Treatment of midface deficiencies with Restylane Lyft was effective and well-tolerated with results lasting up to 12 months, according to study results.
Researchers conducted a 15-month trial of 200 patients with mild-to-substantial loss of midface fullness (92% women; mean age, 52.9 years) who were randomly assigned to Restylane Lift (large gel particle hyaluronic acid with lidocaine [LGP-HAL], Galderma Laboratories; n = 150 patients) or no treatment (control; n = 50).
Improvement of at least one grade in the Medicis Midface Volume Scale (MMVS) on each side of the face at 8 weeks, as determined by a blinded evaluator, was used to define treatment success. MMVS score, global aesthetic improvement and patient satisfaction were secondary endpoints.
There were 188 patients (94%) who completed the study. In the LGP-HAL group, LGP-HAL total mean volume injected for initial treatment was 6.23 mL and 3.8 mL at a 12-month retreatment. An optional touch-up injection could be performed at 2 weeks after baseline and 12 months for optional correction. Patients in the control cohort received their first treatment of LGP-HAL at 12 months.
There were 89% of patients in the LGP-HAL cohort who were MMVS responders, with right and left midface combined, compared with 16% of control patients at week 8 (P < .001). MMVS ratings at time points through 12 months for the right and left midface combined and separately, found the LGP-HAL treatment significantly better than no treatment (P < .001).
Most of the patients in the LGP-HAL cohort achieved at least a 1-grade improvement throughout 12 months, with additional treatment at 12 months resulting in increased augmentation.
There were 85% of patients who continued to have a global aesthetic improvement assessed by the treating investigator at 12 months after initial treatment.
Patients in the LGP-HAL cohort reported higher satisfaction beginning with week 4 through 12 months.
There were 49% of patients reporting adverse events at initial treatments and 29% reporting adverse events at second treatment at 12 months, with 80% of the adverse events considered mild in severity.
“LGP-HAL is effective for midface augmentation and correction of midface contour deficiencies and provides clinically meaningful visible aesthetic results for at least 12 months with a very good safety profile,” the researchers concluded. – by Bruce Thiel
Disclosure: The research was supported by Medicis Corp., a division of Valeant Pharmaceuticals at the time of study execution. Weiss reported that the investigational site where he served as principal investigator received fees to conduct the trial. Please see the full study for a list of other researchers’ relevant financial disclosures.