Six-month safety results of calcium hydroxylapatite for treatment of nasolabial folds in Fitzpatrick skin types IV to VI

Dermatol Surg. 2009 Oct:35 Suppl 2:1641-5. doi: 10.1111/j.1524-4725.2009.01311.x. Epub 2009 Aug 25.

Abstract

Background: 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.

Publication types

  • Clinical Trial
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Biocompatible Materials / administration & dosage
  • Biocompatible Materials / adverse effects*
  • Cosmetic Techniques
  • Dermatologic Agents / administration & dosage
  • Dermatologic Agents / adverse effects*
  • Durapatite / administration & dosage
  • Durapatite / adverse effects*
  • Female
  • Follow-Up Studies
  • Humans
  • Keloid / chemically induced
  • Lip*
  • Male
  • Microspheres
  • Middle Aged
  • New York
  • Nose*
  • Patient Satisfaction
  • Prospective Studies
  • Rejuvenation*
  • Risk Assessment
  • Skin Aging / drug effects*
  • Skin Pigmentation*
  • Treatment Outcome

Substances

  • Biocompatible Materials
  • Dermatologic Agents
  • Durapatite