Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI.
BACKGROUND
Recently, the cosmetic market has seen an increase in the options for treatment for people with dark skin.


OBJECTIVE
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.
Marmur
Ellen S
ES
Division of Dermatologic and Cosmetic Surgery, Department of Dermatology, Mount Sinai Medical Center, New York, New York 10029-6574, USA. Ellen.Marmur@MountSinai.org
Taylor
Susan C
SC
Grimes
Pearl E
PE
Boyd
Charles M
CM
Porter
Jennifer P
JP
Yoo
Jane Y
JY
D000328:Adult; D000368:Aged; D001672:Biocompatible Materials / Q000008:administration & dosage / Q000009:adverse effects*; D003357:Cosmetic Techniques; D003879:Dermatologic Agents / Q000008:administration & dosage / Q000009:adverse effects*; D017886:Durapatite / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007627:Keloid / Q000139:chemically induced; D008046:Lip; D008297:Male; D008863:Microspheres; D008875:Middle Aged; D009518:New York; D009666:Nose; D017060:Patient Satisfaction; D011446:Prospective Studies; D012060:Rejuvenation; D018570:Risk Assessment; D015595:Skin Aging / Q000187:drug effects*; D012880:Skin Pigmentation; D016896:Treatment Outcome
D001672:Biocompatible Materials; D003879:Dermatologic Agents; D017886:Durapatite