30.8% of respondents reported using a lower energy level and fewer lines. (around 300–350 shots) of HIFU compared to the higher ...

6. drodaniel.com drodaniel.com/rf-microneedling-what-you-need-to-know-about-safety-genius-rf-vs-morpheus8-and-choosing-the-right-treatment/

RF Microneedling: What You Need to Know About Safety ... The key takeaway isn't that RF microneedling is unsafe—it's that this technology requires proper training, evidence-based device selection, and ...

7. clderm.com clderm.com/rf-microneedling-and-the-fda-what-you-need-to-know-about-safety-and-proven-results/

RF Microneedling and the FDA: What You Need to Know ... When performed by board-certified dermatologists using FDA-cleared technology, RF microneedling is both safe and scientifically proven to ...

8. researchgate.net researchgate.net/publication/348945691_Safety_of_combining_cosmetic_injectables_with_radiofrequency_microneedling_A_45-year_review

Safety of combining cosmetic injectables with ... Theoretical risks of combining energy‐based treatment with neuromodulator injections include unintentional spread, which may result in eyelid ptosis and ...