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

Study Objective: To evaluate the effectiveness and safety of large-gel particle hyaluronic acid with lidocaine (HAL) compared to no treatment for the correction of volume deficits in the dorsal hand.

Design: Prospective, multi-center, randomized, evaluator-blinded, split-hand study

Method: 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 ½-inch thin-walled needles or 25G x 1½-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).

Results: For the first treatment, the mean injection volume was 2.2 mL and in most cases (87.7%) a topical anesthetic was not used. Subjects demonstrated a significantly higher responder rate for HAL (85.3%) compared with no treatment (22.0%) at 12 weeks (P<.0001). Significantly more responders were observed in the treated hand at 16, 20, and 24 weeks. CIPR assessments showed consistently greater improvements in the treated hands compared with the untreated hand from Week 12 to Week 24 (range 74.8% to 89.5%). Most subjects and treating investigators (93.3% to 100%) reported improvements across all timepoints in the GAIS. There was no impairment in hand function after treatment. Fourteen (12.3%) subjects experienced 31 adverse events related to the product and/or injection procedure. Most were mild in severity and none were serious.

Conclusion: Large-gel particle hyaluronic acid with lidocaine, injected with either sharp needle or blunt-tip cannula, is safe, well-tolerated, and superior to no treatment for the correction of volume deficits in the dorsal hand.