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A Randomized, Evaluator-Blinded, Multi-Center Study to Evaluate Safety and Effectiveness of a Biostimulatory Poly-L-Lactic Acid Injectable Implant after Changes in Reconstitution

Younghoon Cho, MD, PhD, Integrated Aesthetics, Spring, TX, Melanie Palm, MD, Art of Skin MD, Solana Beach, CA, Susan Weinkle, MD, Susan H Weinkle MD, Bradenton, FL, Brenda LaTowsky, MD, Investigate MD, Scottsdale, AZ and Heidi Prather, MD, Westlake Dermatology Clinical Research Center, Austin, TX
Goals/Purpose

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To evaluate safety and effectiveness of a biostimulatory poly-L-lactic acid (PLLA) injectable implant for correction of nasolabial folds after changes in reconstitution and injection procedures compared to US label.

Methods/Technique

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In this 48-week, randomized, evaluator-blinded, multi-center study (NCT03780244), subjects were treated to optimal correction of nasolabial folds at a single treatment regimen consisting of 4 injection sessions with 4-week intervals, with PLLA reconstituted with 8 mL or 5 mL sterile water for injection. The 8 mL product included an additional 1 mL 2%-lidocaine, and was injected immediately after reconstitution without standing time. Primary endpoint for effectiveness was blinded evaluation of change from baseline of both nasolabial folds at Week 48 using a validated wrinkle assessment scale (WAS)1. Aesthetic improvement and adverse events were assessed.

Results/Complications

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A total of 59 subjects were included in the 8 mL group and 21 subjects in the 5 mL group. Most subjects were female (95%), mean age was 51.5 years. Both groups demonstrated high WAS responder rates (at least 1-grade improvement from baseline) at Week 24 (≥75%) and Week 48 (≥67%; hence primary effectiveness endpoint metAesthetic improvement was high (≥86%) throughout the study. Adverse events related to study product or injection procedure were reported by 33% of subjects in the 5 mL group and by 12% in the 8 mL group, most events being mild and transient.

Conclusion

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PLLA was effective for treatment of nasolabial folds, and safety was not compromised using a higher reconstitution volume including lidocaine, administered immediately after reconstitution.

References

  1. Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A Classification of Facial Wrinkles. Plast Reconstr Surg. 2001;108(6):1735-50.
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