MIAMI BEACH – A large gel particle hyaluronic acid filler with lidocaine (LGP-HAL) was safe and effective for midface augmentation and correction of midface contour deficiencies in a randomized, multicenter, pivotal study.
The product (Perlane, Galderma Laboratories), which is currently approved for moderate to severe facial folds and wrinkles, provided visible, clinically meaningful, aesthetic results for at least 12 months based on assessment by a blinded evaluator, Dr. David E. Bank reported in a poster at the South Beach Symposium.
At 8 weeks after initial treatment, 89% of 150 treated subjects experienced at least a one-point improvement in their combined right and left side Medicis Midface Volume Scale (MMVS) score, compared with 16% of 50 patients who were not treated.
Further, the treated subjects were assessed as having greater midface fullness than the nontreated subjects at every measurement during the first 12 months after treatment, according to Dr. Bank of New York–Presbyterian Hospital/Columbia University Medical Center, New York.
Study participants were men and women aged 18-65 years (mean of 53 years) with MMVS scores of two, three, or four on the validated one- to four-point scale, with one indicating a fairly full midface and four indicating substantial loss of fullness in the midface area. At the initial treatment, the 150 treatment group subjects were injected with a mean volume of 4.21 mL. All but one received subcutaneous injections, and 115 received supraperiosteal injections.
They were evaluated at weeks 2 (when an optional touch-up was allowed) and 4, and months 2, 4, 6, 8, 10, and 12 following the initial treatment.
The treatment group subjects were treated again at 12 months, along with those not treated initially. Another touch-up was allowed at a 2-week assessment, and additional assessments were conducted at weeks 3 and 4.
Treatment was well tolerated. More than 80% of events reported after treatment were mild in severity, and the adverse events that occurred in more than 5% of subjects included implant site hematoma, hemorrhage, pain, swelling, and headache.
One subject had two cases of implant site inflammation that were deemed related by the investigators, and one experienced a serious adverse event (implant site hematoma) deemed related to the procedure as opposed to the device.
No additional risk was seen in those who were treated twice, Dr. Bank noted.
“Facial shape plays an important role in facial attractiveness,” he wrote, adding that full cheeks, in particular, play an important role.
Aging, however, is associated with increased tissue laxity, soft-tissue descent and deflation, and loss of bone, which all contribute to deficiencies in the midface.
Hyaluronic fillers have been used successfully to correct such deficiencies, and the current findings suggest that LGP-HAL also can be used safely to enhance midface aesthetics, he concluded.
This study was funded by Galderma Laboratories.