A Multicenter Study of the Safety and Effectiveness of Hyaluronic Acid with a Cohesive Polydensified Matrix for Treatment of Nasolabial Folds in Subjects with Fitzpatrick Skin Types IV, V, and VI

Abstract

Background: Although the use of the hyaluronic acid with cohesive polydensified matrix hyaluronic acid has been well explored in subjects with lighter skin (i.e., Fitzpatrick skin types I, II, and III), further exploration in subjects with Fitzpatrick skin types IV, V, and IV is warranted. The primary purpose of the study was to assess the safety of a cohesive polydensified matrix hyaluronic acid in the correction of nasolabial folds in subjects with Fitzpatrick skin types IV, V and VI, especially assessment of hyperpigmentation, hypopigmentation, and scarring. Effectiveness was also assessed. Methods: A total of 93 subjects were enrolled in this 24-week investigation at three sites in the United States. All were injected bilaterally for nasolabial fold correction with cohesive polydensified matrix hyaluronic acid. Assessments included the recording of adverse events; injected volumes; wrinkle severity ratings; and global aesthetic improvement by evaluating investigators, treating investigators, and study subjects. Results: Injection of cohesive polydensified matrix hyaluronic acid for the treatment of nasolabial folds in subjects with Fitzpatrick skin types IV, V, and VI showed no evidence of an association with hypopigmentation, hyperpigmentation, or scarring. Adverse events reported were typical of dermal filler injections with respect to type, rate, duration, and severity. Conclusion: Cohesive polydensified matrix hyaluronic acid is a safe and well-tolerated dermal filler for subjects with Fitzpatrick skin types IV, V, and VI.