Safety of nonanimal stabilized hyaluronic acid dermal fillers in patients with skin of color: a randomized, evaluator-blinded comparative trial.
BACKGROUND
Nonanimal stabilized hyaluronic acid (NASHA) dermal fillers have been used in the United States since 2003 for the treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds. Previous trials with NASHA dermal fillers have included small numbers of patients with pigmented skin.


OBJECTIVE
This randomized, evaluator-blinded, split-face trial compared the safety and efficacy of two variable-particle NASHA fillers in the correction of nasolabial folds in patients with Fitzpatrick skin types IV, V, and VI.


METHODS
One hundred fifty patients (predominantly African American) were enrolled at 10 sites. Patients received one treatment (with an optional touch-up treatment at week 2) with small- and large-particle NASHA gel randomized to the left or right side of the face. Safety was evaluated through patient diaries for the first 2 weeks and physician assessments at 3 days and 2, 6, 12, and 24 weeks after treatment for adverse events (AEs), skin pigmentation changes, and keloid formation.


RESULTS
All related AEs were mild or moderate and of limited duration. They included bruising, tenderness, edema, redness, itching, pain, and changes in pigmentation. The incidence of AEs was not different between the 2 preparations, and no patient developed a keloid. There were 3 reported mass formations, 2 of which were infectious in nature.


CONCLUSIONS
In patients with skin of color, NASHA dermal fillers are safe for the correction of moderate to severe facial folds and wrinkles, with no immunogenicity or keloid formation and only mild to moderate AEs occurring around the injection site.
Taylor
Susan C
SC
Society Hill Dermatology, Philadelphia, Pennsylvania 19107, USA. taylorderm@aol.com
Burgess
Cheryl M
CM
Callender
Valerie D
VD
D000293:Adolescent; D000328:Adult; D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage / Q000009:adverse effects*; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D004890:Erythema / Q000139:chemically induced; D005145:Face; D005260:Female; D006801:Humans; D006820:Hyaluronic Acid / Q000008:administration & dosage / Q000009:adverse effects*; D017495:Hyperpigmentation / Q000139:chemically induced*; D007271:Injections, Intradermal / Q000379:methods*; D008297:Male; D008875:Middle Aged; D015143:Philadelphia; D011446:Prospective Studies; D016037:Single-Blind Method; D015595:Skin Aging / Q000187:drug effects*; D016896:Treatment Outcome
D001672:Biocompatible Materials; D003879:Dermatologic Agents; D006820:Hyaluronic Acid