Effectiveness and Safety of Large Gel Particle Hyaluronic Acid With Lidocaine for Correction of Midface Volume Deficit or Contour Deficiency

Abstract

Aging effects, such as facial flatness, increased tissue laxity, and soft tissue descent and deflation, contribute to midface deficiency. To evaluate whether large gel particle hyaluronic acid with lidocaine (LGP-HAL) is more effective in the treatment of midface deficiencies than no treatment. Subjects with mild to substantial loss of midface fullness were randomized 3:1 to LGP-HAL (Restylane Lyft; Galderma Laboratories, L.P., Fort Worth, TX) or no treatment. Treatment success was defined as at least 1-grade improvement in Medicis Midface Volume Scale (MMVS) on each side of the face at 8 weeks as assessed by a blinded evaluator. Secondary efficacy end points included MMVS score, global aesthetic improvement, and subject satisfaction. Significantly greater percent of subjects achieved treatment success in the LGP-HAL group compared to no treatment at all time points through Month 12 (p < .001). One year after initial treatment, 85% of subjects still had a global aesthetic improvement assessed by the treating investigator. Subject satisfaction demonstrated that LGP-HAL improved the aesthetic appearance of the midface. Most reported adverse events (80%) were mild in severity. The LGP-HAL treatment is well tolerated and provides significant improvement up to 12 months for the correction of midface deficiencies.