Abstract
BACKGROUND: Lips are prone to dehydration and aging. Effective noninvasive hyaluronic acid (HA) delivery remains challenging. AIM: To evaluate topical Replenishing Lip Filler-Tiered Release Vesicles (RLF-TRV) in filler-naïve and previously-augmented lips. METHODS: Two single-center trials evaluated efficacy and tolerability of RLF-TRV Serum. Study 1 included filler-naïve subjects or those without lip filler for 12 months. Study 2 enrolled subjects with prior HA lip augmentation (3-9 months earlier) in a double-blind, placebo-controlled design. Participants applied RLF-TRV or placebo twice daily for 3 weeks, followed by a 2-week regression period. Outcomes included grading of shine, texture, and vermilion border, Investigator and Subject Global Aesthetic Improvement Scale (I-GAIS, S-GAIS), and satisfaction. Imaging and tolerability assessments were conducted throughout the study. RESULTS: RLF-TRV significantly improved lip aesthetics (shine, texture, and vermilion border), with high satisfaction across both studies. In Study 1, 94% of treated participants were "Improved" on I-GAIS (p < 0.001), and 81% were "Much-Improved" on S-GAIS (p < 0.05). In Study 2, 88% of treated participants were "Improved" on both I-GAIS and S-GAIS. RLF-TRV was well tolerated, with no recorded adverse events. CONCLUSIONS: RLF-TRV significantly improved lip aesthetics, offering a noninvasive alternative or complementary treatment to injectable procedures.