Safety and effectiveness of hyaluronic acid fillers in skin of color.

OBJECTIVES: To assess the safety and effectiveness of hyaluronic acid (HA) fillers in skin of color.

METHODS: Two prospective studies followed up subjects with Fitzpatrick skin phototypes of IV, V, or VI for 24 weeks after dermal filler injections. In a double-blind, randomized study, subjects were injected with one of three high concentration (24 mg/mL) HA fillers (Juvéderm Ultra, Ultra Plus, and 30) in one nasolabial fold and Zyplast collagen in the other. In an open-label, randomized study, subjects received one of three low concentration (5.5 mg/mL) HA fillers (Hylaform, Hylaform Plus, and Captique) in both nasolabial folds.

RESULTS: A total of 160 subjects (a subset of 439 study subjects) were randomized and treated with one of the three high concentration fillers, and 119 subjects were randomized and treated with one of the three low concentration fillers. For subjects treated with the high concentration fillers there were no occurrences of hypersensitivity or hypertrophic scarring, and no increased incidence of hyperpigmentation or hypopigmentation in non-Caucasian vs. Caucasian subjects. For subjects treated with the low concentration fillers there were no occurrences of keloid formation, hypertrophic scarring, hypopigmentation, hypersensitivity, and three instances of mild hyperpigmentation. For all of the fillers the majority of subjects maintained >/=1 point improvement in nasolabial fold severity scores through 24 weeks.

CONCLUSIONS: All of the HA fillers were well tolerated in individuals with skin of color and demonstrated effectiveness throughout the 24 week period. Furthermore, the fillers provided smooth, natural-looking wrinkle correction in darker skin types.