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.
*Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland;
†Private Practice, Vista, California;
‡The Center for Dermatology, Cosmetic & Laser Surgery, Mount Kisco, New York;
§Private Practice, Chicago, Illinois;
‖Private Practice and Director of the Clinical Testing Center of Beverly Hills, Beverly Hills, California;
¶SkinCare Physicians, Chestnut Hill, Massachusetts;
#Galderma R&D, Uppsala, Sweden;
**Galderma Laboratories, L.P., Fort Worth, Texas
Address correspondence and reprint requests to: Robert Weiss, MD, Maryland Laser Skin and Vein Institute, 54 Scott Adam Road, Suite 301, Hunt Valley, MD 21030, or e-mail: firstname.lastname@example.org
Supported by Medicis Corporation, a Division of Valeant Pharmaceuticals at the time of study execution.
Investigational sites where R. Weiss, A. Moradi, D. Bank, J. Few, J. Joseph, and J. Dover served as principal investigators received fees to conduct the trial. A. Nogueira and J. Mashburn are employees of Galderma Laboratories, L.P. The other author has indicated no significant interest with commercial supporters.