A Multicenter, Double-Blinded, Randomized, Split-Face Study of the Safety and Efficacy of a Novel Hyaluronic Acid Gel for the Correction of Nasolabial Folds.

BACKGROUND: Injectable hyaluronic acid is frequently used to correct volume loss in nasolabial folds. OBJECTIVE: To compare the safety and efficacy of a novel hyaluronic acid gel to a non-animal stabilized hyaluronic acid (Comparator) gel for the correction of nasolabial folds (NLF). METHODS: Qualified subjects had NLF with a Wrinkle Severity Rating Scale (WSRS) score of 3 or 4 (moderate or severe). NLFs were treated with Test Product on one side of the face and Comparator on the other side of the face (facial side randomly assigned). Improvement from baseline was evaluated at weeks 1, 2, 4, 12, and 24 weeks. The primary study endpoint was the mean change in WSRS score from baseline to week 24. RESULTS: The mean changes in WSRS score from baseline were 1.02 ±0.689 for Test Product and 0.91±0.762 for Comparator. The mean difference in change from baseline in WSRS scoring (Comparator minus Test Product) at week 24 was -0.11 (-0.225-0.001, 95% confidence interval [CI]). The upper boundary (0.001) of the 95% CI was less than the prespecified non-inferiority limit of 0.50, indicating that the Test Product was non-inferior to the Comparator. No subject discontinued the study due to adverse events. CONCLUSION: The Test Product is safe and non-inferior to the Comparator for the correction of nasolabial folds. The Test Product was associated with less swelling, pain, and overall severity of treatment-emergent adverse events than the Comparator.

J Drugs Dermatol. 2018;17(1):66-73.

Animal-based hyaluronic acid fillers: scientific and technical considerations.

BACKGROUND: Successful clinical application of dermal filler products requires an understanding of their physical characteristics and in vivo behavior. This study reviewed the data for hyaluronic acid dermal filler products derived from an animal source--the rooster comb. METHODS: A review of the hyaluronic acid literature was performed. Clinical experience with the animal-derived hyaluronic acid products was evaluated. RESULTS: The source of the hyaluronic acid has not been demonstrated to be a clinically important point of differentiation among filler products. Hypersensitivity reactions are rare and are also present in the products derived from bacteria. Variations that effect the hyaluronic acid products' physical characteristics and clinical performance are more closely related to cross-linking and formulation. Hyaluronic acid gel derived from animal sources is cross-linked by a sulfonyl-bis-ethyl bond and is a soft gel compared with other hyaluronic acid products. There is minimal gel swelling, which results in modest postinjection edema. Optimal clinical application favors patients who desire quick recovery and minimal palpability. CONCLUSIONS: Hyaluronic acid skin filler products derived from an animal source are safe and effective. Successful clinical application should be based on an understanding of the patient's goals and the choice of a hyaluronic acid product with the optimal characteristics.