Assessing Implicit Bias in Dermatology.

BACKGROUND: Patients with skin of color (SOC), defined as Fitzpatrick skin types IV to VI, and of varying ethnicities are under-represented in dermatology. This includes practitioners, trainees, dermatologic teaching materials, and clinical studies.  Methods: Online survey study to assess dermatologists’ perceptions that could impact patient care. Participants were screened for providers that spent ≥80% of their time in direct patient care; managed ≥100 unique patients per month; and had ≥20% aesthetic patients. RESULTS: A total of 220 dermatologists participated; 50 with SOC, 152 non-SOC, and 18 other. SOC dermatologists had a more diverse patient population by racial/ethnic background, but there was no difference in proportion of patients by Fitzpatrick skin phototype categories. While race/ethnicity is not considered a primary factor in clinical decision making, Fitzpatrick skin type is for many dermatologists. Most dermatologists agree that more diversity in medical training for dermatologic conditions would be beneficial. Dermatologists report that adding before and after photos of different skin types in educational materials and increasing training on cultural competency are likely to be the most effective strategies for improvement. CONCLUSIONS: Although racial/ethnic diversity shows differences based on location of practice and the race of dermatologists, diversity of skin type based on Fitzpatrick scale is virtually identical across practices, illustrating the challenge of categorizing patients by this scale alone. Beer J, Downie J, Noguiera A, et al. Assessing implicit bias in dermatology. J Drugs Dermatol. 2023;22(7):635-640. doi:10.36849/JDD.7435.

Effectiveness of Volbella (VYC-15L) for Infraorbital Hollowing: Patient-Reported Outcomes From a Prospective, Multicenter, Single-Blind, Randomized, Controlled Study.

BACKGROUND: Infraorbital hollowing can be addressed with hyaluronic acid soft tissue fillers. A prospective, multicenter, evaluator-blinded, randomized, controlled study (NCT03418545) demonstrated the safety and effectiveness of Juvéderm Volbella XC (VYC-15L, Allergan Aesthetics, an AbbVie company, Irvine, CA) in adults seeking correction for infraorbital hollows. OBJECTIVE: The objective of the current analysis was to examine patient-reported outcomes from the clinical study. METHODS: Participants were randomly assigned 3:1 to the VYC-15L treatment group or the no-treatment control group. Outcome measurements included: evaluating investigator (EI)- and participant-assessed Global Aesthetic Improvement Scale (GAIS) scores, as well as participant responses to the FACE-Q Appraisal of Lower Eyelids, questions on treatment satisfaction, the extent to which patients were bothered by dark circles under their eyes, and willingness to recommend treatment to a friend. RESULTS: The modified intent-to-treat population included 135 participants (median age, 47 years; 91.9% female). At Month 3, the majority of VYC-15L-treated participants showed improvements in the EI- and participant-assessed GAIS. The mean change from baseline to Month 3 score (32.7% increase) showed statistically significant improvement (mean [standard deviation], 17.8 [19.8], P < .0001). At Months 3 and 12 posttreatment, most VYC-15L-treated participants reported feeling satisfied with treatment and not feeling moderately or very bothered by dark circles under their eyes, and would recommend treatment to a friend. CONCLUSIONS: The current analysis demonstrated the effectiveness of VYC-15L treatment to reduce infraorbital hollowing and to improve overall satisfaction based on validated patient-reported outcomes. Participant-assessed improvements aligned with EI-assessed outcomes and lasted for 1 year.

Efficacy and Safety of Tapencarium (RZL-012) in Submental Fat Reduction.

BACKGROUND: Tapencarium (RZL-012) (5-(3.6-dibromo-9H-carbazol-9-yl)-N, N, N-trimethylpentan-1-aminium chloride) is a novel injectable synthetic molecule with cytolytic properties, capable of reducing subcutaneous fat volume. OBJECTIVES: The goal of this 3-armed, randomized, double-blind, placebo-controlled phase 2b study was to determine the safety and efficacy of low- and high-dose RZL-012 vs placebo on submental fat (SMF) reduction. METHODS: Patients (n = 151, age 18-65 years) with excess SMF received a single treatment session of RZL-012 or placebo in the submental area, after which they were monitored for 84 days. SMF was assessed at baseline and after dosing with newly developed scales, namely the Clinician Chin Assessment Tool (C-CAT) and Subject Chin Assessment Tool (S-CAT). SMF was also assessed by magnetic resonance imaging (MRI) at screening and on Day 84 after treatment. RESULTS: The proportion of patients who had a 1-grade or 2-grade improvement in C-CAT and/or S-CAT on Day 84 vs baseline was significantly higher in the high-dose RZL-012 group vs the placebo group (P < .002). The relative percentage reduction in MRI-measured SMF volume (Day 84 vs screening) was significantly greater in the high-dose RZL-012 group vs the low-dose RZL-012 or the placebo group (P < .0001). Local injection site reactions were the most common adverse events (AEs). CONCLUSIONS: A single administration of RZL-012 into SMF resulted in significant improvement in submental appearance as assessed by clinicians, patients, and MRI. From a safety perspective, there were no serious AEs and no clinically significant changes in vital signs or laboratory tests over the course of the study.

An Open-Label Study Evaluating the Periorbital Skin Rejuvenation Efficacy of a Cosmeceutical Containing Methyl Estradiolpropanoate (MEP) in Women With Estrogen Deficient Skin (EDS).

BACKGROUND: A cosmeceutical topical formulation containing a non-hormonal estrogen receptor activator, Methyl Estradiolpropanoate (MEP), has been developed to address periorbital skin aging in post-menopausal women with estrogen-deficient skin (EDS). OBJECTIVE: The primary objective of the study was to evaluate the efficacy of Emepelle Eye Cream® (Biopelle, Ferndale Pharma Group, Ferndale, MI, USA) for the rejuvenation of the periorbital skin areas in women EDS. The secondary objectives were to assess the tolerability and satisfaction with Emepelle Eye Cream as assessed by the clinical investigator and the participants. METHODS: Clinical improvement (ie, change from baseline visit) to the end of study topical application in the periorbital areas were assessed by the clinical investigator using the clinician-rated quality of periorbital skin area visual scoring scale and by the participant using the participant’s self-evaluation of the quality of periorbital skin area questionnaire. Secondary objectives and endpoints were assessed using a subject Quality of Life (QoL) evaluation, a clinician- and a participant-evaluation of tolerability and side effects, and the C-GAIS and P-GAIS questionnaires. Baseline scores were compared to scores at the follow-up visits. RESULTS: Clinician evaluations included a Global Aesthetic Improvement Scale (GAIS) rating of periorbital skin areas using a 6-point rating scale as well as tolerability and side effects. The averaged clinical GAIS improvement for all subjects who completed the study improved by 21%. The mean clinician GAIS score at study completion was 2.7, and 26 of the 31 subjects who completed the study showed improvement. A clinician GAIS score of 1 (very much improved) was observed in 3 study subjects. The averaged subject improvement results included improvements in each category at the primary endpoint. The subjects reported that their satisfaction with their periorbital appearance improved by 47% as compared to before treatment. The product was well tolerated by all subjects and no significant side effects were reported. CONCLUSION: In an open label study of 31 female subjects who had been amenorrheic for at least one year, topical application of Emepelle Eye Cream for periorbital skin rejuvenation was effective and well-tolerated. J Drugs Dermatol. 2022;21(11):1185-1190. doi:10.36849/JDD.7279.

Diversity in Academic Dermatology.

The American Medical Association recently declared racism to be a public health threat. It declared that “Racism negatively impacts and exacerbates the health inequities among historically marginalized communities”.1 The New England Journal of Medicine echoed this declaration in a recent article that included goals for making medicine more diverse by transforming “the ranks of institutional research leadership, faculty, trainees, and staff to reflect the demographic diversity of the communities their organizations serve.”2 The article also calls for more transparent selection criteria for choosing leaders in medicine. Necessary changes are articulated and provide a pathway towards more equality in medicine. One subspecialty in the field of medicine (dermatology) lacks the type of diversity one would expect from physicians who study the skin. Although the problem has been discussed for years, it has yet to be rectified. J Drugs Dermatol. 2022;21(5):674-676. doi:10.36849/JDD.6899.

The Second of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients.

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety outcomes were evaluated throughout the study. RESULTS: The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug-related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Eight patients (1.4%) experienced study drug-related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes.

Racial and Ethnic Differences in Self-Assessed Facial Aging in Women: Results From a Multinational Study.

BACKGROUND: Racial/ethnic variations in skin structure and function may contribute to differential manifestations of facial aging in various races/ethnicities. OBJECTIVE: To examine self-assessed differences in facial aging in women by race/ethnicity and Fitzpatrick skin phototypes. METHODS: Women aged 18 to 75 years in the United States, Canada, the United Kingdom, and Australia compared their features against photonumeric rating scales depicting degrees of severity for 10 facial aging characteristics. Impact of race/ethnicity (black, Hispanic, Asian, and Caucasian) and skin phototypes on severity was assessed. RESULTS: In total, 3,267 women completed the study. Black women reported the least severe facial aging; Caucasian women reported the most severe facial aging, with Asian and Hispanic women falling between these groups. Similarly, women with a skin phototype V/VI reported lesser aging severity than women with phototypes I through IV. More than 30% of black women did not report the presence of moderate/severe aging of facial areas until 60 to 79 years; most Hispanics and Asians did not report moderate/severe facial aging until 50 to 69 years and Caucasians, 40 to 59 years. CONCLUSION: In this diverse sample, black women reported less severe aging of facial features compared with Hispanic, Asian, and Caucasian women. These results were supported by Fitzpatrick skin phototype analyses.

Lip and Perioral Enhancement With Hyaluronic Acid Dermal Fillers in Individuals With Skin of Color.

BACKGROUND: Individuals with skin of color are underrepresented in studies of lip and perioral enhancement. OBJECTIVE: To examine the effectiveness and safety of hyaluronic acid (HA) dermal filler treatment for lip and perioral enhancement in subjects with skin of color. METHODS: Data were pooled from subjects with Fitzpatrick skin phototypes IV, V, or VI in 2 pivotal studies of HA dermal fillers. Photonumeric scales were used to assess lip fullness (5-point scale) and perioral lines and oral commissures severity (each 4-point scales). Safety was assessed by injection site responses recorded in patient diaries and adverse events (AEs). RESULTS: The cohort comprised 72 subjects (median age: 49.5 years; 95.8% female). Mean lip fullness improved from baseline by 1.1 points at 3 months after treatment; 85.0% of subjects were responders (≥1-point improvement). Of subjects treated for perioral lines (n = 12) and oral commissures (n = 56), 90.9% and 46.4%, respectively, were responders. Injection site responses were generally mild or moderate in severity, resolved within 2 weeks, and were consistent with those expected for HA dermal filler treatment. The most common AEs were injection site mass (19.4%) and bruising (12.5%). CONCLUSION: Lip and perioral enhancement with HA dermal fillers is effective and safe in subjects with skin of color.

Understanding the Female African American Facial Aesthetic Patient

BACKGROUND: The patient populations seeking facial aesthetic treatments is expanding in terms of racial, ethnic, and cultural diversity. While treatment of facial aging patterns among white women is well-documented, far less information describes the aesthetic needs of the African American patient. OBJECTIVE: An online study was conducted to survey facial aesthetic concerns and treatment priorities among US-based population of African American women. MATERIALS AND METHODS: A total of 401 female African American participants ages 30 to 65 years reported their attitudes toward facial aging, current facial conditions, most bothersome facial areas and areas most/least likely to be treated first, awareness of treatment options and their consideration rates, and motives and barriers factoring into consideration of injectable treatments. RESULTS: Uneven skin tone/color (57%) and dark circles under the eyes (48%) were the most frequently-reported facial concerns. Other common bothersome facial areas affected by signs of aging were the submental area, periorbital area, forehead lines, and chin. Similarly, areas given greater priority with respect to future treatment included the periorbital area, submental area, and forehead lines. With advancing age, priorities heightened for the mid and lower facial areas, which included the nasolabial folds, chin, and oral commissures. Although the majority of participants would consider injectables, cost, and safety/side effects were cited as frequent concerns. CONCLUSION: For African American women, concerns about facial aging may be less about fine lines and wrinkles caused by increasing skin laxity, and more about pigmentary concerns and shifts in underlying soft tissue volume. J Drugs Dermatol. 2019;18(9):858-866.

Myths and Knowledge Gaps in the Aesthetic Treatment of Patients With Skin of Color

Background: Misperceptions about facial aesthetic treatments in individuals with skin of color (SOC) may influence treatment selection. Objective: We aimed to identify knowledge gaps and myths concerning facial aesthetic treatment in individuals with SOC. Methods: A PubMed search identified articles concerning patients with SOC receiving facial aesthetic treatments. The experience of experts in aesthetic treatment of patients with SOC was also considered. Results: Knowledge gaps included not seeking injectable filler treatment of lips, risk of developing keloids with injectable filler treatment, risk of hyperpigmentation precluding surgical procedures and nonsurgical injectable filler treatment, melasma being a minor cosmetic concern with limited treatments, and racial/ethnic groups being homogeneous with respect to facial characteristics and aesthetic concerns. Dispelled myths included perceptions that: individuals with SOC do not need sunscreen; dermal fillers and neuromodulators are not necessary or useful for patients with darker skin; laser treatments cannot be used on darker skin; facial products are unnecessary; and only medical providers with SOC can understand how to treat patients with SOC. Conclusions: Knowledge gaps and myths concerning facial aesthetic treatment in individuals with SOC exist. These patients may undergo various facial aesthetic procedures safely and effectively, as long as nuances in treatment approaches are recognized. J Drugs Dermatol. 2019;18(7):616-622.

Efficacy, Safety, and Tolerability of Topical Dapsone Gel, 7.5% for Treatment of Acne Vulgaris by Fitzpatrick Skin Phototype.

BACKGROUND: Acne vulgaris (acne) is prevalent in individuals with skin of color, often with more frequent sequelae than in patients with lighter skin color. It is important to determine if there are also differences in response to medications. OBJECTIVE: This study evaluated the efficacy and tolerability of once-daily dapsone gel, 7.5% in patients with acne, stratified by Fitzpatrick skin phototype. METHODS: Data were pooled from 2 identically designed, phase 3, randomized, double-blind, vehicle-controlled studies in patients aged 12 years and older with moderate acne. Patients applied dapsone gel, 7.5% or vehicle once daily for 12 weeks. Efficacy was evaluated using the Global Acne Assessment Score (GAAS), lesion counts, and Acne Symptom and Impact Scale (ASIS); adverse events (AEs) and tolerability were also assessed. RESULTS: This analysis included 2216 patients with skin phototypes I-III and 2111 with types IV-VI. Dapsone gel, 7.5% significantly improved acne severity versus vehicle in both skin phototype subgroups, as determined by the percentage of patients with at least a 1-grade improvement in GAAS and mean change from baseline in GAAS (both, P less than .0001) at week 12 versus baseline. Dapsone gel, 7.5% significantly reduced inflammatory, comedonal, and total lesions in skin phototypes I-III (P less than .001) and IV-VI (P less than equal to .01) versus vehicle. Improvements in inflammatory lesions occurred first, with generally similar patterns of improvement seen over time in GAAS, comedonal lesions, and ASIS domains. The incidence of AEs was similar in both skin phototype subgroups and between study medications. Local scaling, erythema, stinging/burning, and dryness were rated "none" by most patients in both treatment groups and skin phototype subgroups. CONCLUSION: Once-daily dapsone gel, 7.5% was effective, safe, and well tolerated in patients with all skin phototypes who were treated for moderate acne. J Drugs Dermatol. 2018;17(2):160-167.

Combination of In-Office Chemical Peels With a Topical Comprehensive Pigmentation Control Product in Skin of Color Subjects With Facial Hyperpigmentation.

Dyschromia is one of the primary complaints for patients with skin of color. Treatments need to achieve a balance between tolerability and efficacy to address existing hyperpigmentation without causing additional damage that could trigger post-inflammatory hyperpigmentation (PIH). An open-label, single-center study was conducted to assess the efficacy of a novel comprehensive pigmentation control serum (LYT2) combined with a series of three very superficial chemical peels (VP) in skin of color subjects. Seventeen female and male subjects aged 36 to 69 years with Fitzpatrick Skin Types III-VI and moderate to severe facial hyperpigmentation were enrolled in the 12-week clinical study. Subjects identified as Asian, Hispanic, African American, or Caucasian ethnicities. Subjects received a series of 3 VP treatments every 4 weeks. LYT2 was applied twice-daily in between VP treatments. Investigator assessments for overall hyperpigmentation, overall photodamage, and skin tone unevenness, as well as standardized digital photography and subject self-assessment questionnaires were conducted at all visits (baseline and weeks 4, 8, and 12). In vivo reflectance confocal microscopy (RCM) of a target lesion was conducted (in a subset of subjects) at baseline and week 12. Fourteen subjects completed the study. The treatment regimen provided statistically significant improvements in all efficacy parameters at weeks 8 and 12 (all P less than equal to 0.03, student's t-test). Standardized digital photography and RCM images support the improvements in overall hyperpigmentation observed by the investigator. At the end of treatment, the regimen was highly rated by subjects with 100% of subjects (strongly agree/agree) that the combination "decreased the appearance of uneven skin tone and discolorations" and "reduced the appearance of sun damage." In addition to this clinical study, independent case studies with this combination treatment regimen at a separate study site were also conducted with results that corroborate the formal clinical study findings. The comprehensive results from these studies suggest that the combination of a comprehensive pigmentation control serum with a series of 3 very superficial chemical peels may provide an effective treatment approach for hyperpigmentation in skin of color patients.

J Drugs Dermatol. 2017;16(4):301-306.

Treatment Response With Once-Daily Topical Dapsone Gel, 7.5% for Acne Vulgaris: Subgroup Analysis of Pooled Data from Two Randomized, Double-Blind Stu.

BACKGROUND: Acne vulgaris has varying physical and psychological effects in men and women of different ages, races, and ethnicities.

OBJECTIVE: This analysis assessed the relationship of age, sex, and race to treatment response with once-daily topical dapsone gel, 7.5%.

METHODS: We conducted a pooled subgroup analysis of 2 randomized, double-blind, vehicle-controlled clinical trials conducted in the US and Canada. The studies included patients with 20 to 50 inflammatory and 30 to 100 noninflammatory facial lesions, and a Global Acne Assessment Score (GAAS) of 3 (moderate). Pooled data (N=4340) were analyzed by age (12-17 and ≥18 years), sex, and race (Caucasian and non-Caucasian) for GAAS success (score of 0 [none] or 1 [minimal]) and mean percent change from baseline in inflammatory, noninflammatory, and total lesion counts. The impact of age and sex on treatment response was examined using multivariate analysis. Adverse events were analyzed by subgroups.

RESULTS: Treatment responses with dapsone gel, 7.5% were greater overall and for all subgroups versus vehicle. GAAS success rates and mean decrease in all lesion counts with dapsone gel, 7.5% were greater in older (aged ≥18 years) versus younger patients, and for females versus males. Treatment response with dapsone gel, 7.5% in racial subgroups was similar. Multivariate analysis showed statistical significance for age group and sex as predictors of GAAS success (P less than equal to .005) and reduction in lesion counts (P less than equal to .025). Adverse events were similar across subgroups.

CONCLUSIONS: Older age (≥18 years) and female sex were predictors of treatment response. These subgroups tended to have greater acne improvement in subgroup comparisons. Caucasian and non-Caucasian patients had similar responses. The safety profile of dapsone gel, 7.5% was similar across subgroups.

J Drugs Dermatol. 2017;16(6):591-598.

Contactless Abdominal Fat Reduction With Selective RF™ Evaluated by Magnetic Resonance Imaging (MRI): Case Study.

BACKGROUND: Noninvasive body shaping methods seem to be an ascending part of the aesthetics market. As a result, the pressure to develop reliable methods for the collection and presentation of their results has also increased. The most used techniques currently include ultrasound measurements of fat thickness in the treated area, caliper measurements, bioimpedance-based scale measurements or circumferential tape measurements. Although these are the most used techniques, almost all of them have some limitations in reproducibility and/or accuracy. This study shows Magnetic Resonance Imaging (MRI) as the new method for the presentation of results in the body shaping industry. MATERIALS AND METHODS: Six subjects were treated by a contactless selective radiofrequency device (BTL Vanquish ME, BTL Industries Inc., Boston, MA). The MRI fat thickness was measured at the baseline and at 4-weeks following the treatment. In addition to MRI images and measurements, digital photographs and anthropometric evaluations such as weight, abdominal circumference, and caliper fat thickness measurements were recorded. Abdominal fat thickness measurements from the MRI were performed from the same slices determined by the same tissue artefacts. RESULTS: The MRI fat thickness difference between the baseline measurement and follow up visit showed an average reduction of 5.36 mm as calculated from the data of 5 subjects. One subject dropped out of study due to non-study related issues. The results were statistically significant based on the Student's T-test evaluation. CONCLUSIONS: Magnetic resonance imaging abdominal fat thickness measurements seems to be the best method for the evaluation of fat thickness reduction after non-invasive body shaping treatments. In this study, this method shows average fat thickness reduction of 5.36 mm while the weight of the subjects didn't change significantly. A large spot size measuring 1317 cm(2) (204 square inches) covers the abdomen flank to flank. The average thickness of 5.36 mm of the fat layer reduced under the applicator translates into significant cumulative circumferential reduction. The reduction was not related with dieting.

Rejuvenating Hydrator: Restoring Epidermal Hyaluronic Acid Homeostasis With Instant Benefits.

Skin aging is a combination of multifactorial mechanisms that are not fully understood. Intrinsic and extrinsic factors modulate skin aging, activating distinctive processes that share similar molecular pathways. One of the main characteristics of youthful skin is its large capacity to retain water, and this decreases significantly as we age. A key molecule involved in maintaining skin hydration is hyaluronic acid (HA). Concentration of HA in the skin is determined by the complex balance between its synthesis, deposition, association with cellular structures, and degradation. HA bio-equivalency and bio-compatibility have been fundamental in keeping this macromolecule as the favorite of the skincare industry for decades. Scientific evidence now shows that topically applied HA is unable to penetrate the skin and is rapidly degraded on the skin surface. SkinMedica's HA5 Rejuvenating Hydrator (SkinMedica Inc., an Allergan company, Irvine, CA) promotes restoration of endogenous epidermal HA homeostasis and provides instant smoothing and hydration of the skin. These dual benefits are accomplished through the combination of 2 breakthrough technologies: 1) a unique blend of actives powered by SkinMedica proprietary flower-derived stem cell extract that restores the endogenous production of HA; and 2) a proprietary mix of 5 HA forms that plump the skin, decreasing the appearance of fine lines/wrinkles. Pre-clinical studies demonstrated that HA5 induces expression of key epidermal differentiation and barrier markers as well as epidermal HA synthases. A decrease expression of hyaluronidases was also observed upon HA5 application. Initial clinical studies showed that within 15 minutes of application, HA5 instantly improves the appearance of fine lines/wrinkles and skin hydration. Subjects that continue using HA5 (for 8 weeks) demonstrated significant improvements in fine lines/wrinkles, tactile roughness, and skin hydration. In summary, the blend of these 2 key technologies present in HA5 promotes restoration of endogenous epidermal HA while delivering instant smoothing effects.

Safety and Effectiveness of the Hyaluronic Acid Filler, HYC-24L, for Lip and Perioral Augmentation.

BACKGROUND: Hyaluronic acid gels are increasingly used for augmentation of the lips. OBJECTIVE: To assess the safety and effectiveness of Juvéderm Ultra XC, a 24 mg/mL hyaluronic acid gel containing 0.3% (wt/wt) lidocaine (HYC-24L), for augmentation of the lips. METHODS: This ongoing, multicenter, single-blind study randomized 213 subjects to the treatment group (n = 157) or concurrent no-treatment control group that received delayed treatment (n = 56). The primary effectiveness endpoint was the responder rate (≥1 point improvement from baseline) based on the blinded evaluating investigator's assessment of the subject's overall lip fullness (or fullness of the eligible lip) using the validated Allergan 5-point Lip Fullness Scale. To meet this endpoint, the treatment group had to have a responder rate ≥60% and significantly greater than the treatment control group at Month 3. RESULTS: The primary endpoint was met, with a 79.1% responder rate for the treatment group and 26.1% for the treatment control group (p < 0.0001). More than half of subjects (56.4%) maintained treatment response for 12 months. Common injection site responses were swelling, bruising, and firmness; most were of mild or moderate severity. CONCLUSION: HYC-24L is safe and effective for aesthetic lip augmentation, with results lasting up to 1 year.

Development and Validation of a Composite Skin Quality Scale.

Background: The increasing demand for skin quality interventions in aesthetic medicine underscores the necessity for objective, evidence-based assessment tools that may be used to evaluate novel interventions or devices. Objectives: To develop and validate a 5-point photonumeric rating scale for assessing overall skin quality, including radiance, color evenness, and smoothness. Methods: The IBSA (Institut Biochimique SA) Composite Skin Quality Scale was developed and underwent live validation with 88 real-world patients, chosen to encompass a broad spectrum of skin qualities and Fitzpatrick skin types. Scale validation was performed by board-certified plastic surgeons and dermatologists over 2 rounds, 2 weeks apart. Reliability was assessed through intrarater and interrater agreements, utilizing weighted kappa statistics and intraclass correlation coefficient (ICC). The scale's ability to discern a clinically relevant 1-grade difference was evaluated with 72 photo pairs. Results: Combined intrarater reliability results showed weighted kappa values of 0.812 (right side) and 0.815 (left side) and an ICC of 0.903 for both sides, indicating an almost perfect agreement. Interrater reliability ranged from substantial to almost perfect, with kappa coefficients between 0.654 and 0.853 and ICCs between 0.657 and 0.855 across all rater pairs in both rounds. The ability to detect a clinically relevant 1-point difference using the scale was established. Conclusions: Integrating various key aspects of skin quality, the IBSA Composite Skin Quality Scale is a clinically relevant and highly reliable tool, suitable for skin assessment in clinical studies of new aesthetic technologies and products.

A randomized, placebo-controlled, double-blind phase III trial investigating the efficacy and safety of incobotulinumtoxinA in the treatment of glabellar frown lines using a stringent composite endpoint.

BACKGROUND: A prospective, randomized, double-blind, multicenter, Phase III trial of incobotulinumtoxinA using new Food and Drug Administration endpoints. OBJECTIVE: To investigate the efficacy and safety of a single dose of incobotulinumtoxinA for the treatment of glabellar frown lines. MATERIALS AND METHODS: Two hundred seventy-one subjects with moderate to severe glabellar frown lines at maximum frown-as assessed by an investigator according to the facial wrinkle scale (FWS)-were randomized 2:1 to receive one treatment of 20 U of incobotulinumtoxinA or placebo, respectively, and assessed over 120 days. The primary efficacy variable was a composite endpoint consisting of patients who were 2-point or more responders at maximum frown on Day 30 according to the investigator's rating on the FWS, and 2-point or more responders at maximum frown on Day 30 according to the patient's assessment on a 4-point scale. Safety analyses were performed throughout the study. RESULTS: IncobotulinumtoxinA was statistically significantly more efficacious than placebo using a new rigorous composite endpoint (p < .0001). CONCLUSION: A single dose of 20 U of incobotulinumtoxinA is superior to placebo in the treatment of glabellar frown lines at Day 30 and is well-tolerated.