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METHODS: Subjects (N = 115), aged ≥22 years with a volume deficit in the hand, received treatment on Day 0 with large-gel particle hyaluronic acid with 0.3% lidocaine (HAL) in one hand in a randomized fashion. The fellow untreated hand served as the primary comparator. HAL was applied subcutaneously using either 29G x 1⁄2-inch thin-walled needles or 25G x 11⁄2-inch blunt tip cannulas. Treatments were administered to all subjects at Day 0 and at Month 6, including optional touch-ups 4 weeks after the first injection. The primary effectiveness endpoint was based on ≥1 point of improvement with treatment versus no treatment in the Merz Hand Grading Scale (MHGS) at Week 12. Other assessments included Central Independent Photographic Reviewers (CIPR) evaluations of hand photographs, Global Aesthetic Improvement Scale (GAIS), Subject Satisfaction questionnaires, and safety (including passive and active range of motion).

plastic and reconstructive surgery. global open

Abstract: A Prospective, Multi-Center, Randomized, Evaluator-Blinded, Split-Hand Study to Evaluate the Effectiveness and Safety of Large-Gel Particle Hyaluronic Acid with Lidocaine for the Correction of Volume Deficits in the Dorsal Hand