Efficacy and Safety of DaxibotulinumtoxinA for Injection in the Treatment of Glabellar Lines by Age and Race: Subgroup Analysis of the SAKURA Clinical Trials.

BACKGROUND: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation approved for the treatment of glabellar lines. The efficacy, safety, and extended duration of response of DAXI 40 U for glabellar lines were demonstrated in 2 Phase 3, randomized, double-blind studies (SAKURA 1 and 2) and a Phase 3 open-label trial (SAKURA 3). OBJECTIVES: The aim of this study was to evaluate the efficacy and safety of the first DAXI 40 U treatment received in SAKURA 1, 2, or 3 across age and race subgroups. METHODS: Adults with moderate-to-severe glabellar lines (Investigator Global Assessment-Frown Wrinkle Severity [IGA-FWS] and Patient FWS [PFWS] scales) were evaluated for glabellar line severity for ≤36 weeks after the first DAXI treatment. Efficacy and safety were analyzed by age (18-45, >45-55, and >55 years) and race (Asian, Black and African American, and White). RESULTS: Overall, 2785 patients were included in the efficacy analysis. The proportion of patients achieving none or mild glabellar line severity at maximum frown (IGA-FWS) after DAXI treatment was high in all age and race subgroups (>96% at Week 4). Glabellar line severity of none or mild by composite IGA-FWS and PFWS rating was maintained for a median of 24.0 weeks in all age subgroups, and for 27.0, 25.3, and 24.0 weeks in the Asian, Black and African American, and White subgroups, respectively. Treatment-emergent adverse events were similar across all subgroups. CONCLUSIONS: Consistent with the overall study population, DAXI 40 U demonstrated a high response rate and duration of effect of ≥24 weeks across all age and race subgroups.

An update on cosmetic procedures in people of color. Part 2: Neuromodulators, soft tissue augmentation, chemexfoliating agents, and laser hair reduction.

Recent years have brought forth the undeniable practice gap in dermatology concerning knowledge and experience of cosmetic procedures in people of color (POC). A paucity in the literature regarding evidence-based recommendations for the management of POC undergoing cosmetic procedures and the rise of cosmetic procedures in dermatology serves as a call to action to provide education regarding differences in skin of color that may impact the cosmetic outcomes. To mitigate the current practice gap on the safety, use, and benefits of cosmetic procedures in POC, part 2 will discuss the authors' recommendations and clinical pearls, as well as evidence-based management for neuromodulators, soft tissue augmentation, chemexfoliating agents, and laser hair reduction in POC undergoing cosmetic procedures.

An update on cosmetic procedures in people of color. Part 1: Scientific background, assessment, preprocedure preparation.

Increased life expectancy, focus on appearance, and readily available and accessible cosmetic procedures have served to drive an increase in the number of nonsurgical cosmetic procedures performed in the last 20 years. Demographic shifts in the United States, with increases in diverse populations that seek nonsurgical cosmetic procedures, have resulted in the need for a better understanding of cultural preferences as well as structural and biological differences in the skin of people of color (POC). Although many advances in the form of cosmeceuticals, cosmetics, and photoprotection have been made to address the aesthetic needs of and minimize complications in POC, nonsurgical cosmetic procedures are required to address common aesthetic concerns. Gaps remain in the education of dermatologists regarding the appropriate selection and execution of nonsurgical cosmetic procedures in POC. This educational initiative will facilitate a favorable outcome and optimal cosmetic results for POC.

Global Perspectives of the Patient of Color

Many cultures associate beauty with an even complexion. It has been shown in many reported references, the major cosmetic concern in patients of color is discoloration. This issue addresses discoloration of individuals of color and the use of a multitude of preparations that can blend the complexion. Authors in Asia, Sweden, France, and Brazil discuss the use of injectable deoxycholic acid in nonsubmental regions and hyaluronic acid for skin boosting, an off-label usage or procedures in the United States. Skin boosting improves hydration and the smoothness of the skin. Additionally, international methods of treating cosmetic patients with multiple modalities are discussed.

Three-Dimensional Analysis of Minimally Invasive Vacuum-Assisted Subcision Treatment of Cellulite.

INTRODUCTION: This was a prospective non-randomized observational study of female subjects seeking treatment for cellulite who were consecutively enrolled into a registry. The objective was to evaluate the efficacy and safety of a tissue stabilized-guided subcision device for the treatment of cellulite using three-dimensional (3D) imaging analysis. METHODS: Subjects received a single treatment to the buttocks and/or posterolateral thighs with the study device. Follow-up telephone evaluations were conducted at 3 and 14 days to evaluate safety and 30 and 90 days to evaluate efficacy. Subjects returned to clinic at three months to obtain follow-up two dimensional and 3D imaging. RESULTS: Sixteen women of average age 44.1 years with a total of 291 lesions of cellulite were treated. Thirteen subjects presented for all follow up visits. Physicians graded results an average of 2.23/5 or "much improved" to "improved" with 9 subjects as much or very much improved (69.2%). Blinded assessors graded overall improvement an average of 2.8 (26-75% improvement) with 8 subjects having greater than 50% improvement overall (61.6%). Improvement in dimple depth was graded an average of 2.9, with 9 subjects having greater than 50% improvement (69.2%). Analysis of 3D imaging yielded 67.4% average improvement in negative volume and 58.4% improvement in minimum height of dimples. Most expected treatment effects resolved within three months after treatment. CONCLUSION: Utilizing three-dimensional imaging analysis, investigators quantitatively and objectively demonstrated efficacy of a tissue stabilized-guided subcision device in the treatment of cellulite of the buttocks and thighs. J Drugs Dermatol. 2018;17(9):960-965.

Assessing the Potential Role for Topical Melatonin in an Antiaging Skin Regimen.

BACKGROUND: Melatonin is an endogenous hormone commonly associated with regulation of sleep. However, over the last two decades, research has elucidated a range of effects associated with the compound, including anti-inflammatory, both direct and indirect antioxidant activity, tissue regenerative benefits, and preservation of mitochondrial function. Melatonin's anti-inflammatory and antioxidant support, coupled with its mitochondrial support, make it an intriguing target for use to support skin health. Human skin and hair follicles express functional melatonin receptors. They also engage in substantial melatonin synthesis. By supporting cutaneous homeostasis, melatonin and its metabolites are thought to attenuate carcinogenesis and possibly other pathological processes, including hyperproliferative/inflammatory conditions. The primary extrinsic driver of aging has been considered to be exposure to ultraviolet (UV) light, which is well-established to contribute to sunburn, immunosuppression, skin aging, and carcinogenesis. Topically applied melatonin has been shown to reduce markers of reactive oxygen species formation and to reverse signs of skin aging. As the global population continues to age, photo-damage remains a significant cutaneous concern. While use of sunscreens and UV avoidance strategies are essential to mitigate skin cancer risks, the potential to protect the skin and improve the appearance of photo-damage through the use of topical antioxidant support is appealing. The evidence suggests that melatonin deserves consideration for topical use as an anti-aging and skin protective agent. It is shown to be both safe and effective when topically applied. J Drugs Dermatol. 2018;17(8):966-969.

Considerations When Treating Cosmetic Concerns in Men of Color.

BACKGROUND: Men of color include a diverse population encompassing individuals with Fitzpatrick skin Types IV through VI. Yet, there is a paucity of data describing the cosmetic concerns of this population. OBJECTIVE: To review the basic science of advantages and disadvantages of skin of color and pathophysiology, incidence, and treatment of disorders of cosmetic concern in men of color. METHODS: A MEDLINE search was performed for publications on sex and racial differences in basic science of skin, common disorders in men of color, and evidence-based treatments. RESULTS: There are intrinsic differences in skin and hair of darker-complexioned men, particularly in Hispanics, African Americans, Asians, and Afro-Caribbeans. Advantages of darker skin include increased photoprotection, slowed aging, and a lower incidence of skin cancer. However, the increased content of melanin is associated with myriad dyschromias including melasma and postinflammatory hyperpigmentation (PIH). Additional common skin conditions of concern in men of color include pseudofolliculitis barbae, acne keloidalis nuchae, and keloids. CONCLUSION: A skin color conscious approach should be administered in caring for the cosmetic concerns of men of color that is cognizant of differences in biology of the skin and hair, associated PIH of disorders, and cultural/social practices among this population.

A Randomized, Double-Blind Trial to Investigate the Equivalence of IncobotulinumtoxinA and OnabotulinumtoxinA for Glabellar Frown Lines.

BACKGROUND: IncobotulinumtoxinA and onabotulinumtoxinA are indicated for the temporary improvement in the appearance of glabellar frown lines (GFL). This is the first randomized direct comparator study to date, at the Food and Drug Administration-recommended dose of 20 units (U), for the treatment of GFL. OBJECTIVE: To investigate the dose equivalence of incobotulinumtoxinA (20 U) and onabotulinumtoxinA (20 U) for the treatment of moderate-to-severe GFL. MATERIALS AND METHODS: Prospective, randomized (1:1), double-blinded, parallel-group study in 250 females (18-50 years), employing a single treatment with incobotulinumtoxinA or onabotulinumtoxinA, followed by a 4-month observational period. RESULTS: At the primary efficacy endpoint (1 month after treatment), incobotulinumtoxinA was equivalent to onabotulinumtoxinA in the treatment of GFL at the 20 U dose within the prespecified ± 15% margin of equivalence. Efficacy remained similar between treatment groups through 4 months after treatment as assessed by the independent masked panel and the masked treating physicians. Patient satisfaction ratings were similar between groups and favorable (>90%) throughout. Both treatments were well tolerated. CONCLUSION: Equivalence was demonstrated at the primary endpoint between incobotulinumtoxinA and onabotulinumtoxinA in the treatment of GFL at the 20 U dose at 1 month. Similar efficacy and tolerability profiles were observed through 4 months after treatment.

Skin tone representation in dermatologic direct-to-consumer advertisements: a cross-sectional analysis and call to action.

Background: Direct-to-consumer advertisements (DTCAs) in medical marketing serve as a prominent modality to deliver information to an increasingly diverse audience of consumers and increase prescription sales. In dermatology, advertisements have the potential to shape the public's opinions, aid in the understanding of skin conditions, and raise awareness of available treatments. Objective: To investigate and characterize the representation of skin tones in DTCAs. Methods: Nielsen ratings were utilized to identify the networks most watched by Black viewers in 2022. Programming on NBCUniversal, ABC, CBS, and FOX that aired in the District of Columbia, suburban Maryland, and Northern Virginia from June 2022 to July 2022 was reviewed for DTCAs. DTCAs were then analyzed to determine the skin tones of models and skin conditions depicted on models with darkly pigmented skin. Results: Of the 106 DTCAs related to dermatologic conditions, there were 13 unique advertisements featuring 32 unique models. Four advertisements depicted the skin condition on darkly pigmented skin tones. Using the Monk Skin Tone (MST) scale to assess the 32 unique individuals, only 25% (n = 8) were rated at an MST 7 or above, and 6.25% (n = 2) were rated at an MST 10. Limitations: This study has the limitation of only sampling DTCAs from Washington, District of Columbia which does not fully represent all dermatology-related DTCAs in the United States. Conclusion: Results of this content analysis demonstrate that the number of persons of color within dermatologic DTCAs is 23%, whereas there are 13.6% Black individuals in the 2021 US census. This suggests that DTCAs are becoming more diverse since 2018. However, findings also show that the vast majority of DTCAs do not include models with darkly pigmented skin, and there remains a lack of advertisements depicting skin disease among people of color. Given the role of DTCAs in informing and aiding patients' requests for prescription drugs, representation of all skin tones is essential for this communication to be effective, especially in the field of dermatology.

Telemedicine Alopecia Assessment: Highlighting Patients With Skin of Color.

Alopecia has been one of the more common concerns reported at teledermatology (TD) visits during the COVID-19 pandemic. In light of the growing use of TD, a team of experts were consulted to develop workflows for virtual hair and scalp examinations, with particular consideration for skin of color patients.

Evaluating the Effect of Incobotulinumtoxin A for Glabellar, Forehead, and Crow's Feet Lines Using A High Dilution.

BACKGROUND: As aesthetic preferences have evolved and patients wish their muscles to be relaxed, but not frozen, a higher dilution of incobotulinumtoxinA (INCO) has allowed for increased spread using fewer units, yet no studies to date have investigated the efficacy, longevity, and safety of hyperdiluted INCO. OBJECTIVE: We evaluated the effect of incobotulinumtoxinA (INCO) in glabellar, forehead, and lateral periorbital lines using a high dilution. METHODS: Subjects with moderate-to-severe upper facial lines at rest according to the Merz Aesthetics Scales™ (Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) received 15U of INCO to the glabellar (n=4 injection sites), 10U to the rest of the forehead (n=10 injection sites), and 5U to the lateral periorbital lines (n=3 injection sites/eye). Primary outcomes were physician- and subject-rated improvement at one month using the Global Aesthetic Improvement Scale (GAIS) and changes in line severity using the Merz Aesthetics Scales™. RESULTS: The study included 15 women aged 35 to 65 years. At one month, physician GAIS scores indicated 91.2% of subjects were very much improved and 8.8% were much improved; 91.5%, 78.0%, and 57.6% of participants remained at least improved at four, five, and six months, respectively. Subject GAIS scores at one month were in agreement with physician scores. At one month, an improvement of at least one point in Merz Aesthetics Scales™ scores in glabellar, forehead, and lateral periorbital lines was reported in 88.9%, 98.3%, and 94.8% of participants, respectively. Subject satisfaction was high throughout the study. No treatment-related adverse events were observed. CONCLUSION: Hyperdilute INCO was effective at improving overall appearance and reducing line severity in individuals with moderate-to-severe upper facial lines. Patient satisfaction was maintained up to six months and treatment was well tolerated.

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.

Approach to treatment of medical and cosmetic facial concerns in skin of color patients.

Facial concerns in skin of color (SOC) patients vary and can be a source of emotional and psychological distress. This article discusses 4 common facial concerns in SOC patients: acne, rosacea, facial hyperpigmentation, and cosmetic enhancement. Treatment recommendations are provided as well as management pearls.

Postinflammatory hyperpigmentation: evolving combination treatment strategies.

Postinflammatory hyperpigmentation (PIH) is a common acquired excess of pigment in the epidermal and/or dermal layers of the skin. Lesions persist for extended periods if untreated, thus therapy is warranted. Topical monotherapies include the standard bleaching agent hydroquinone (HQ) as well as retinoids. Recently, several fixed-dose combination products were introduced to the armamentarium: HQ 4%-retinol 0.15% in a microsponge formulation; HQ 4%-retinol 0.3%; mequinol 2%-tretinoin (RA) 0.01%; and fluocinolone acetonide (FA) 0.01%, HQ 4%, and RA 0.05%. Recent findings have suggested that mequinol 2%-RA 0.01% solution is a promising alternative for the treatment of PIH.

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.