Abstract
Purpose: To evaluate the effectiveness and safety of a new hyaluronic acid product, HArk, in lip augmentation and correction of upper perioral rhytids. The primary objective was to demonstrate non-inferiority of HArk versus a control (HAjvob) in lip augmentation 8 weeks after last injection (blinded evaluation). Design: In this 48-week, randomized, controlled, evaluator-blinded multicenter study (NCT03320824), treatment with HArk or control (randomized 2:1) was administered on day 1, with optional touch-up offered 4 weeks after initial injection.
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