Clinical Benefits of DaxibotulinumtoxinA for Injection: Beyond Glabellar Line Effacement?

BACKGROUND: Botulinum toxin type A (BoNTA) is standard of care for glabellar lines ameliorization. DaxibotulinumtoxinA for Injection (DAXI) is a new BoNTA with a unique formulation representing the latest advancement in BoNTA technology. There is an unmet need for patients to understand the full potential of BoNTA treatment and new technologies. OBJECTIVE: To update clinical data supporting the use of DAXI for glabellar lines within the context of clinical experience. MATERIALS AND METHODS: A narrative review of the literature and summary of clinical experience with DAXI. RESULTS: The DAXI clinical trial program reflects clinical experience post-FDA approval, with DAXI demonstrating rapid onset, high patient response rates, and extended treatment duration versus conventional BoNTAs. Clinical observations suggest that DAXI has limited diffusion from the injection site, enabling more localized control of muscle activity and greater improvements in wrinkle severity. DAXI enables practitioners to exert greater finesse in their injections and in predicting changes to eyebrow shape and position and achieve improvement in skin quality. CONCLUSION: Advances in BoNTA technology can provide patients with greater options for treatment outcomes. The potential for enhanced localized effects with DAXI may contribute to more precise and targeted effects on muscle activity and additional aesthetic benefits to patients.

Efficacy and Tolerability of Topical 0.1% Stabilized Bioactive Retinol for Photoaging: A Vehicle-Controlled Integrated Analysis.

INTRODUCTION: Chronic exposure to ultraviolet light photoages skin. Retinol, a precursor molecule to retinoic acid that causes less irritation, is available as a nonprescription, cosmetic retinoid and improves collagen production, skin elasticity, and signs of photoaging. Advances in formulation science have allowed the production of stabilized bioactive retinol formulations. This integrated analysis aims to build on previous studies and further examine the comprehensive efficacy and tolerability of topical 0.1% stabilized bioactive retinol. METHODS: This analysis included 6 vehicle-controlled studies of 0.1% stabilized bioactive retinol in women with mild-to-moderate signs of photodamage. Across all studies, the same dermatologist investigator assessed overall photodamage; wrinkles on the forehead, cheeks, and undereye area; crow’s feet wrinkles and fine lines; lack of even skin tone; and brown spots at baseline and weeks 4, 8, and 12 on a numerical scale. Tolerability was also assessed. RESULTS: Participants (retinol, N=237; vehicle, N=234) had a mean (SD) age of 47.4 (6.6) years. Retinol induced greater improvements from baseline in all signs of photoaging vs vehicle as early as week 4 and through 12 weeks of application. Few participants experienced irritation; all events were mild to moderate and transient. The most common signs of irritation were erythema (n=2) and skin scaling/peeling (n=5). CONCLUSIONS: This pooled analysis of 6 vehicle-controlled clinical studies provides new evidence for the efficacy of 0.1% stabilized bioactive retinol in improving signs of photoaging without causing major irritation. Topical 0.1% stabilized bioactive retinol was well tolerated with only a few reported cases of skin irritation. J Drugs Dermatol. 2024;23(4):     doi:10.36849/JDD.8124.

Updating the Fitzpatrick Classification: The Skin Color and Ethnicity Scale.

BACKGROUND: There has been a significant increase in submissions to scientific journals addressing a broad spectrum of medical and surgical conditions in subjects grouped under the classification of "Skin of Color." Authors, reviewers, and editors have struggled with accurate terminology. OBJECTIVE: To update the Fitzpatrick scale to make it more accurate in stratifying various shades of skin color. MATERIALS AND METHODS: A thorough literature review was performed using PubMed and Embase to assess existing skin color scales, and an extensive internet search was conducted using makeup foundation ranges as a starting point for skin tone matching. RESULTS: The research resulted in a consensus that Fitzpatrick types 4 and 5 ratings were the most confusing in that these included a broad range of skin types with different responses to solar radiation, lasers, surgery, and cosmetic products. The authors reached a consensus that subdividing skin types 4 and 5 into "A" and "B" better defined them. The new scale that resulted was labeled the SCE scale (for Skin Color Ethnicity). CONCLUSION: This new updated SCE scale should assist authors in better reporting scientific data in skin of color.

SUPPLEMENT ARTICLE: Effectiveness of Retinol for Skin Health.

As dermatologists, patients often seek our advice for recommendations of cosmetic and beauty care products, particularly those available over-the-counter. The growth in this segment has been tremendous despite the pandemic.

A Large, Open-Label, Phase 3 Safety Study of DaxibotulinumtoxinA for Injection in Glabellar Lines: A Focus on Safety From the SAKURA 3 Study.

BACKGROUND: SAKURA 3 was a Phase 3, open-label, repeat-dose safety study of DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 clinical development program of an aesthetic neuromodulator in glabellar lines. OBJECTIVE: To evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines. METHODS: Eligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 3 treatments over a maximum of 84 weeks. Safety and efficacy were evaluated at least every 4 weeks up to Week 36 (Treatments 1 and 2) and Week 12 (Treatment 3). Select subjects could be retreated after Week 12 if glabellar lines returned to baseline. RESULTS: Safety results are reported for 2,691 subjects, of which 882 received a second treatment and 568 a third. Treatment-related adverse events (AEs) occurred in 17.8% of subjects, which were generally mild and resolved. No serious AEs were treatment-related. Eyelid ptosis occurred in 0.9% of treatments. Adverse events were consistent across treatments and no new safety signals were observed. CONCLUSION: The safety of DAXI in this large open-label safety study confirms the findings from the pivotal Phase 3 trials, providing reassurance in its overall safety profile.

Pain and Bruising Levels After Lip Augmentation: A Comparison of Anterograde and Retrograde Techniques Using an Automated Motorized Injection Device. A Blinded, Prospective, Randomized, Parallel Within-Subject Trial.

BACKGROUND: Dermal fillers for lip augmentation can be injected using various techniques. Although all seem to provide acceptable results, it is not clear which technique is safer, less painful, and provides greater patient comfort. OBJECTIVE: To compare patients' self-reported pain intensity during the injection of hyaluronic acid dermal filler for lip augmentation, with 2 different techniques, anterograde versus retrograde. METHODS AND MATERIALS: Prospective, single-center, within-subject, single-blinded, randomized controlled trial. All subjects received injections in the lip with hyaluronic acid-based filler, each side using the anterograde or retrograde injection technique. An automated motorized injection device was used to ensure a homogeneous deposition flow of the product injected and reduce operator bias. Pain intensity was self-assessed using a 100-mm visual analog scale. Presence and severity of bruising were recorded. RESULTS: Forty-four women (mean age 30.3 years) were randomized. Mean self-reported pain score was 53.1% lower with the anterograde technique than with the retrograde (p < .0001). The anterograde technique had lower rates of site reactions, showed a faster recovery time, and 68.2% of patients favored this technique. CONCLUSION: This study demonstrated that the anterograde technique was less painful, and led to fewer bruising and site reactions than the retrograde technique when using an automated device. LEVEL OF EVIDENCE: I.

Understanding the Female Asian American Facial Aesthetic Patient

Background: As facial aesthetic procedures have become more widely accepted, the racial and ethnic diversity of aesthetic patient populations has increased. Asian Americans represent a growing segment of this population and have specific aesthetic concerns that should be differentiated from the broader Caucasian population. Objective: An online study was designed to survey facial aesthetic concerns, treatment priorities, and future treatment considerations among a US-based population of Asian American women. Materials and Methods: A total of 403 participants ages 30 to 65 years reported perspectives on facial aging, current facial conditions, most bothersome facial areas, most/least likely to be treated first, awareness of treatment options and consideration rates, and motives/barriers impacting the consideration rate of injectable treatments. Results: Treatment interests reflected predominant issues; uneven skin tone, wrinkles, and sun damage. Most bothersome facial areas included the periorbital area, forehead, and submental area, and also among areas designated as most likely to treat first. The majority of participants would consider injectables. However, safety/side effects, cost, and concerns about not looking natural were primary barriers. Conclusion: Understanding the aesthetic concerns and priorities specific to Asian American women may help guide treatment plans more aligned with the goals and expectations of this patient population. J Drugs Dermatol. 2019;18(7):633-641.

Significantly Enhanced Improvement in Dryness, Roughness, Fine Lines and Radiance Following Daily Use of a Novel Multi-Weight Hyaluronic Acid Plus Antioxidant Complex-Based Lotion Compared to a Single-Weight HA Plus Ceramide-Based Lotion.

Objective: Hyaluronic acid (HA) has become a commonly used ingredient in topical moisturizing products; however, limitations of delivery of HA to only the surface of skin have hindered leveraging the full capacity of HA for skin rejuvenation. Here, we aimed to evaluate the clinical benefits of a multi-weight HA plus antioxidant complex-based lotion with SPF 30 compared to a single-weight HA plus ceramide-based lotion with SPF 30. Methods: A double-blind comparative study was conducted on 70 female subjects, aged 25 to 65 years with mild-to-moderate facial dryness and visible fine lines and wrinkles, divided evenly into two groups (n=35 per group). Clinical grading of the face, including dryness, roughness, and fine lines, was assessed after once-daily application for up to eight weeks. Results: Daily use of the multi-weight HA plus antioxidant lotion demonstrated significant improvements in all clinical grading assessments (dryness, roughness, and fine lines) as early as Week 2 compared to baseline. Statistically significant improvements in visible dryness, roughness, and fine lines were greater for the multi-weight HA plus antioxidant lotion compared to the single-weight HA plus ceramide-based lotion. Limitations: The overall small sample size. Conclusion: This study showed the enhanced improvement in dryness, roughness, and fine lines following daily utilization of a novel multi-weight HA plus antioxidant complex-based lotion compared to a single-weight HA plus ceramide-based lotion. These improvements may be attributed to the ability of multi-weight HAs to moisturize the skin surface and penetrate the upper surface layers of the skin, combined with the added benefits of key antioxidants.

Clinical Evaluation of Next-generation, Multi-weight Hyaluronic Acid Plus Antioxidant Complex-based Topical Formulations with Targeted Delivery to Enhance Skin Rejuvenation.

Introduction: Hyaluronic acid (HA) has become a commonly used ingredient in many topical products due to its strong humectant properties and essential role in skin hydration; however, limitations of delivery of HA to only the surface of skin has hindered leveraging the full capacity of HA biology necessary for skin rejuvenation. Here, we describe the clinical efficacy data of a set of novel next-generation, multi-weight HA plus antioxidant complex-based topical formulations with targeted skin delivery to enhance skin rejuvenation. Methods: Four multi-weight HA plus antioxidant complex-based formulations: 1) Multi-Weight HA plus Antioxidant Complex Lotion with SPF 30 (Day Lotion); 2) Multi-Weight HA plus Antioxidant Complex Cream (Night Cream); 3) Multi-Weight HA plus Antioxidant Complex Gel Cream; and 4) Multi-Weight HA plus Antioxidant Complex Boost Serum were clinically evaluated for key attributes including moisturization via corneometer, with clinical grading of: dryness, roughness, fine lines and wrinkles, and following daily use of the individual products for up to eight weeks. Results: Daily use of the multi-weight HA plus antioxidant complex-based formulations demonstrated significant improvements in all parameters evaluated compared to baselines, with changes in moisturization observed within 30 minutes of application, and changes in clinical grading parameters of dryness, roughness, fine lines and wrinkles observed as early as two weeks. Conclusion: These data demonstrate the clinical benefits of daily use of multi-weight HA plus antioxidant complex-based moisturizers for overall improvement in skin health and appearance.

Evaluation of Antioxidants' Ability to Enhance Hyaluronic-acid Based Topical Moisturizers.

Background: Hyaluronic acid (HA) is a unique molecule of the extracellular matrix with multiple biological activities. In skin, HA plays an essential role as a humectant, capable of binding up to 1,000 times its mass with water, providing skin with moisture and viscoelastic properties. HA concentration and synthesis decrease significantly in aging skin, due to exogenous and endogenous factors, including photoaging and HA metabolism. A key driver for HA degradation and reduced concentration is mediated via induction of reactive oxygen species (ROS) and other free radicals. Objective: In this study, we evaluate antioxidant ingredients essential in the development of next-generation HA-based topical formulations aimed at leveraging HA's ability to maximize anti-aging properties. Methods: Two antioxidants, glycine saponin (Glycine soja germ extract) and glycyrrhetinic acid (enoxolone), were evaluated for stimulation of endogenous HA production and inhibition of endogenous hyaluronidase activity, respectively. Results: The antioxidant glycine saponin induced endogenous HA synthesis in fibroblasts, while the antioxidant glycyrrhetinic acid decreased the degradation rate of HA by 54 percent. Conclusion: While HA has been included in numerous topical skin products, critical aspects of HA metabolism, especially in aging skin, have often been overlooked, including decreases in HA synthesis with increasing age, and increases in HA degradation mediated by exogenously induced reactive oxygen species and free radicals and increased enzymatic degradation by endogenous hyaluronidases. Here, we describe a unique approach to inclusion of two antioxidants essential for the development of the next generation of antioxidant complex-based topical skin formulations to limit the signs of aging skin.

Expanding the histologic findings in smallpox-related post-vaccinial non-viral folliculitis.

Post-vaccinial non-viral folliculitis has been recognized in the past decade as a new adverse cutaneous reaction to smallpox vaccination. Contrary to more serious smallpox vaccine reactions, post-vaccinial non-viral folliculitis has a benign course and resolves spontaneously within approximately 7 days. We describe additional histopathologic findings associated with post-vaccinial non-viral folliculitis, which has only been described once previously. New findings include the presence of a neutrophilic or lymphohistiocytic infiltrate that is concentrated around the hair follicles. We compare our findings to the follicular nature of varicella and herpes zoster infections, generating the hypothesis of deposition of vaccinia protein within folliculosebaceous units as a potential pathophysiologic mechanism behind post-vaccinial non-viral folliculitis.

Mohs surgeons' use of topical emollients in postoperative wound care.

BACKGROUND: Although there is no universally accepted topical emollient recommended for wound care, there has been a trend toward minimizing exposure to common culprits of allergic contact dermatitis. OBJECTIVE: To assess the current practices of postoperative emollient use of dermatologic surgeons. METHODS AND MATERIALS: An anonymous 10-question survey on postoperative emollient use for clean surgical wounds was e-mailed to 857 members of the American College of Mohs Surgery. RESULTS: Two hundred ninety-four members (34.3%) responded. After routine closure, the most commonly used topical emollient placed immediately postoperatively was petroleum jelly (53.1%), followed by Aquaphor (Beiersdorf Inc., Wilton, CT) (19.4%) and bacitracin (8.2%) (p < .001). Respondents recommended that patients use the following topical emollients at home to keep the wound moist: petroleum jelly (69.4%), Aquaphor (38.4%), bacitracin (10.0%), mupirocin (9.2%), polymyxin (8.8%), neomycin (2.0%), and gentamicin (1.0%) (p < .001). The three most common topical emollients that were requested not to be used were neomycin (92.8%), polymyxin (44.3%), and bacitracin (44.3%) (p < .001). CONCLUSION: Although emollients with low risk for contact allergy such as petroleum jelly are used more frequently, topical antimicrobials with known sensitizing potential are being applied and recommended for clean surgical wounds. A change in practice is needed to avoid these allergens.

Prophylactic and empiric use of antibiotics in dermatologic surgery: a review of the literature and practical considerations.

BACKGROUND: Although the risk of postoperative infection and bacteremia from dermatologic procedures remains low, many dermatologic surgeons continue to prescribe antibiotics, pre- and postoperatively. This practice can lead to unwanted morbidity and mortality and significantly increases associated healthcare costs and, even more ominously, increases bacterial resistance in the community. OBJECTIVE: To provide a comprehensive overview of antibiotic usage in dermatologic surgery and use evidence-based medicine to provide recommendations for antibiotic usage tailored to microbial pathogens. MATERIALS AND METHODS: A literature review was conducted to provide the most current overview of the guidelines for antibiotic use against surgical site infections, infective endocarditis, and hematogenous joint infection. In addition, recommendations for antibiotic use with implantable materials, such as fillers, and for special populations, such as organ transplant recipients, are provided. RESULTS AND CONCLUSION: We focused on the most common bacterial pathogens related to surgical sites and effective antibiotics for each. In doing so, we seek to limit the unwarranted use of antibiotics in dermatologic surgery.

Clinical application and limitations of the fluorescence in situ hybridization (FISH) assay in the diagnosis and management of melanocytic lesions: a report of 3 cases.

Histopathologic examination is the gold standard for the diagnosis of melanocytic lesions, including melanoma, and guides management options and disease prognosis based on the depth of invasion. Although most melanomas can be readily distinguished from benign nevi, some pigmented lesions are more ambiguous and can be challenging to interpret as truly benign or truly malignant. Unfortunately, misclassification can render severe consequences for the patient, making it imperative to explore further analysis to determine the true nature of an ambiguous lesion. A relatively new technique known as fluorescence in situ hybridization (FISH) has become prevalent in dermatopathology for distinguishing between benign and malignant pigmented lesions; however, there are few reports on the application of FISH results in the clinical setting. We present 3 cases in which a FISH assay was utilized to assist in the diagnosis and management of ambiguous pigmented lesions. We also provide a review of the most recent literature regarding this diagnostic modality.

Current Practices in Hyaluronic Acid Dermal Filler Treatment in Asia Pacific and Practical Approaches to Achieving Safe and Natural-Looking Results.

Complications such as delayed inflammatory reactions (DIRs) and unnatural outcomes can sometimes arise from hyaluronic acid (HA) dermal filler treatments and can be challenging to address. Given the popularity of HA dermal fillers for aesthetic procedures, there is a need for preventive strategies to minimize these complications. Two hundred practitioners from 10 regions in Asia Pacific who administer HA fillers completed a survey on prevention of DIRs and unnatural outcomes. Thirteen global experts convened to evaluate the current practices and propose practical approaches for safe and appropriate use of HA dermal fillers. From the survey, the top three measures used to reduce the risk of DIRs included choosing an appropriate HA filler, aseptic technique, and patient selection. Key strategies employed to achieve natural-looking outcomes were treatment customization, understanding the rheological properties and behavior of different HA fillers, and being conservative in treatment approach. The panel developed a concise reference guide aimed at minimizing the risk of DIRs while achieving natural aesthetic outcomes. Five practical considerations were recommended: patient assessment and individualization of treatment plan, choice of an appropriate HA filler, adequate knowledge of facial anatomy, strict adherence to aseptic methods, and proper injection technique. The panel highlighted the need for education efforts to increase awareness of differential immunogenicity between HA fillers and to improve understanding on the importance of preserving aesthetic individuality for optimal results. These practical insights from the global experts support practitioners in optimizing safety and quality of aesthetic treatment with HA fillers.

The show must go on: Dermatologic procedural education in the era of COVID-19.

COVID-19 procedural restrictions and concerns from both practitioners and patients have led to a decrease in cosmetic procedures performed. Reduced clinic space, the necessity of distancing between people, and patient preference for a smaller care team may restrict trainees from observing, assisting with, or performing procedures. Thus, trainees may be limited in their ability to learn, practice, and meet the required number of cases to achieve competence, subsequently necessitating a sustained demand for alternative methods of learning. In this review, we examine the efforts made thus far by both dermatologists and dermatology organizations to meet the educational procedural needs of trainees and compensate for limitations during the pandemic and highlight areas in which innovation may still be needed.

Skin Quality - A Holistic 360° View: Consensus Results.

INTRODUCTION: Skin quality is an important component of human attractiveness. To date, there are no standardized criteria for good skin quality. To establish a consensus for good skin quality parameters and measurement and treatment options, a virtual skin quality advisory board consisting of a global panel of highly experienced aesthetic dermatologists/aesthetic physicians was convened. METHODS: A total of 10 dermatologists/aesthetic physicians served on the advisory board. A modified version of the Delphi method was used to arrive at consensus. Members accessed an online platform to review statements on skin quality criteria from their peers, including treatment and measurement options, and voted to indicate whether they agreed or disagreed. Statements that did not have agreement were modified and the members voted again. Consensus was defined as: strong consensus = greater than 95% agreement; consensus = 75% to 95% agreement; majority consent = 50% to 75% agreement; no consensus = less than 50% agreement. RESULTS: There was strong consensus that good skin quality is defined as healthy, youthful in appearance (appearing younger than a person's chronological age), undamaged skin and that skin quality can be described across all ethnicities by four emergent perceptual categories (EPCs): skin tone evenness, skin surface evenness, skin firmness, and skin glow. The EPCs can be affected by multiple tissue layers (ie, skin surface quality can stem from and be impacted by deep structures or tissues). This means that topical approaches may not be sufficient. Instead, improving skin quality EPCs can require a multilayer treatment strategy. CONCLUSION: This global advisory board established strong consensus that skin quality can be described by four EPCs, which can help clinicians determine the appropriate treatment option(s) and the tissue or skin layer(s) to address. Skin quality is important to human health and wellbeing and patients' perception for the need for aesthetic treatment.