Poly-L-lactic acid safe, effective for long-term use in treatment of cheek wrinkles
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Key takeaways:
- At 15 months post-treatment, 84.8% of patients achieved improvement in cheek wrinkle severity.
- No new safety signals emerged during the extension trial.
CHICAGO — Patients injected with poly-L-lactic acid maintained improvements in cheek wrinkles up to 21 months after their last treatment sessions, according to results from an extension trial.
Sculptra injectable poly-L-lactic acid (PLLA) was recently approved by the FDA for the correction of cheek wrinkles, Healio reported earlier this year.
Since then, studies have been conducted evaluating the drug’s efficacy in treating cheek wrinkles long-term. One such study was presented in an American Society for Dermatologic Surgery Annual Meeting video abstract.
“The point of the trial was to determine when you inject PLLA along the entire cheek ... can you get improvement in cheek wrinkles?” Sabrina Fabi, MD, volunteer assistant clinical professor at Cosmetic Laser Dermatology in San Diego, said during the video abstract. “This was a 24-month long trial. The initial arm lasted 12 months and the extension lasted an additional 12 months.”
The initial randomized, controlled study assigned patients 2:1 to receive four treatment sessions of PLLA at a maximum dosage of 9 mL using a 25-gauge needle (n = 97; mean age, 60.9 years; 97% women) or placebo (n = 52; mean age, 60.4 years; 96% women), each one month apart.
There were 72 subjects (mean age, 60.8 years; 96% women) enrolled from the main study into the extension arm and evaluated at 19, 21 and 24 months from baseline for improvement in cheek wrinkle severity and aesthetic appearance.
By month 12 in the main study, 71.6% of the PLLA group achieved improvement in cheek wrinkle severity at rest, according to the validated Galderma Cheek Wrinkles Scale response, vs. 26.1% of the placebo group (P < .0001). By month 19 in the extension trial, PLLA-treated subjects experienced an increased rate of 84.8% improvement, which then settled at 76.9% at months 21 and 24.
According to the Global Aesthetic Improvement Scale, aesthetic improvement was seen in 97% of patients at months 19 and 21 and remained high through month 24 at 94%, with many patients achieving improved skin radiance (95%), skin tightness (88%) and jawline contour (86%) at month 24 as well.
PLLA treatment was considered safe and well tolerated. Adverse events, which were mostly mild, occurred in 21% of patients. No new safety signals emerged in the extension arm.
“PLLA is safe and effective for its use when injected along the entire check for the improvement of cheek wrinkles,” Fabi concluded.
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