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.
Subject(s)
Biocompatible Materials/adverse effects , Dermatologic Agents/adverse effects , Durapatite/adverse effects , Lip , Nose , Rejuvenation , Skin Aging/drug effects , Skin Pigmentation , Adult , Aged , Biocompatible Materials/administration & dosage , Cosmetic Techniques , Dermatologic Agents/administration & dosage , Durapatite/administration & dosage , Female , Follow-Up Studies , Humans , Keloid/chemically induced , Male , Microspheres , Middle Aged , New York , Patient Satisfaction , Prospective Studies , Risk Assessment , Treatment OutcomeABSTRACT
Outcomes research examines the delivery of medical care from the patient's perspective, using unique instruments and methodologies. Outcome studies can measure the effectiveness of treatments or interventions in individual patients or in large populations, using prospective observational research designs. The steps in performing outcomes research are as follows: identify and define the disease or procedure of interest, create a staging system for disease severity, identify important co-morbid conditions, choose or design an outcomes instrument to measure treatment outcomes, and design a study to assess outcomes prospectively. Although there is currently a dearth of outcomes instruments available for use in facial plastic and reconstructive surgery, some new instruments are being developed, and even using existing tools outcomes research should prove to be a valuable research tool for facial plastic surgeons to demonstrate improved quality of life and functional status in their patients.
