Randomized, Evaluator-Blinded Study Comparing Safety and Effect of Two Hyaluronic Acid Gels for Lips Enhancement.

BACKGROUND: Hyaluronic acid (HA) fillers may differ in terms of gel characteristics and ease of use and it is of interest whether this might affect safety and duration of effect. OBJECTIVE: To compare the long-term safety and effect of 2 HA fillers produced by 2 different technologies for lip enhancement. MATERIALS AND METHODS: Subjects with very thin to moderately thick lips were randomized and treated with HA-RK (N = 31) or HA-JV (N = 29) to improve lip fullness by ≥ 1 grade on a 5-point scale, using a maximum of 3 mL of product. RESULTS: A smaller volume of HA-RK compared with HA-JV was required to improve lip fullness by ≥ 1 grade (mean: 1.54 mL vs 1.94 mL, p < .001). Despite the smaller volume, lip fullness and global aesthetic improvement were comparably sustained in both groups. At 6 months, 60.0% versus 57.7% of subjects (HA-RK vs HA-JV) had improved lip fullness. At 12 months, 71.4% versus 76.0% had aesthetic improvement (blinded evaluations) and 85.7% versus 86.2% felt more attractive. Both products were well tolerated. CONCLUSION: Both products achieved durable improvement in lip fullness and aesthetic appearance. A significantly smaller amount of HA-RK was required compared with HA-JV to achieve optimal treatment effect.

Bio-Dermal Restoration With Rapidly Polymerizing Collagen: A Multicenter Clinical Study.

BACKGROUND: Despite the increasing popularity of facial contouring with hyaluronic acid, innovation has been limited to iterations that feature different particle sizes, concentrations, and degrees of crosslinking. Bio-dermal restoration is a new approach for correcting facial tissue defects by supplementing the natural dermal structure providing a scaffold for fibroblast adherence and proliferation. OBJECTIVES: The purpose of the study was to evaluate the safety of RPC Pure-Collagen for the treatment of facial contours. METHODS: A prospective, multicenter, open-label study in 30 patients treated with RPC Pure-Collagen in the nasolabial fold and followed up to 12 weeks after injection. A subset of patients was further followed up to 9 months after treatment. RPC Pure-Collagen is a sterile, nonpyrogenic, viscous, clear solution composed of pure porcine collagen ethylenediamine tetraacetic acid (EDTA) and Mannitol that can be injected through a 30 gauge needle as a liquid and fibrilizes in situ forming a natural, open 3-dimensional collagen matrix for bio-dermal restoration. RESULTS: No treatment related adverse events were noted in addition to transient injection site reactions typical to injection procedures, which were mild or moderate in severity except for one case of severe bruising. There were no reports of hypersensitivity, supporting that RPC Pure Collagen does not require skin testing prior to treatment. Performance results showed a significant improvement from baseline upon treatment, and at the end of the study, on both the Merz Aesthetic Scale and the Global Aesthetic Improvement Scale assessments. CONCLUSIONS: This initial study shows that RPC Pure-Collagen is safe for its use in facial contouring and provides good indication for long-term safety. Bio-dermal restoration with RPC Pure-Collagen holds promise as safe, lasting, and natural facial contouring treatment.

An Open-Label, Multicenter, Evaluator-Blinded Study to Assess the Efficacy and Safety of a New Hyaluronic Acid-Based Gel Product for Lip Enhancement.

BACKGROUND: A stabilized hyaluronic acid (HA)-based lidocaine-containing gel of nonanimal origin has been developed for lip enhancement. OBJECTIVE: To evaluate the efficacy, safety, and injection procedure of the HA gel in subjects seeking lip enhancement. METHODS: Thirty subjects were treated in the upper and lower lips. Retreatment was offered at 3 months. Efficacy was assessed over 9 months using the Global Aesthetic Improvement Scale (GAIS), the Medicis Lip Fullness Scale, and a subject questionnaire. Safety was assessed by a 14-day subject diary and recording of adverse events (AEs) during the whole study. RESULTS: Over 9 months after treatment, 86% to 97% of subjects and independent evaluators assessed both lips as improved. At all study visits, 72% to 93% of the subjects were satisfied with their lips and ≥96% reported that their lips had a natural look. Most AEs were mild-to-moderate local injection site reactions. CONCLUSION: Lip enhancement with this HA-based gel generated high subject satisfaction and natural-looking lips. The effect lasted for up to 9 months according to the GAIS ratings by subjects and independent evaluators. The product was well tolerated; most AEs were mild-to-moderate local injection site reactions.