Effectiveness and Safety of a New Hyaluronic Acid Injectable for Augmentation and Correction of Chin Retrusion.

BACKGROUND: A hyaluronic acid (HA) filler intended for non-surgical improvement of chin appearance should ideally be of high strength/firmness (high G') to allow for deep injections on the bone. HASHA (Restylane Shaype) is a new hyaluronic acid (HA) injectable with high G' and high HA concentration (25 mg/mL), engineered by the new NASHA-HD (High Definition) technology. HASHA is suitable to be placed periosteally, aiming to mimic the natural shape of the bony chin. This pivotal clinical investigation evaluated effectiveness and safety of HASHA for augmentation and correction of chin retrusion.  Methods: Subjects 18 years or older with mild or moderate chin retrusion by the Galderma Chin Retrusion Scale (GCRS), were randomized 3:1 to HASHA (n=103) or no treatment (n=37). Assessments included GCRS (blinded evaluator), aesthetic improvement (Global Aesthetic Improvement Scale [GAIS]), subject satisfaction, and safety.  Results: GCRS responder rate (1-grade or greater improvement from baseline) was significantly higher for HASHA (83.3%) versus controls (10.8%) at month 3 (P<0.001) and maintained through month 12 (P<0.001). Aesthetic improvement was high throughout the study in the HASHA group, according to investigators (97% or greater) and subjects (89% or greater). Overall, subject satisfaction was high at month 3 and maintained at month 12. Product- or injection-related adverse events were mostly mild or moderate and transient. No product- or injection-related serious adverse events were reported. CONCLUSIONS: HASHA, a new NASHA-HD injectable with extra strength/firmness, was safe and effective for chin augmentation and correction of chin retrusion, with high aesthetic improvement and subject satisfaction throughout 12 months. J Drugs Dermatol. 2024;23(4):255-261.     doi:10.36849/JDD.8145.

Increasing Precision When Targeting the Depressor Anguli Oris (DAO) Muscle With Neuromodulators - An Ultrasound-Based Investigation.

BACKGROUND: Neuromodulator treatments of the perioral region are increasingly popular and aim to modulate the position of the modiolus. The predominantly targeted muscle is the depressor anguli oris (DAO) which allows for the modiolus to reposition cranially once temporarily relaxed. OBJECTIVES: To identify the precise anatomic position of the DAO in relation to the Marionette Line for increasing precision and reducing adverse events during neuromodulator treatments. METHODS: A total of n = 80 DAO muscles were investigated in n = 40 healthy, toxin naïve volunteers (11 males, 29 females) having a mean age of 48.15 (15) years and a mean body mass index of 24.07 (3.7) kg/m2. The location of the DAO in relation to the labiomandibular sulcus (LMS), its depth, extent, and thickness were investigated with high frequency ultrasound imaging. RESULTS: The skin surface projection of the LMS separates the DAO into medial and lateral portions. The distance between skin surface and muscle surface was on average 4.4 mm with males having a greater distance (p < 0.001) and higher BMI being an important influencing factor for a greater distance (p < 0.001). The thickness of the DAO was on average 3.5 mm with a range of 2.8-4.8 mm and with females having thinner muscles when compared to men (p < 0.001). The most favorable injection depth was calculated to be 6.1 mm for intra-muscular product placement. CONCLUSIONS: Understanding the perioral anatomy and the influence of age, sex, and BMI will potentially allow the injectors to increase efficacy and duration of neuromodulator treatments while expertly managing adverse events.

Simplifying the injector's armamentarium: An international consensus regarding the use of gel science to differentiate hyaluronic acid fillers and guide treatment recommendations.

BACKGROUND: The Restylane portfolio of soft tissue fillers spans a wide range of indications, due in part to their complementary manufacturing technologies [non-animal stabilized hyaluronic acid (NASHA) and Optimal Balance Technology (OBT/XpresHAn)]. Using an array of products, injectors can achieve a holistic, natural looking effect for their patients. However, with a wide range of products it may be difficult to choose an optimal combination. AIM: Simplify and align global use recommendations for NASHA versus OBT products. METHODS: Two pre-meeting surveys were completed by 11 key opinion leaders with international representation, with the goal of collecting information regarding their current injection practices for various anatomical regions of the face (i.e., temporal region, forehead, tear trough, lateral zygoma, anteromedial cheek, nose, pyriform aperture, nasolabial fold, perioral area, lips, labiomental crease, marionette lines, chin, and jawline). The data collected from these surveys was subsequently discussed in a consensus group meeting involving 11 voting members and 3 nonvoting members. RESULTS: Top product recommendations were identified for each anatomical area, along with secondary and tertiary recommendations that can also be used under defined circumstances. Recommendations were provided based on a consideration of elements such as patient features (e.g., skin thickness, bone structure), the desired aesthetic outcome, experience of the injector, and the preferred injection technique. CONCLUSION: A majority consensus regarding the top NASHA versus OBT product choice for each anatomical region of the face was reached. These recommendations represent international agreement regarding the use of Restylane products.

A Practical Guide to Advanced Topical Drug Delivery Systems in Dermatology.

Dermatological diseases such as atopic dermatitis, acne, and psoriasis result in significant morbidity and decreased quality of life. The first line of treatment for such diseases is often topical medications. While topical delivery allows active drug to be delivered directly to the target site, the skin is a virtually impermeable barrier that impedes delivery of large molecules. Thus, the formulation and delivery system are integral elements of topical medications. Patients also have preferences for the properties of topical formulations and these preferences can positively or negatively impact adherence. Therefore, the choice of topical formulation is a key consideration. Recent developments in drug delivery systems have produced enhanced topical treatments that improve efficacy, safety, and patient acceptability. Awareness of the delivery system in which drugs are formulated is critical as this can have profound implications on treatment success. This paper provides an overview and clinical commentary on advances in topical delivery systems and their impact on dermatological practice.

Global Expert Opinion on Cryolipolysis Treatment Recommendations and Considerations: A Modified Delphi Study.

Background: Cryolipolysis is an increasingly popular nonsurgical fat-reduction procedure. Published treatment guidance and adverse event (AE) management protocols are limited. Objective: A modified Delphi study aimed to establish global expert consensus on the use of CoolSculpting (Allergan Aesthetics, an AbbVie Company, Irvine, CA), a noninvasive cryolipolysis treatment system. Methods: A literature search informed survey topics for an 11-expert Delphi panel. Panelists completed an online 39-question survey. An interim panel discussion, with open-ended questions and yes/no voting, informed a second survey containing 61 statements, for which panelists rated agreement using a 5-point Likert scale. Topics included treatment outcome and responder definitions, patient evaluation and selection, treatment protocols, patient satisfaction, and AEs. Results: Panelists achieved consensus on 38 final guidelines and recommendations. They reached moderate to complete consensus on 4 statements on defining responders (ie, patients with a range of visible improvement) and 6 statements on patient factors contributing to treatment outcomes (eg, how well the applicator conforms to patient body region). Panelists defined minimum numbers of treatment cycles to achieve visible clinical outcomes for 12 body regions, with moderate to complete consensus on 31 statements. They achieved a strong to complete consensus on 7 statements about patient satisfaction (eg, importance of patient expectations, visible improvement, and before-and-after photographs). Panelists defined management strategies for AEs, with moderate to complete consensus on 15 statements. Conclusions: A modified Delphi process yielded multiple guideline recommendations for cryolipolysis, providing a needed resource for the broad range of clinicians who perform this noninvasive fat-reduction procedure.

Fixed Combination Halobetasol Propionate and Tazarotene Lotion for Plaque Psoriasis.

A novel fixed combination lotion containing the super-potent corticosteroid halobetasol propionate 0.01% and retinoid tazarotene 0.045% (Duobrii™) has recently been introduced and indicated for the treatment of moderate to severe plaque psoriasis in adults. Studies have shown that there is synergy between the ingredients and that the product can be safely used intermittently for up to 1 year. Treatment success (i.e., Investigator Global Assessment [IGA] of clear/almost clear [IGA 0/1] and at least a 2-grade improvement from baseline) occurred in 58.8% of participants at some point in a 1-year clinical trial. Persistence of treatment success is common after treatment discontinuation. Most treatment-emergent adverse events are application site reactions, mild to moderate in intensity, and occur primarily during the first 12 weeks. Counselling should be considered to optimize treatment outcomes.

A Clinicoepidemiological Study of Melanoma in Young Patients (20 Years of Age or Less) in Alberta, Canada, From 1992 to 2011.

The epidemiological trends of malignant melanoma have been well described in the literature. However, there remains a paucity of population-based studies assessing melanoma epidemiology in our younger patients (20 years of age or less). Other studies indicate that melanoma incidence has risen in pediatric populations over the last several decades and that these tumors may display different clinical characteristics from those arising in adult populations. We conducted a retrospective, population-based analysis of all incident cases of melanoma occurring in young patients aged ≤20 years in Alberta from 1992 to 2011. Information, including patient age, sex, anatomical location, date of diagnosis, histological subtype (if available), level of invasion, and date of death (if applicable), was obtained from the Alberta Cancer Registry. All cases occurring during a 10-year period from 1993 to 2011 have been reviewed. A total of 71 cases were diagnosed during this time (63% female and 37% male). Age range was 0-20 years (mean of 17.5 years). Truncal melanomas made up 36% of cases, while 28% occurred on the lower limbs, 17% on the upper limbs, and 18% in the head and neck region. Average Breslow thickness was 1.97 mm; 67% of tumors were less than 1 mm thick. Unfortunately, 8 of 71 patients died from their disease. Overall, the incidence of melanoma in patients aged ≤20 years appeared to decrease in Alberta in the past 20 years; however, there has been an increase in the thickness of melanoma at diagnosis, which needs to be addressed.

Practical Guidelines for Managing Patients With Psoriasis on Biologics: An Update.

The paradigm for treating inflammatory diseases has shifted dramatically in the past 10 to 20 years with the discovery of targeted therapeutics or "biologic" agents. Patients with rheumatoid arthritis, inflammatory bowel disease, psoriatic arthritis, and psoriasis, among others, are reaping the benefits of decades of bench to bedside research, allowing them to live more productive lives with less side effects than traditional systemic therapies. Despite these advances, many physicians unfamiliar with biologics are left to care for the basic needs of these patients and may be unaware of the multisystem comorbidities associated with psoriasis and the screening, monitoring, and other special considerations required of biologics patients. This can be overwhelming to primary care physicians and inadvertently expose patients to undue risks. The aim of this review is to provide a practical approach for all health care providers caring for patients with psoriasis being treated with biologics to facilitate communication with their treating dermatologist and ultimately provide patients with more comprehensive care.

Granulomatous Tumoral Melanosis Associated With Pembrolizumab Therapy: A Mimicker of Disease Progression in Metastatic Melanoma.

Immune checkpoint inhibitor therapy has revolutionized the treatment of advanced melanoma, with these agents significantly improving survival for patients with metastatic disease. With the increasing use of these agents, the number of adverse reactions secondary to their use has also increased. Sarcoidosis and sarcoid-like reactions are one such immune checkpoint inhibitor-related adverse event. We report a case of sarcoid-like granulomatous tumoral melanosis in a patient on the programmed cell death-1 (PD-1) receptor inhibitor pembrolizumab for metastatic melanoma. This is, to our knowledge, the first reported case of a sarcoidal form of tumoral melanosis in a patient on anti-PD-1 therapy. We postulate that this reflects tumor regression in response to pembrolizumab-induced immune activation, with concomitant therapy-triggered induction of a sarcoid-like reaction. These findings and the literature review presented herein should alert clinicians and pathologists to the possibility of regressed lesions with sarcoid-like features presenting as mimickers of disease progression in patients undergoing immunotherapy for advanced melanoma.

Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison With OnabotulinumtoxinA and Placebo.

BACKGROUND: Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy. OBJECTIVE: To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS: In this Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks. RESULTS: Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups. CONCLUSION: The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).

Therapeutic approaches to cellulite.

Cellulite is a condition that affects the vast majority of women. Although it is of no danger to one's overall health, cellulite can be psychosocially debilitating. Consequently, much research has been devoted to understanding cellulite and its etiopathogenesis. With additional insights into the underlying causes of its clinical presentation, therapeutic modalities have been developed that offer hope to cellulite sufferers. This review examines evidence for topical treatments, noninvasive energy-based devices, and recently developed minimally invasive interventions that may finally provide a solution.

Laser and Light-Based Aesthetics in Men.

Men represent an important evolving segment of the cosmetic market. With the growing acceptability of cosmetic procedures along with societal and workplace pressure to maintain youthfulness, men increasingly seek the advice of aesthetic practitioners. Despite this so-called "Menaissance," there is a paucity of published literature regarding laser and light treatments of male skin. Herein the differences in male cutaneous physiology are addressed, followed by a review of light-based treatment of conditions largely unique to male skin, pseudofolliculitis barbae, and rhinophyma. Next, the publications related to laser treatment of male skin specifically are examined. We conclude with a discussion of personal observations derived from clinical experience with laser and light-based treatments in men.

A clinicopathologic review of a case series of dermatofibrosarcoma protuberans with fibrosarcomatous differentiation.

BACKGROUND: Dermatofibrosarcoma protuberans with fibrosarcomatous differentiation (DFSP-FS) is a rare variant of DFSP with a more aggressive clinical course, characterized by higher rates of local recurrence, metastasis, and death. METHODS: We conducted a clinicopathologic review of all DFSP-FS cases that occurred in Alberta, Canada, from 1997 to 2007. RESULTS: Of the 75 DFSP cases reviewed, 4 demonstrated fibrosarcomatous differentiation. Three patients were female and one was male, and the age range was 25 to 76 years. Three tumors invaded to skeletal muscle, whereas one invaded to subcutaneous tissue only. Although perineural invasion was noted in all four cases, none exhibited lymphovascular space invasion. One local recurrence developed, and two of four tumors metastasized. Metastasis was associated with tumor size, tumor necrosis, grenz zone involvement, ulceration, thickness, and tumor grade. One patient died within 5 years of diagnosis. CONCLUSION: DFSP-FS represents a more aggressive subtype of DFSP. Several features of DFSP-FS may impart a higher risk of metastasis.

Future directions in cutaneous laser surgery.

This article presents an overview of future trends in cutaneous laser therapy and technology. To enhance efficacy and specificity of treatment, new wavelengths directed at both old and new targets are on the horizon. New applications, including the use of lasers to aid in the detection of skin cancers and to enhance drug delivery, are being used and investigated. A trend toward combining different lasers and light sources to optimize results continues. Advancements in at-home devices have been made. Future applications will include waveforms beyond those in the visible light and infrared spectrum, such as microwaves, ultrasound waves, and radiofrequency.

Abbreviations for device names: a proposed methodology with specific examples.

BACKGROUND: Many devices used in dermatology lack generic names. If investigators use commercial device names, they risk the appearance of bias. Alternatively, reliance on ad-hoc names and abbreviations may confuse readers who do not recognize these. OBJECTIVE: To develop a system for assigning abbreviations to denote devices commonly used in dermatology. Secondarily, to use this system to create abbreviations for FDA-approved neurotoxins and prepackaged injectable soft-tissue augmentation materials. METHODS: The American Society for Dermatologic Surgery convened a Lexicon Task Force in March 2012. One charge of this Task Force was to develop criteria for assigning abbreviations to medical devices. A modified consensus process was used. RESULTS: Abbreviations to denote devices were to be: based on a standardized approach; transparent to the casual reader; markedly brief; and in all cases, different than the commercial names. Three-letter all caps abbreviations, some with subscripts, were assigned to denote each of the approved neurotoxins and fillers. CONCLUSION: A common system of abbreviations for medical devices in dermatology may avoid the appearance of bias while ensuring effective communication. The proposed system may be expanded to name other devices, and the ensuing abbreviations may be suitable for journal articles, continuing medical education lectures, or other academic or clinical purposes.

Epidemiology of sebaceous carcinoma in Alberta, Canada, from 1988 to 2007.

BACKGROUND: The epidemiology of sebaceous carcinoma (SC) has not previously been examined in a Canadian population. OBJECTIVE: To determine the epidemiologic trends of SC in Alberta, Canada, from 1988 to 2007. METHODS: This study was a population-based, retrospective, epidemiologic analysis of SC in Alberta over a 20-year span. RESULTS: Over the study period, the age-standardized SC incidence increased from 0.22 per 100,000 to 0.65 per 100,000. Sebaceous carcinoma is a cancer that predominantly affects the elderly (over 85% of cases were in persons 60 years or older). Interestingly, the face (37.7% of cases), not the eyelids (26.2% of cases), was the most frequently affected site overall. Gender-specific trends reflected a slight male predominance (1.4:1) and significant differences in anatomic distribution between the sexes. CONCLUSION: For unexplained reasons, there has been a threefold increase in SC incidence in Alberta over the last two decades. In addition, there are significant gender-specific differences in the anatomic distribution of SC.