Robert A Weiss1, Amir Moradi, David Bank, Julius Few, John Joseph, Jeffrey Dover, Xiaoming Lin, Alessandra Nogueira, Jay Mashburn. 1. *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.
Abstract
BACKGROUND: Aging effects, such as facial flatness, increased tissue laxity, and soft tissue descent and deflation, contribute to midface deficiency. OBJECTIVE: To evaluate whether large gel particle hyaluronic acid with lidocaine (LGP-HAL) is more effective in the treatment of midface deficiencies than no treatment. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: The LGP-HAL treatment is well tolerated and provides significant improvement up to 12 months for the correction of midface deficiencies.
RCT Entities:
BACKGROUND: Aging effects, such as facial flatness, increased tissue laxity, and soft tissue descent and deflation, contribute to midface deficiency. OBJECTIVE: To evaluate whether large gel particle hyaluronic acid with lidocaine (LGP-HAL) is more effective in the treatment of midface deficiencies than no treatment. MATERIALS AND METHODS: 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. RESULTS: 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. CONCLUSION: The LGP-HAL treatment is well tolerated and provides significant improvement up to 12 months for the correction of midface deficiencies.
Authors: Amir Moradi; Shawn Allen; David Bank; Ellen Marmur; Steven Fagien; Dee Anna Glaser; Courtney Maguire; Joel L Cohen Journal: Plast Reconstr Surg Date: 2019-10 Impact factor: 4.730
Authors: Hugues Cartier; Per Hedén; Henry Delmar; Per Bergentz; Cecilia Skoglund; Carolina Edwartz; Maria Norberg; Philippe Kestemont Journal: Dermatol Surg Date: 2020-04 Impact factor: 2.914