Jowl Improvement With Injectable Fillers: Jawline Injections Alone Versus Jawline and Cheek Injections.

BACKGROUND: Jowling is a common aesthetic complaint in aging individuals. OBJECTIVE: Injectable filler placed at the lateral jawline will improve the appearance of jowls, as defined by the Merz Aesthetic Jawline Grading Scale (MAJGS). This improvement will be independent of concomitant injection of filler into the lateral cheek. METHODS: Fifteen female subjects with grade 2 to 3 jowls on a scale of 0 to 4 were enrolled to receive either VYC-20L in the mandibular angle/ramus (Group 1) or the mandibular angle/ramus and lateral cheek (Group 2). The subjects were evaluated by a blinded cosmetic dermatologist and themselves at 4 weeks after the last injection. RESULTS: A statistically significant improvement was noted in Group 1 by all blinded reviewers and subjects. Group 2 did not reach statistical significance as evaluated by the blinded dermatologist although did by the subject's rating. The average amount of filler injected per subject was 3.36 mL for group 1 and 8.38 mL for group 2. A novel adverse event was tenderness when chewing lasting for 2 to 3 days. CONCLUSION: Injection of VYC-20L showed statistical improvement in a validated jowl scale when injected at the angle of the mandible and the mandibular ramus, independent of concomitant lateral cheek injections.

Integrating skin color assessments into clinical practice and research: A review of current approaches.

Skin color classification can have importance in skin health, pigmentary disorders, and oncologic condition assessments. It is also critical for evaluating disease course and response to a variety of therapeutic interventions and aids in accurate classification of participants in clinical research studies. A panel of dermatologists conducted a literature review to assess the strengths and limitations of existing classification scales, as well as to compare their preferences and utilities. We identified 17 skin classification systems utilized in dermatologic settings. These systems include a range of parameters such as UV light reactivity, race, ethnicity, and degree of pigmentation. The Fitzpatrick skin type classification is most widely used and validated. However it has numerous limitations including its conflation with race, ethnicity, and skin color. There is a lack of validation data available for the remaining scales. There are significant deficiencies in current skin classification instruments. Consensus-based initiatives to drive the development of validated and reliable tools are critically needed.

Cysteamine Isobionic-Amide Complex Versus Kligman's Formula for the Treatment of Melasma: Equal Efficacy and Rapid Onset of Action.

BACKGROUND: Modified Kligman's formula (mKF) is the gold standard treatment for melasma; however, its prolonged use is not recommended due to side effects. Cysteamine is a potent, safe, and effective depigmenting agent. Here, we conducted a double-blind, randomized, and placebo-controlled clinical trial to assess the efficacy of cysteamine isobionic-amide -- a complex with enhanced depigmenting efficacy -- and compared it to mKF for the treatment of melasma. METHODS: This study involved a total of 80 patients divided into 3 groups: cysteamine-isobionic amide, placebo, or mKF. The modified Melasma Area Severity Index (mMASI) score and spectrophotometric evaluation were conducted at baseline, week 4, week 8, and week 16. Dermatological assessment, patients’ feedback, and satisfaction including quality-of-life scores were also collected. RESULTS: At week 4, cysteamine isobionic-amide and mKF groups showed an equivalent onset of action in terms of mMASI and skin pigmentation contrast reduction. The 2 groups significantly reduced melasma severity and improved the overall skin condition with a comparable efficacy at week 16. Quality of life of melasma patients was significantly improved in the cysteamine isobionic-amide group at week 8 and further at week 16 (P<0.001) compared to the mKF group. Patients’ feedback and satisfaction were higher with the cysteamine isobionic-amide product compared to mKF. CONCLUSION: Cysteamine isobionic-amide provided a rapid onset of action and was as effective as the mKF for the treatment of melasma. The data suggest that cysteamine isobionic-amide could potentially be an acceptable alternative to mKF for the long-term treatment of melasma. J Drugs Dermatol. 2024;23(2):9-16.  doi:10.36849/JDD.7428.

Comparing the Efficacy and Tolerability of Moderate to Severe Hyperpigmentation and Skin Unevenness.

Dyschromia is the result of irregular facial pigmentation. These cutaneous manifestations can have a significant impact on the quality of life of those affected, especially among females and skin of color. In this randomized, double-blinded, two-cell, single-center, 16-week clinical study, all subjects had moderate to severe (scores 4-9 on the modified Griffiths Scale) hyperpigmentation and skin unevenness of the face such that approximately 20% of subjects had post-inflammatory hyperpigmentation (PIH), 40% had overall mottled hyperpigmentation, and 40% had superficial melasma (Superficial Melasma was determined by Wood's Lamp Assessment). Study participants received either Product A (proprietary new formulation - Cysteamine HSA) or Product B (current marketed product - Cyspera®) and used the test product either in the morning or at night, beginning with every other day application, and then advanced to every day, or as tolerated. The results revealed that both Product A (Cysteamine HSA) and Product B (Cyspera®) had statistically significant improvement in facial hyperpigmentation and skin unevenness, however, Product A (Cysteamine HSA) had better tolerability results for scaling, peeling, burning, stinging, erythema, and dryness, indicating that Product A (Cysteamine HSA) outperformed Product B (Cyspera®). J Drugs Dermatol. 2024;23(1):1260-1265.     doi:10.36849/JDD.7584.

Diagnosing Disorders of Facial Erythema.

Identification of specific patterns, shades, and intensity of erythema in the skin has always been critical and fundamental to diagnostic accuracy in dermatology. Erythema is often less noticeable in darker skin types. The interplay of inflammation and variance of skin tone contributes to appreciable differences in the clinical appearance of cutaneous disease in darker complexions. In this article, we discuss common disorders that present with facial erythema in skin of color and offer distinguishing features of each disorder to assist the clinician with diagnosing these conditions in the presence of deeply pigmented skin.

SUPPLEMENT ARTICLE: Scientific and Clinical Insights into the Facial Application of Mineralizing Volcanic Water.

BACKGROUND: The term "exposome" describes the totality of exposures an individual is subjected to from conception to death. Both internal and external exposome factors affect skin health. External exposures that contribute to facial skin aging include solar radiation, air pollution, tobacco smoke, and unbalanced nutrition. The review explores scientific and clinical insights into the exposome impact on facial skin aging and topical mineralizing volcanic water use potential benefits. METHODS: An expert panel of seven dermatologists and two clinical researchers specializing in aesthetic and dermatological indications reviewed and discussed the literature on the exposome and mineralizing volcanic water's role in relation to the exposome. Two virtual advisory boards were conducted between February and May 2021. Following the meetings, an additional systematic literature review explored publications relevant to the exposome, topical essential minerals, and skin health. The results of the two advisory boards, coupled with expert opinion and the outcome of the updated systematic literature review, informed the statements on which the advisors reached a consensus. CONCLUSIONS: A combination of in vivo, in vitro, and clinical data on topical mineralizing volcanic water application indicates that the serum supports the skin's antioxidant defenses and reduces skin inflammation. Additionally, the serum may have benefits as an adjunct for facial dermatoses and post-procedural skincare. J Drugs Dermatol. 2022;21:4(Suppl 1):s3-10.

Skin cancer in women of color: Epidemiology, pathogenesis and clinical manifestations.

Malignant melanoma and nonmelanoma skin cancers (NMSC), which include basal cell carcinoma and squamous cell carcinoma, account for 40% of all neoplasms in white patients, making these cancers the most common malignancy in the United States. Given the large number of NMSC cases in white patients, there is a correspondingly large body of literature addressing various aspects of epidemiology, pathogenesis, and treatment. The incidence of both malignant melanoma and NMSC is well established and remains significantly lower in patients with skin of color (SoC) when compared with white patients. Although there is a lower incidence of skin cancer in SoC, there is often a poorer prognosis among this group. There is even more limited data focusing on women of color, making an accurate determination of incidence and mortality difficult. This gender disparity causes decreased skin cancer awareness and index of suspicion among patients and providers, hindering appropriate evaluation and care. Therefore, there is a need for an increased understanding of skin cancer in women of color. In the traditional sense, SoC refers to people of African, Asian, Native American, Middle Eastern, and Hispanic backgrounds. Patients in these ethnic groups have richly pigmented skin that is usually categorized as Fitzpatrick types III through VI and thus have notable differences in skin disease and presentation compared with fair-skinned individuals. We present this review of skin cancer in women of color to give a reasonably comprehensive representation of the literature to advance our understanding and knowledge in this unique population.

A Double-Blind, Placebo-Controlled, Phase 3b Study of ATX-101 for Reduction of Mild or Extreme Submental Fat.

BACKGROUND: ATX-101 (deoxycholic acid injection) is approved for reduction of moderate or severe submental fat (SMF). OBJECTIVE: To evaluate the efficacy and safety of ATX-101 in subjects with mild or extreme SMF. PATIENTS AND METHODS: Adults with mild or extreme SMF (based on clinician assessment) were randomized to receive ≤6 treatments with ATX-101 or placebo. Efficacy end points, evaluated at 12 weeks after last treatment, included percentage of subjects who achieved ≥1-grade improvement in SMF from baseline based on both clinician and patient assessment (composite CR-1/PR-1 response) as well as multiple subject-reported outcomes. Safety end points included change in skin laxity and incidence of adverse events. RESULTS: Overall, 61.3% of ATX-101-treated subjects versus 6.7% of placebo-treated subjects with mild SMF and 89.3% versus 13.3% of subjects, respectively, with extreme SMF achieved a composite CR-1/PR-1 response (p < .001 for both). ATX-101-treated subjects also reported higher levels of satisfaction and greater reductions in the psychological impact of SMF versus placebo-treated subjects regardless of baseline SMF severity. Skin laxity was unchanged or improved in most of the subjects. Adverse events were mainly mild/moderate, transient, and associated with the injection site. CONCLUSION: ATX-101 was efficacious and well tolerated for reduction of mild or extreme SMF.

Polymethylmethacrylate Collagen Gel-Injectable Dermal Filler for Full Face Atrophic Acne Scar Correction.

BACKGROUND/OBJECTIVES: This trial evaluated the effectiveness and safety of Bellafill for full-face acne scar treatment. PATIENTS AND METHODS: In this open-label, nonrandomized, multicenter pilot study investigating the use of polymethylmethacrylate for full-face atrophic acne scar correction, 42 adult subjects with a mean age of 43 years were treated and assessed for safety and effectiveness at Months 4 and 7. There were no hypersensitivity reactions to pretreatment skin testing or during scar treatments. RESULTS: At 4 and 7 months after initial treatment, 92% and 95% of subjects, respectively, were responders with ≥1-point improvement on the 5-point Acne Scar Assessment Scale. Subjects reported very high levels of improvement on the Global Aesthetic Improvement Scale (GAIS), with 95% of subjects reporting "improved or better" at 4 months and 90% at 7 months. The outcome of the physician GAIS was also high with 92% of patients classified as "improved or better" at 4 months and 97% at 7 months. There were only 2 device-related adverse events, both mild events related to Bellafill skin test (bruising, ecchymosis). There were no serious adverse events in response to the treatment product in this short-term follow-up study. CONCLUSION: Polymethylmethacrylate is effective for treating full-face acne scarring. Clinicaltrials.gov #NCT02642627.

Global epidemiology and clinical spectrum of rosacea, highlighting skin of color: Review and clinical practice experience.

Rosacea has been reported less frequently among individuals with skin of color than in those with white skin, but rosacea is not a rare disease in this population. In fact, rosacea might be underreported and underdiagnosed in populations with skin of color because of the difficulty of discerning erythema and telangiectasia in dark skin. The susceptibility of persons with highly pigmented skin to dermatologic conditions like rosacea, whose triggers include sun exposure, is probably underestimated. Many people with skin of color who have rosacea might experience delayed diagnosis, leading to inappropriate or inadequate treatment; greater morbidity; and uncontrolled, progressive disease with disfiguring manifestations, including phymatous rosacea. In this article, we review the epidemiology of rosacea in skin of color and highlight variations in the clinical presentation of rosacea across the diverse spectrum of patient populations affected. We present strategies to aid in the timely diagnosis and effective treatment of rosacea in patients with skin of color, with an aim of promoting increased awareness of rosacea in these patients and reducing disparities in the management of their disease.

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.

REFINE-1, a Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial With ATX-101, an Injectable Drug for Submental Fat Reduction.

BACKGROUND: ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. OBJECTIVE: To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. METHODS: Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm) or placebo. Coprimary outcome measures were composite ≥1-grade and ≥2-grade improvements in clinician-assessed and subject-assessed SMF severity using validated scales at 12 weeks after last treatment. Magnetic resonance imaging (MRI) provided an objective measure of submental volume reduction. Patient-reported outcomes were assessed. RESULTS: Among 256 ATX-101-treated and 250 placebo-treated subjects, a ≥1-grade composite response was achieved in 70.0% and 18.6%, and a ≥2-grade composite response in 13.4% and 0%, respectively (p < .001 for both). The proportion of MRI responders was more than 8 times higher with ATX-101 than placebo (46.3% vs 5.3%; p < .001). ATX-101-treated subjects reported improvement in the psychological impact of SMF and satisfaction with treatment (p < .001 for all assessments vs placebo). Of note, 55% and 75% of ATX-101-treated subjects reported 1-grade improvement in clinician-assessed SMF after 2 and 4 treatments, respectively. Adverse events (primarily localized to the injection site) were mostly mild or moderate, and transient. Marginal mandibular nerve paresis reported in 4.3% of ATX-101-treated subjects (1.0% of all ATX-101 treatment sessions) was mostly mild, transient, and resolved without sequelae. CONCLUSION: ATX-101 is a safe and efficacious, first-in-class, injectable drug for SMF reduction.

Hair transplantation in the surgical treatment of central centrifugal cicatricial alopecia.

BACKGROUND: Central centrifugal cicatricial alopecia (CCCA) is a progressive primary scarring alopecia that occurs mainly on the vertex of the scalp and expands centrifugally. To date, there is a paucity of published prospective studies reporting successful surgical therapy for CCCA. OBJECTIVE: To evaluate the efficacy of hair transplantation using the round (punch) grafting technique in African American women with CCCA. MATERIALS AND METHODS: We describe 2 African American female patients with CCCA who had endured nearly 5 to 6 years of progressive hair loss on the crown of the scalp. After a scalp biopsy and hair transplant test session, both patients underwent hair transplantation with the use of round grafts. Digital photographs were obtained before and after hair transplantation to determine the hair growth success and response rates. RESULTS: Hair growth was visibly observed at the recipient sites in both patients beginning between 4 to 5 months post-test session. No postoperative scarring in the recipient or donor areas of the scalp were noted in either patient. CONCLUSION: Hair transplantation is a safe well-tolerated procedure to improve hair loss in African American women with end-stage CCCA who histologically display a lack of inflammation on scalp biopsy.

Polypodium leucotomos as an Adjunct Treatment of Pigmentary Disorders.

INTRODUCTION: Extracts of the tropical fern Polypodium leucotomos appear to possess beneficial properties for the skin attributed to the presence of numerous compounds within the extract that have antioxidant and photoprotective properties. Orally administered Polypodium leucotomos may provide protection against the detrimental photoaging effects of sunlight and can also help reduce the frequency and severity of polymorphous light eruption. Polypodium leucotomos has also been shown to be beneficial for the prevention and potential treatment of several aesthetically relevant conditions. OBJECTIVE: The purpose of this review is to investigate the beneficial role of Polypodium leucotomos as an adjunct treatment for vitiligo, melasma, and postinflammatory hyperpigmentation. RESULTS: Based on a review of relevant literature including the results of a randomized, placebo-controlled study, the oral administration of Polypodium leucotomos significantly improved the severity of melasma in women after 12 weeks. Three randomized, double-blind, placebo-controlled studies have demonstrated significant improvements in vitiligo when oral Polypodium leucotomos therapy was combined with psoralens plus ultraviolet A and narrowband ultraviolet B. No controlled studies have assessed the efficacy of Polypodium leucotomos for the treatment of postinflammatory hyperpigmentation; however, its known antioxidant and anti-inflammatory properties and demonstrated effectiveness for melasma support its use for treating this condition. No adverse events have been associated with the use of Polypodium leucotomos. CONCLUSION: In addition to preventing many harmful effects associated with sunlight exposure, orally administered Polypodium leucotomos also appears to provide adjunctive benefits in treating vitiligo, melasma, and may have the potential to help with postinflammatory hyperpigmentation.

A multicenter study of the safety and effectiveness of hyaluronic acid with a cohesive polydensified matrix for treatment of nasolabial folds in subjects with Fitzpatrick skin types IV, V, and VI.

BACKGROUND: Although the use of the hyaluronic acid with cohesive polydensified matrix hyaluronic acid has been well explored in subjects with lighter skin (i.e., Fitzpatrick skin types I, II, and III), further exploration in subjects with Fitzpatrick skin types IV, V, and IV is warranted. The primary purpose of the study was to assess the safety of a cohesive polydensified matrix hyaluronic acid in the correction of nasolabial folds in subjects with Fitzpatrick skin types IV, V and VI, especially assessment of hyperpigmentation, hypopigmentation, and scarring. Effectiveness was also assessed. METHODS: A total of 93 subjects were enrolled in this 24-week investigation at three sites in the United States. All were injected bilaterally for nasolabial fold correction with cohesive polydensified matrix hyaluronic acid. Assessments included the recording of adverse events; injected volumes; wrinkle severity ratings; and global aesthetic improvement by evaluating investigators, treating investigators, and study subjects. RESULTS: Injection of cohesive polydensified matrix hyaluronic acid for the treatment of nasolabial folds in subjects with Fitzpatrick skin types IV, V, and VI showed no evidence of an association with hypopigmentation, hyperpigmentation, or scarring. Adverse events reported were typical of dermal filler injections with respect to type, rate, duration, and severity. CONCLUSION: Cohesive polydensified matrix hyaluronic acid is a safe and well-tolerated dermal filler for subjects with Fitzpatrick skin types IV, V, and VI.

Hair breakage as a presenting sign of early or occult central centrifugal cicatricial alopecia: clinicopathologic findings in 9 patients.

BACKGROUND: Central centrifugal cicatricial alopecia is the most common form of cicatricial alopecia in African American women. Treatment options are limited and mostly aimed at halting further hair loss but rarely result in hair regrowth. Therefore, it is important to recognize early clinical signs, perform a confirmatory biopsy, and begin treatment promptly. We have observed that hair breakage may be a key sign of early central centrifugal cicatricial alopecia, and this association is not clearly described in the literature. OBSERVATIONS: Nine patients with hair breakage on the vertex with or without scalp symptoms underwent scalp biopsies as part of their evaluation. Of these, 8 had histologic samples adequate for complete interpretation: 5 specimens (63%) showed histologic changes typical of central centrifugal cicatricial alopecia, with 1 of these showing advanced end-stage changes of cicatricial alopecia. Two (25%) revealed premature desquamation of the inner root sheath as the sole finding suggestive of early central centrifugal cicatricial alopecia and 1 (13%) was normal. CONCLUSIONS: Although hair breakage can have multiple causes, early central centrifugal cicatricial alopecia must be considered in the differential diagnosis, particularly in women of African ancestry. Histologic evaluation may reveal early or late findings that can help establish the diagnosis.

AbobotulinumtoxinA for reduction of glabellar lines in patients with skin of color: post hoc analysis of pooled clinical trial data.

BACKGROUND: A paucity of research exists on the safety and efficacy of aesthetic medicine products in patients with skin of color (SOC). OBJECTIVE: To compare the effectiveness and tolerability of abobotulinumtoxinA (BoNTA-ABO) for glabellar lines in a subpopulation of patients with SOC with that in white patients. MATERIALS AND METHODS: This post hoc analysis considered pooled safety data from six clinical trials from which were derived a safety population (n = 1,869 white, n = 472 SOC), an efficacy population for a comparison of fixed-dose BoNTA-ABO 50 U in white patients (n = 216) and patients with SOC (n = 117), and an efficacy population for a comparison of BoNTA-ABO adjusted to muscle mass in white (n = 555) and patients with SOC (n = 160). RESULTS: Adverse event rates were similar in white patients and patients with SOC. Onset of effect was similar in patients with SOC and white patients, but the response rate 30 days after treatment was greater in patients with SOC than in white patients. CONCLUSION: Tolerability and effectiveness of treatment BoNTA-ABO for glabellar lines was similar in patients with SOC and white patients.

Differentiating central centrifugal cicatricial alopecia and androgenetic alopecia in african american men: report of three cases.

Central centrifugal cicatricial alopecia is a scarring alopecia that is predominantly seen in African American women, but occurs less frequently in men. The authors present three cases of African American men with biopsy-proven central centrifugal cicatricial alopecia and detail the clinical presentation, histological findings, and treatment regimens. Central centrifugal cicatricial alopecia should be considered in the differential diagnosis when evaluating male patients with vertex hair loss accompanied by scalp symptoms. Physicians should maintain a high index of suspicion in African American men with the appropriate clinical picture and confirm the diagnosis by scalp biopsy. Prompt and appropriate treatment can help halt or slow disease progression.