Final Report on the Safety and Efficacy of Poly-L-Lactic Acid Filler (Gana V) Injection for the Correction of Nasolabial Fold: A Double-Blind, Non-Inferiority, Randomized, Split-Face Controlled Trial.

backgroundWe presented the interim results (6 months) of the trial on the safety and efficacy of poly-L-lactic acid filler (PLLA; Gana V) injection for the correction of nasolabial fold (NLF); however, no long-term follow-up trials through 24 months have been conducted on this topic.

objectiveWe aimed to evaluate the safety and efficacy of Gana V, a new PLLA filler, over 24 months for NLF correction compared with Sculptra, a well-established PLLA filler.

methodsThis double-blind, randomized, non-inferiority, and split-face controlled trial was conducted in France. After the injection of both Gana V and Sculptra on each side of the participants' NLFs, blinded investigators assessed the Wrinkle Severity Rating Scale (WSRS) grade as the primary outcome at each subsequent visit, up to 24 months. The final report on this trial was registered with ClinicalTrials.gov (number NCT05215054).

resultsA total of 55 participants with moderate-to-severe NLFs, aged 34 to 70 years (mean age: 53.8 [8.7] years; 87.3% female), were enrolled in the trial. After 24 months, Gana V significantly improved the mean WSRS score (adjusted mean difference [aMD], -0.21; 95% CI, -0.41 to -0.02) in the intention-to-treat analysis, while Sculptra did not show significant improvement (aMD -0.12; 95% CI, -0.28 to 0.05). The outcomes aligned with the 6-month results reported in previous study (aMD, -0.25; 95% CI, -0.49 to -0.01), which supported the sustained efficacy of Gana V over an extended follow-up period. Non-inferiority of Gana V was established as the adjusted mean difference in change between the two treatment groups ranged from -0.25 to 0.10, with the upper bound below the predefined non-inferiority margin of 0.5 (non-inferiority p<0.001). Both treatment groups exhibited similar adverse reaction profiles. Similar results were observed in the per-protocol analysis.

conclusionsThrough the final report of the trial, Gana V was non-inferior to Sculptra with respect to the NLF correction and safety profile. Gana V demonstrated its long-term efficacy through 24 months. LEVEL OF EVIDENCE I: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .