title: Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI.
abstract: 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.
authors.affiliation: Division of Dermatologic and Cosmetic Surgery, Department of Dermatology, Mount Sinai Medical Center, New York, New York 10029-6574, USA. Ellen.Marmur@MountSinai.org
authors.forename: Ellen S
authors.initials: ES
authors.lastname: Marmur
authors.forename: Susan C
authors.initials: SC
authors.lastname: Taylor
authors.forename: Pearl E
authors.initials: PE
authors.lastname: Grimes
authors.forename: Charles M
authors.initials: CM
authors.lastname: Boyd
authors.forename: Jennifer P
authors.initials: JP
authors.lastname: Porter
authors.forename: Jane Y
authors.initials: JY
authors.lastname: Yoo
mesh_terms: 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
chemical_list: D001672:Biocompatible Materials; D003879:Dermatologic Agents; D017886:Durapatite