Six-Month Safety Results of Calcium Hydroxylapatite for Treatment of Nasolabial Folds in Fitzpatrick Skin Types IV to VI.

Dermatol Surg. 2009 Aug 25; Marmur ES, Taylor SC, Grimes PE, Boyd CM, Porter JP, Yoo JYBACKGROUND Recently, the cosmetic market has seen an increase in the options for treatment for people with dark skin. OBJECTIVES This study evaluates the use of calcium hydroxylapatite (CaHA), a dermal filler indicated for the correction of moderate to severe facial wrinkles and folds, including the nasolabial folds (NLFs) in individuals with dark skin. METHODS This open-label, nonrandomized, prospective, five-center trial enrolled 100 patients aged 18 and older with Fitzpatrick skin types IV to VI. CaHA was injected subdermally with a 25- to 27-gauge needle. Participants received a range of 0.6 to 2.8 mL of CaHA and returned at 3 and 6 months to be assessed for keloid formation, hypertrophic scarring, and hyper- or hypopigmentation. If necessary, each subject was offered a touch-up at the conclusion of the 6-month visit. RESULTS No reports of keloid formation, hypertrophic scarring, hypo- or hyperpigmentation, or other clinically significant adverse events were recorded. CONCLUSIONS People with dark skin injected subdermally with CaHA do not show signs of keloid formation, hypertrophic scarring, or hyper- or hypopigmentation. Because of this safety feature, as well as other characteristics of the product already shown in clinical literature, CaHA is an attractive dermal filler in this population. BioForm Medical, Inc. provided the products and equipment for this study. Drs. Marmur and Boyd are members of the Medical Education Faculty of Bioform.