BACKGROUND: Nonanimal stabilized hyaluronic acid (NASHA)-based fillers are currently the criterion standard for cosmetic soft tissue augmentation. OBJECTIVE: To report the efficacy, durability, and safety data of a large-particle NASHA filler and a small-particle NASHA filler. METHODS & MATERIALS: A blinded, prospective, randomized subject and evaluator study was conducted at 17 sites in the United States with 248 subjects enrolled. One of the two products was injected into both nasolabial folds and, if deemed necessary, the oral commissures of each subject. A 2-week touch-up injection was provided if necessary. Subjects returned for follow-up visits 2, 6, 12, and 24 weeks after receiving their last injection. Assessments were done using a subject diary, blinded investigator's Wrinkle Severity Rating Score (WSRS), and palpability of product. RESULTS: Both products demonstrated similar efficacy, durability, and safety profiles. CONCLUSION: Although both NASHA fillers demonstrated similar efficacy, durability, and safety, the fanning injection technique, and a faster rate of injection played a key role in the increase in incidence of adverse experiences. Furthermore, the safety of each NASHA product was demonstrated at volumes well beyond the volume range listed on the product inserts.
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