Poly-L-lactic Acid + Microneedling for Smile Lines

Overseen By Joaninha Barbosa, BS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Skincare Physicians of Chestnut Hill

Must not be taking: Blood thinners, Immunosuppressants, others

Disqualifiers: Active smokers, Infections, Keloids, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if using Poly-L-lactic Acid (PLLA, a type of dermal filler) with microneedling effectively treats smile lines around the mouth in adults. It will also assess whether applying PLLA before or after microneedling affects its effectiveness. Participants will receive two treatments a few weeks apart to evaluate improvements in skin texture and appearance. Individuals with mild to moderate wrinkles around their mouth, who do not have certain skin conditions or recent cosmetic treatments, might be suitable for this trial. As a Phase 4 trial, this research focuses on understanding how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires you to stop taking fish oil, aspirin, or other blood thinning agents at least 14 days before treatment. If you are on any immunosuppressive agents, you may not be eligible to participate.

What is the safety track record for Poly-L-lactic Acid and microneedling treatments?

Research has shown that Poly-L-lactic Acid (PLLA) is generally safe for patients. A review found PLLA effective in improving facial appearance, with few negative effects. One study reported a 47% reduction in upper lip wrinkles after several treatments, with little to no serious side effects.

PLLA has been safely used in cosmetic treatments for a long time. It is biocompatible, meaning it works well with the body. When combined with microneedling, a popular and safe skin treatment, PLLA has shown good results in improving skin texture.

Most people using PLLA and microneedling experience only mild side effects, such as temporary redness or swelling. Overall, studies consider the treatment safe. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about using Poly-L-lactic Acid (PLLA) with microneedling for treating smile lines because it offers a unique approach compared to traditional dermal fillers and creams. Unlike conventional treatments that provide immediate but temporary results, PLLA stimulates the body’s natural collagen production, potentially leading to longer-lasting improvements. Additionally, the combination of microneedling with PLLA enhances the absorption and effectiveness of the treatment, making it a promising alternative for those seeking more durable outcomes. Plus, the dual approach—whether applying PLLA first or post-microneedling—offers flexibility in treatment plans, potentially catering to different patient needs and preferences.

What evidence suggests that this trial's treatments could be effective for perioral wrinkles?

This trial will compare two treatment approaches for smile lines using Poly-L-lactic acid (PLLA) and microneedling. Research has shown that PLLA can help reduce wrinkles. In one study, 10 participants noticed improvement in mouth area wrinkles, both at rest and while smiling. Another study found that over 85% of participants were satisfied with their results six months post-treatment. Microneedling has also been proven to enhance skin appearance, with more than 70% of participants seeing improvement 30 days after treatment. In this trial, one group will apply topical PLLA before microneedling, while the other will perform microneedling before applying PLLA. Combining PLLA with microneedling might enhance these effects, leading to smoother skin and fewer wrinkles. ^{3 6 7 8 9}

Who Is on the Research Team?

Jessica G Labadie, MD

Principal Investigator

SkinCare Physicians

Are You a Good Fit for This Trial?

This trial is for adults with mild to moderate smile lines who want to try a new treatment. It involves applying a substance called PLLA on the skin and using microneedling, which are tiny needles that make small punctures in the skin. Participants will get two treatments spaced about a month apart.

Inclusion Criteria

Fitzpatrick Skin Type I-IV

Wrinkle severity graded by the investigator (1-3 on Lemperle scale)

Able to provide written informed consent, understand and be willing to comply with all study related procedures and follow-up visits

Exclusion Criteria

History of keloid formation or hypertrophic scarring

Silicone or synthetic material injections in the areas to be treated

History of sensitivity to analgesic agents, Aquaphor, topical or local anesthetics

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 2 treatments of topical PLLA and microneedling spaced 4-6 weeks apart

8-12 weeks

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

16 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Microneedling
• Poly-L-Lactic Acid

Trial Overview The study tests if putting PLLA on the skin before or after microneedling helps reduce wrinkles around the mouth better. Researchers will look at how well it works by checking skin samples, safety based on any side effects, and improvements in looks and skin texture.

How Is the Trial Designed?

Group I: Arm B Experimental Treatment 2 Interventions

A microneedling treatment is first performed and then topical PLLA is applied.

Group II: Arm A Experimental Treatment 2 Interventions

Topical PLLA applied to perioral region first and then a microneedling treatment performed.

Who Is Running the Clinical Trial?

Skincare Physicians of Chestnut Hill

Lead Sponsor

Trials

1

Recruited

20+

Galderma R&D

Industry Sponsor

Trials

303

Recruited

60,700+

Flemming Ørnskov

Galderma R&D

Chief Executive Officer since 2019

MD, MPH

Baldo Scassellati Sforzolini

Galderma R&D

Chief Medical Officer

MD, PhD

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07225348

Treatment of Perioral Wrinkles Using Topical Poly-L-lactic ... The second goal is to see whether the application of topical PLLA is more effective before or after a microneedling treatment.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11837228/

Poly‐l‐Lactic Acid Is Effective and Safe to Treat the Perioral ... Regarding the WSS, 10 patients experienced wrinkle improvement (at rest and during contraction) (Figure 1). GAIS assessments revealed good to ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.14985

Efficacy and tolerability of a microneedling device for ... Most subjects reported some level of improvement in their appearance at 30 days (73.3%) and 90 days (68.8%) post-treatment. The satisfaction ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12323926/

Advances in Poly-l-lactic Acid Injections for Facial and ... For instance, a study by Fabi et al reported that more than 85% of patients were satisfied with the treatment within 6 months postinjection, ...

5. researchgate.net researchgate.net/journal/Journal-of-Cosmetic-Dermatology-1473-2165/publication/359879876_Efficacy_and_Tolerability_of_a_Microneedling_Device_for_Treating_Wrinkles_on_the_Face/links/6454f22497449a0e1a7d7c84/Efficacy-and-Tolerability-of-a-Microneedling-Device-for-Treating-Wrinkles-on-the-Face.pdf

Efficacy-and-Tolerability-of-a-Microneedling-Device-for- ... The objective of this study was to assess the device's effectiveness for treating wrinkles of the face area. Materials and Methods: Healthy ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11435306/

Efficacy and Safety of Poly-l-Lactic Acid in Facial Aesthetics The primary objective of this systematic review study was to investigate the effectiveness, durability, and adverse events of PLLA treatment for aesthetic ...

7. researchgate.net researchgate.net/publication/330235719_Safety_of_Laser-Assisted_Delivery_of_Topical_Poly-L-Lactic_Acid_in_the_Treatment_of_Upper_Lip_Rhytides_A_Prospective_Rater-Blinded_Study

Safety of Laser-Assisted Delivery of Topical Poly-L-Lactic ... After 3 treatments, the severity of upper lip wrinkles decreased by an average of 47% (p < .05) as calculated by computer-generated image ...

8. ehaclinic.sg ehaclinic.sg/plla/

Poly-L-lactic Acid (PLLA) | EHA Aesthetic Clinic Singapore PLLA is a biocompatible and biodegradable material with a longstanding history of use in aesthetic medicine. It is generally well-tolerated in ...

9. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/20159311/

A Randomized Study of the Efficacy and Safety ... Injectable PLLA provides well-tolerated, effective, and long-lasting (up to 25 months) nasolabial fold wrinkle correction.