Gary Monheit1, Joely Kaufman-Janette2, John H Joseph3, Ava Shamban4, Jeffrey S Dover5, Stacy Smith6. 1. Private Practice, Total Skin and Beauty Dermatology Center, Birmingham, Alabama. 2. Private Practice, Skin Research Institute, Miami, Florida. 3. Private Practice, Clinical Testing of Beverly Hills, Beverly Hills, California. 4. Private Practice, AVA MD, Santa Monica, California. 5. Private Practice, Skin Care Physicians, Chestnut Hill, Massachusetts. 6. Private Practice, California Dermatology & Clinical Research Institute, Encinitas, California.
Abstract
BACKGROUND: A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA) chains with reduced cross-linking was developed for aesthetic procedures. OBJECTIVE: The efficacy, durability, and safety of 2 of these resilient HA (RHA) fillers, and their noninferiority to an effective HA comparator available in the United States, were tested in the treatment of dynamic facial wrinkles. METHODS: A 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial was carried out on 174 subjects presenting moderate-to-severe bilateral nasolabial folds (NLFs). Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators. Self-perception was evaluated with FACE-Q and satisfaction scales. RESULTS: The per-protocol populations included 67 and 62 subjects of all Fitzpatrick skin-phototypes, in the 2 comparison groups. Significant improvement of mean WSRS scores and associated responder rates established the noninferiority of RHA fillers to their comparator, over 15 months. Aesthetic improvement and subject satisfaction were durably high, with no meaningful differences between the fillers. Treatments were safe and well tolerated. CONCLUSION: The 2 RHA fillers are at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin-phototypes.
RCT Entities:
BACKGROUND: A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA) chains with reduced cross-linking was developed for aesthetic procedures. OBJECTIVE: The efficacy, durability, and safety of 2 of these resilient HA (RHA) fillers, and their noninferiority to an effective HA comparator available in the United States, were tested in the treatment of dynamic facial wrinkles. METHODS: A 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial was carried out on 174 subjects presenting moderate-to-severe bilateral nasolabial folds (NLFs). Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators. Self-perception was evaluated with FACE-Q and satisfaction scales. RESULTS: The per-protocol populations included 67 and 62 subjects of all Fitzpatrick skin-phototypes, in the 2 comparison groups. Significant improvement of mean WSRS scores and associated responder rates established the noninferiority of RHA fillers to their comparator, over 15 months. Aesthetic improvement and subject satisfaction were durably high, with no meaningful differences between the fillers. Treatments were safe and well tolerated. CONCLUSION: The 2 RHA fillers are at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin-phototypes.
Authors: Maarten J Ottenhof; Inge J Veldhuizen; Lusanne J V Hensbergen; Louise L Blankensteijn; Wichor Bramer; Berend Vd Lei; Maarten M Hoogbergen; René R W J Hulst; Chris J Sidey-Gibbons Journal: Aesthetic Plast Surg Date: 2022-06-28 Impact factor: 2.326
Authors: Hema Sundaram; Ava Shamban; Joel Schlessinger; Joely Kaufman-Janette; John H Joseph; Mark Lupin; Zoe Draelos; Wayne Carey; Stacy Smith; Laura Eaton Journal: Dermatol Surg Date: 2022-01-01 Impact factor: 3.398
Authors: Carola de la Guardia; Ada Virno; Maria Musumeci; Aude Bernardin; Michael B Silberberg Journal: Facial Plast Surg Date: 2022-02-03 Impact factor: 1.286