Study: Injectable Poly-L-lactic Acid Treatments Effective for Cheek Wrinkles

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Sculptra poly-L-lactic acid injectable implant treatments (PLLA-SCA) are effective in reducing the severity of cheek wrinkles, according to a recent study.¹ Sculptra works by gradually stimulating collagen formation, according to Galderma, the company that developed the product.

A plant-derived alpha-hydroxy polymer, Sculptra received US Food and Drug Administration clearance in April 2023.² It is intended for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles, according to Galderma.

The study, which was published in the January issue of the Journal of Drugs in Dermatology, included male and female immune-competent adults with moderate to severe cheek wrinkles at rest, as measured by the Galderma Cheek Wrinkle Scale (GCWS).

Study method

The subjects were randomized to receive PLLA-SCA injections (150 mg; 8 mL reconstitution in sterile water for injection) + 1 mL lidocaine hydrochloride (2%), or no treatment (control), according to the study.

149 subjects were included: 97 in the PLLA-SCA group and 52 in the control group. Most subjects were female (96.6%), White (90.6%), and not of Hispanic/Latino origin (91.9%). Mean age was 60.7, with 77.9% of the subjects older than 55.

Up to 3 additional treatments were performed at monthly intervals, and follow-up occurred at months 7, 9, and 12. The primary endpoint was improvement of 1 grade or more in GCWS at rest for both cheeks at month 12, based on a blinded evaluator assessment.

Treating investigators assessed the combined improvement on both sides of the face using the 7-point Global Aesthetic Improvement Scale ([GAIS]: very much improved, much improved, improved, no change, worse, much worse, or very much worse) at all visits for the PLLA-SCA group and at months 7, 9, and 12 for the control group.

Results were also measured using a subject satisfaction questionnaire.

Results

The researchers found the treatments to be well-tolerated. No serious treatment-related adverse events were reported. The most common were injection site bruising (11.3%), dizziness (2.1%), and headache (2.1%), all of which resolved within 1-13 days. Time before return to social activity ranged between 3.9 hours (after treatment 1) and 7.1 hours (after treatment 4), the study authors wrote.

Treating investigators agreed or strongly agreed that skin radiance was improved in more than 95% of subjects. Also, skin appeared tighter (>88%) and jawline contour was improved (>85%).

From month 7 through month 12, subject satisfaction questionnaires revealed that most PLLA-SCA recipients reported treatment results to be excellent, very good, good, or satisfactory regarding improvement in skin radiance (≥90%), sagging (≥84%), and firmness (≥91%).

Most PLLA-SCA subjects said their skin looked younger (≥90%) and more refreshed (≥91%), according to the study. The majority reported improved overall satisfaction with their appearance (≥92%), “natural-looking” results (≥ 86%), and a desire to have the same PLLA-SCA treatment again (≥84%).

Most also indicated they would recommend the treatment to a friend and that they felt better about themselves (≥92%) and more confident (≥90%).

References

1. Fabi S, Hamilton T, LaTowsky B, et al. Effectiveness and safety of Sculptra poly-l-lactic acid injectable implant in the correction of cheek wrinkles. J Drugs Dermatol. 2024;23(1).1297-1305.https://jddonline.com/articles/effectiveness-and-safety-of-sculptra-poly-l-lactic-acid-injectable-implant-in-the-correction-of-cheek-wrinkles-S1545961624P1297X/?_page=9
2. Buchanan L. FDA gives the green light for cheek wrinkle solution. Dermatology Times. https://www.dermatologytimes.com/view/fda-gives-the-green-light-for-cheek-wrinkle-solution. Accessed January 22, 2024.