Considerations for the use of injectable poly-L-lactic acid in people of color.

With demand for minimally invasive cosmetic procedures rising in patients of color, it is becoming increasingly important for clinical dermatologists to be aware of specific needs of these patients. This article therefore reviews considerations for using cosmetic procedures on skin of color, and reports the authors' clinical experience with the use of injectable poly-L-lactic acid (PLLA, Sculptra, Dermik Laboratories, a business of sanofi-aventis U.S. LLC) in this patient population. The authors' experience indicates that patients with skin of color may require an increased interval between treatments; however, with proper attention to patient selection and administration technique, injectable PLLA can be used effectively in this patient group. Controlled clinical studies that include more patients of color are needed to fully assess the benefits and risks of cosmetic products, such as injectable PLLA, in these populations.

Safety of nonanimal stabilized hyaluronic acid dermal fillers in patients with skin of color: a randomized, evaluator-blinded comparative trial.

BACKGROUND: Nonanimal stabilized hyaluronic acid (NASHA) dermal fillers have been used in the United States since 2003 for the treatment of moderate to severe facial wrinkles and folds, such as nasolabial folds. Previous trials with NASHA dermal fillers have included small numbers of patients with pigmented skin. OBJECTIVES: This randomized, evaluator-blinded, split-face trial compared the safety and efficacy of two variable-particle NASHA fillers in the correction of nasolabial folds in patients with Fitzpatrick skin types IV, V, and VI. METHODS AND MATERIALS: One hundred fifty patients (predominantly African American) were enrolled at 10 sites. Patients received one treatment (with an optional touch-up treatment at week 2) with small- and large-particle NASHA gel randomized to the left or right side of the face. Safety was evaluated through patient diaries for the first 2 weeks and physician assessments at 3 days and 2, 6, 12, and 24 weeks after treatment for adverse events (AEs), skin pigmentation changes, and keloid formation. RESULTS: All related AEs were mild or moderate and of limited duration. They included bruising, tenderness, edema, redness, itching, pain, and changes in pigmentation. The incidence of AEs was not different between the 2 preparations, and no patient developed a keloid. There were 3 reported mass formations, 2 of which were infectious in nature. CONCLUSION: In patients with skin of color, NASHA dermal fillers are safe for the correction of moderate to severe facial folds and wrinkles, with no immunogenicity or keloid formation and only mild to moderate AEs occurring around the injection site.

Soft tissue augmentation in skin of color: market growth, available fillers, and successful techniques.

In recent years, people of color have become an increasingly important market force for the cosmetics industry. Product lines have been expanded to accommodate a broader spectrum of skin colors and marketing strategies have been specialized in order to target specific ethnic populations. In addition, it is predicted that people with pigmented skin will eventually comprise a majority of the domestic and international population during the 21st century. Not surprisingly, people of color are increasingly seeking out products and procedures to fight the effects of aging, including an increase in surgical and nonsurgical cosmetic procedures. Among nonsurgical procedures, soft tissue augmentation has experienced dramatic growth. Today, clinicians are performing more and more of these procedures in people of color. As a result of these shifts in the cosmetics industry, clinicians performing soft tissue augmentation require increased expertise in the treatment of ethnic skin. This article reviews the important differences that exist between the appearance of the aging faces of Caucasians and people of color. In addition, soft tissue augmentation strategies and injection techniques that are specific to skin of color are discussed.

Assessment of the safety and efficacy of poly-L-lactic acid for the treatment of HIV-associated facial lipoatrophy.

BACKGROUND: Lipodystrophy syndrome is uniquely associated with the use of highly active antiretroviral therapy (HAART) containing protease inhibitors or nucleoside reverse transcriptase inhibitors. Between 15% and 80% of patients on HAART develop facial lipoatrophy within 10 months of initiating therapy. At present, no ideal treatment strategies have emerged in spite of the psychosocial stress, resulting in depression and isolation in many HIV-infected patients. Most soft tissue fillers seem to be well tolerated; however, various reactions such as allergic reactions, infection, and inflammatory and allergic granulomatous nodules are possible. Poly-L-lactic acid (PLA; New-Fill, Biotech Industry SA, Luxembourg) is currently being used in Europe and is approved by the Food and Drug Administration (FDA) in the United States for soft tissue augmentation in HIV-associated facial lipoatrophy. OBJECTIVE: To determine the safety and efficacy of PLA for dermal enhancement of facial lipoatrophy in immuncompromised HIV-infected patients with prior use of HAART. METHODS: Sixty-one immunocompromised, HIV-infected male patients (52 whites, 7 African Americans, 1 Latino, and 1 Asian) underwent multiple treatment sessions with PLA over a 5-month period for facial lipoatrophy. The severity of facial lipoatrophy was assessed and photographs were taken at baseline and before each treatment session. Periodic monitoring for adverse reactions and degree of improvement were assessed by the patient, the treating physician, and a non-treating physician. RESULTS: At the 6-month follow-up, all 61 immunocompromised HIV patients had a successful outcome, defined as smoothing of the skin with less concavities or depressions, and improved overall appearance in an average of 3 treatment sessions. Although all patients were very pleased with their results, two patients developed persistent asymptomatic palpable intradermal papules in the infraorbital region as a result of the site of placement and concentration of PLA. On long-term follow-up (18 months), 48 of 61 (79%) required an average of 3 visits to achieve the desired enhancement and 13 of 61 (21%) patients requested additional treatment sessions beyond the initial 3 sessions. Although the patient and the physicians rated the level of improvement as "Excellent," the desire for further dermal enhancement was purely subjective. In general, the procedures were well tolerated without the clinical development of adverse reactions. CONCLUSION: The use of PLA to treat facial lipoatrophy resulted in significant and prolonged improvement in HIV-infected patients. The effect was long lasting, for up to 2 years in some patients, depending on when treatment was initiated. There were no reported cases of infection, allergies, or serious adverse reactions, and the treatment was well tolerated.

Evaluating a dental patient for local anesthesia allergy.

The determination of particular allergens with respect to local anesthetics may present difficulty within the realm of clinical dentistry. A case is presented that dramatizes the difficulties in determining the specific allergen after a patient undergoing several episodes of restorative dentistry with several varying regimens of local anesthesia repeatedly reacted with skin rashes and pruritus approximately 36 hours after treatment. The patient was a 76-year-old man with a complex medical history. A challenge procedure performed with a commercial formulation of local anesthesia resulted in a positive delayed hypersensitivity reaction. An additional challenge procedure with cardiac lidocaine resulted in a negative challenge. A latex-induced delayed-type hypersensitivity reaction was suspected but unproven because the patient declined further allergy testing. Therefore, the conclusion was that the allergen was an unknown substance within the commercial local anesthetic formulation.