COVID-19 cases and deaths in the United States follow Taylor's law for heavy-tailed distributions with infinite variance.

The spatial and temporal patterns of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) cases and COVID-19 deaths in the United States are poorly understood. We show that variations in the cumulative reported cases and deaths by county, state, and date exemplify Taylor's law of fluctuation scaling. Specifically, on day 1 of each month from April 2020 through June 2021, each state's variance (across its counties) of cases is nearly proportional to its squared mean of cases. COVID-19 deaths behave similarly. The lower 99% of counts of cases and deaths across all counties are approximately lognormally distributed. Unexpectedly, the largest 1% of counts are approximately Pareto distributed, with a tail index that implies a finite mean and an infinite variance. We explain why the counts across the entire distribution conform to Taylor's law with exponent two using models and mathematics. The finding of infinite variance has practical consequences. Local jurisdictions (counties, states, and countries) that are planning for prevention and care of largely unvaccinated populations should anticipate the rare but extremely high counts of cases and deaths that occur in distributions with infinite variance. Jurisdictions should prepare collaborative responses across boundaries, because extremely high local counts of cases and deaths may vary beyond the resources of any local jurisdiction.

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials.

BACKGROUND: Hyperfunctional glabellar frown lines can transmit facial miscues that adversely affect emotional communication, increase perceptions of age, and diminish self-esteem. OBJECTIVE: To evaluate the efficacy of letibotulinumtoxinA in mitigating the negative psychological impact associated with moderate to severe glabellar lines and to assess subject satisfaction with treatment outcome in the BLESS phase 3 clinical trials. MATERIALS AND METHODS: Baseline and posttreatment assessments were made using validated subject-administered instruments: Modified Skindex-16 Glabellar Line Quality of Life (GL-QoL) Scale, Facial Assessment and Cosmetic Evaluation Questionnaire (FACE-Q) Appraisal of Lines Between Eyebrows Scale, FACE-Q Age Appraisal Visual Analog Scale, and FACE-Q Satisfaction with Outcome Scale. An integrated analysis using pooled BLESS data was conducted on these secondary end points. RESULTS: Among enrolled and treated subjects ( N = 1,272), 85.5% had moderate to severe psychological impact at baseline. LetibotulinumtoxinA subjects experienced significant improvements compared with placebo on all measures. Mean improvement to Week 4 for the Modified Skindex-16 GL-QoL Scale overall score was -33.84 for letibotulinumtoxinA subjects compared with -1.37 for placebo subjects ( p < .001). Attenuation of psychological burden was highly correlated with improvement in glabellar line severity ( p < .0001). CONCLUSION: LetibotulinumtoxinA significantly improved the psychosocial burden associated with glabellar lines across all trials. Treated subjects experienced improved quality of life, younger perceived age, and satisfaction with treatment outcome.

Effects of a Sheer 100% Mineral Sunscreen Moisturizer on Facial Photodamage Across Fitzpatrick Skin Types.

BACKGROUND: All skin tones need to be protected from the damaging effects of solar radiation. Although mineral sunscreens offer protection, they can have a thick, greasy feel and leave a white cast, particularly on darker skin tones. Tints offset white cast and provide visible light protection; however, patients may prefer a sheer option. Therefore, a multifunctional, sheer, 100% mineral sunscreen moisturizer (MSM) with broad-spectrum SPF 50 was developed to have positive aesthetics and deliver anti-aging and skin health benefits to all skin tones.  Methods: An IRB-approved, 12-week, open-label clinical study was conducted to investigate the efficacy and tolerability of the MSM. Thirty-nine (39) females aged 35 to 60 years with moderate-severe overall facial photodamage and representing all Fitzpatrick skin types (FST) were recruited. Participants applied the MSM to the face and neck in the morning and reapplied per US Food and Drug Administration requirements. Efficacy and tolerability grading, photography, ultrasound imaging, corneometer measurements, and questionnaires were completed at baseline and weeks 4, 8, and 12.  Results: Statistically significant progressive improvements were demonstrated from baseline to week 12. At week 12, 23.4% and 26.5% mean improvements in overall photodamage were seen for FST I-III and FST IV-VI, respectively. Favorable tolerability was shown for both the face and neck. Photography corroborated clinical grading, and ultrasound imaging indicated a trend in skin density improvement. The MSM was well-perceived.  Conclusion: The MSM is an efficacious and well-tolerated product for patients of all skin tones who desire a sheer, 100% mineral sunscreen moisturizer with anti-aging and skin health benefits. J Drugs Dermatol. 2024;23(7):538-544.  doi:10.36849/JDD.8082.

Ultraviolet Protection From a Patented Amino Acid Complex Technology.

OBJECTIVE:   This study aimed to investigate the ultraviolet (UV) protection/repair benefits of a patented Amino Acid Complex (AAComplex). METHODS: I) AAComplex was incubated with dermal fibroblasts, with/without UVA, and collagen I was measured with a GlasBoxPlus device. II) A lotion, with/without AAComplex (1%) was applied topically to skin explants, following UVA irradiation, and quantified for health-related biomarkers (TNFalpha, histamine, and MMP-1). III) A broad spectrum sunscreen with SPF 46 and a skincare serum containing AAComplex (2%) were assessed using epidermal equivalents, in the presence of UV irradiation, for effects on IL-1alpha, thymine dimers, Ki-67, filaggrin and Nrf2. RESULTS: I) Collagen I synthesis in dermal fibroblasts was significantly decreased after UVA compared to without UV. The presence of AAComplex prevented this decrease. II) UVA irradiation of skin explants increased histamine, TNFα, and MMP-1. Hydrocortisone aceponate cream significantly decreases all 3 biomarkers. AAComplex contained lotion also significantly decreased all 3 biomarkers, the no AAComplex control lotion only reduced histamine. III) With the regimen of sunscreen + AAComplex contained skincare serum, the significant reduction in IL-1alpha was observed along with a complete recovery of Ki-67 and stimulation of filaggrin and Nrf2T. No thymine dimer positive cell was observed indicating the most positive skin impact from the regiment.  Conclusion: This research using different human skin models demonstrated that AAComplex can provide protection and damage repair caused by UV, at the ingredient level also when formulated in a serum or lotion formula. Skin may be best protected from UV damage when the regimen is used.   J Drugs Dermatol. 2024;23(5):366-375. doi:10.36849/JDD.7916.

Taylor's law of fluctuation scaling for semivariances and higher moments of heavy-tailed data.

We generalize Taylor's law for the variance of light-tailed distributions to many sample statistics of heavy-tailed distributions with tail index α in (0, 1), which have infinite mean. We show that, as the sample size increases, the sample upper and lower semivariances, the sample higher moments, the skewness, and the kurtosis of a random sample from such a law increase asymptotically in direct proportion to a power of the sample mean. Specifically, the lower sample semivariance asymptotically scales in proportion to the sample mean raised to the power 2, while the upper sample semivariance asymptotically scales in proportion to the sample mean raised to the power [Formula: see text] The local upper sample semivariance (counting only observations that exceed the sample mean) asymptotically scales in proportion to the sample mean raised to the power [Formula: see text] These and additional scaling laws characterize the asymptotic behavior of commonly used measures of the risk-adjusted performance of investments, such as the Sortino ratio, the Sharpe ratio, the Omega index, the upside potential ratio, and the Farinelli-Tibiletti ratio, when returns follow a heavy-tailed nonnegative distribution. Such power-law scaling relationships are known in ecology as Taylor's law and in physics as fluctuation scaling. We find the asymptotic distribution and moments of the number of observations exceeding the sample mean. We propose estimators of α based on these scaling laws and the number of observations exceeding the sample mean and compare these estimators with some prior estimators of α.

A focused review on laser- and energy-assisted drug delivery for nail disorders.

The purpose of this review is to consolidate and summarize laser-assisted drug delivery (LADD) for nail diseases, particularly onychomycosis and psoriasis. A PubMed search was conducted in June 2023 using search terms (1) "laser assisted drug delivery" AND "nail," (2) "laser" AND "nail," and (3) "nail disorder" AND "laser treatment." References of papers were also reviewed, yielding 15 papers for this review. Fractional ablative CO2 laser (FACL) and Er:YAG laser can be used for LADD of topical medications such as amorolfine, terbinafine, and tioconazole to treat onychomycosis. A fungal culture should be performed to determine the type of dermatophyte, which will help determine which topical will be most effective. Laser settings varied between studies, but overall LADD tended to be more effective than topical treatments alone. Laser-assisted photodynamic therapy (PDT) was also found to be effective in treating onychomycosis. For psoriatic nails, LADD was used to deliver calcipotriol-betamethasone dipropionate foam, tazarotene, triamcinolone, or methotrexate into the nail. Again, LADD was found to be significantly more effective than topical treatment alone. FACL was the only laser noted for use for LADD in both diseases. Laser-assisted drug delivery for nail disease is a newer approach for onychomycosis and nail psoriasis with several benefits and drawbacks. Dermatologists should discuss the option of LADD with their patients who have recalcitrant onychomycosis or nail psoriasis.

The role of laser and energy-assisted drug delivery in the treatment of alopecia.

It has been recently established that laser treatment can be combined with topical or intralesional medications to enhance the delivery of drugs and improve overall results in a variety of different dermatological disorders. The aim of this review is to evaluate the use of laser and energy-assisted drug delivery (LEADD) for the treatment of alopecia with a specific focus on ablative fractional lasers (AFL), non-ablative fractional lasers (NAFL), and radiofrequency microneedling (RFMN). A comprehensive PubMed search was performed in December 2022 for "laser-assisted drug delivery" as well as "laser" and "alopecia." The evidence regarding LEADD for alopecia treatment is limited to two specific alopecia subtypes: alopecia areata (AA) and androgenetic alopecia (AGA)/pattern hair loss (PHL). LEADD with minoxidil and platelet-rich plasma (PRP) were evaluated for efficacy in both treatments of AA and AGA. LEADD with topical corticosteroids and intralesional methotrexate were studied for the treatment of AA, while LEADD with growth factors and stem cells were studied for the treatment of AGA. Multiple RCTs evaluated LEADD for topical corticosteroids with ablative fractional lasers for the treatment of AA. There is evidence in the literature that supports the use of topical minoxidil in combination with all devices for the treatment of AGA/PHL. All the reviewed studies show a positive treatment effect with LADD; however, some trials did not find LEADD to be superior to monotherapy or microneedling-assisted drug delivery. LEADD is a rapidly emerging treatment modality for the treatment of AGA and AA.

A Novel Approach to Shaping the Lateral Abdomen: Simultaneous Application of High-Intensity Focused Electromagnetic (HIFEM) Therapy and Synchronized Radiofrequency at the Flanks: A Multicenter MRI Study.

BACKGROUND: An accumulation of adipose tissue on the lateral abdomen (flanks) coupled with muscle deconditioning negatively affects core stability, muscular balance, and the intrinsic strength essential for maintaining optimal body mechanics and posture. This lateral fat accumulation and diminution of muscle result in an unfavorable abdominal profile and present challenges in finding appropriately fitting attire. OBJECTIVES: The aim of this study was to explore the effectiveness and safety of the simultaneous application of high-intensity focused electromagnetic (HIFEM) therapy and synchronized radiofrequency for sculpting the lateral abdomen. METHODS: All patients were scheduled to undergo four 30-minute treatments at approximately weekly intervals and then subsequent follow-up visits at 1 month and 3 months after the last treatment. The primary evaluation assessed changes in the oblique muscles, adipose tissue thickness, and cross-sectional area (CSA) by MRI performed at baseline and follow-ups. The secondary outcomes included digital photographs of the treated areas, a Subject Satisfaction Questionnaire, and a Therapy Comfort Questionnaire. Adverse events and side effects were monitored throughout the study duration. RESULTS: The muscle tissue showed a substantial increase in thickness (+27.2%) and CSA (+29.0%). The adipose tissue measurements showed a decrease of -30.5% in CSA and -28.8% in thickness. As secondary outcomes, 81.8% of patients reported feeling more toned, and 84.9% of patients found the treatment comfortable and reported less than mild pain. CONCLUSIONS: Based on the evaluation, the study suggests that the simultaneous application of HIFEM and synchronized radiofrequency is safe and effective for reducing adipose tissue and strengthening muscle in the area of the lateral abdomen.

Taylor's law for exponentially growing local populations linked by migration.

We consider the dynamics of a collection of n>1 populations in which each population has its own rate of growth or decay, fixed in continuous time, and migrants may flow from one population to another over a fixed network, at a rate, fixed over time, times the size of the sending population. This model is represented by an ordinary linear differential equation of dimension n with constant coefficients arrayed in an essentially nonnegative matrix. This paper identifies conditions on the parameters of the model (specifically, conditions on the eigenvalues and eigenvectors) under which the variance of the n population sizes at a given time is asymptotically (as time increases) proportional to a power of the mean of the population sizes at that given time. A power-law variance function is known in ecology as Taylor's Law and in physics as fluctuation scaling. Among other results, we show that Taylor's Law holds asymptotically, with variance asymptotically proportional to the mean squared, on an open dense subset of the class of models considered here.

Noninvasive Hands-free Bipolar Radiofrequency Facial Remodeling Device for the Improvement of Skin Appearance.

BACKGROUND: Aging is a multifactorial response to genetic preprogramming nuances, sun exposure, and ultraviolet radiation. Recently, there has been a paradigm shift toward minimally invasive rejuvenation. OBJECTIVE: This prospective multicenter study aims to evaluate the efficacy and safety of a novel hands-free bipolar bulk radiofrequency (RF) device in terms of improvement in skin appearance. PATIENTS AND METHODS: This multicenter prospective study enrolled subjects aged 35 to 75 years with visible signs of aging. The primary objective was to evaluate skin appearance pretreatment and at 1, 3, and 6 months after the final treatment. Each patient received 3 total treatments to the chin and cheeks using the hands-free RF device spaced 2 weeks apart. RESULTS: In total, data from 87 patients were assessed from 6 treatment sites. The average age was 54 years (range 35-75 years). Most patients were female (97%), and Fitzpatrick skin types I to V were represented. Overall, patients found the procedures to be relatively pain-free, and both patients and investigators felt they noted some improvement in their skin appearance. Histological sections demonstrated an increase in collagen or elastic fibers within the papillary dermis. CONCLUSION: This study supports the use of this novel noninvasive hands-free bipolar facial remodeling device for the improvement of skin appearance.

Two-Step Skincare Regimen Addressing Aging in Three Unique Geographic Locations: A Prospective, Multi-Center, Open-Label Study.

BACKGROUND: Extrinsic factors including solar radiation and air pollution significantly impact facial skin aging. The efficacy and tolerability of a 2-step skincare regimen consisting of a vitamin C antioxidant serum (VCAS) and a 100% mineral tinted sunscreen moisturizer (TSM) were evaluated in women with hyperpigmented and photodamaged facial skin exposed to beach, mountain, and river-traversed basin city stressors. METHODS: This was an institutional review board (IRB)-approved, multi-center, prospective, open-label study involving healthy subjects. Thirty-six females aged 35 to 60 years with Fitzpatrick Skin Types I to V and exhibiting moderate to severe hyperpigmentation and moderate photodamage were recruited. The VCAS was applied to the global face twice-daily (morning and evening), and the TSM was applied in the morning with at least 2 reapplications during daily activity for 12 weeks. Clinical grading with a validated scale, standardized photography, and a self-assessment questionnaire were performed at baseline and weeks 4, 8, and 12. RESULTS: Statistically significant improvements were shown in clinically graded efficacy parameters at weeks 4, 8, and 12. Subjects showed an average improvement of 11.7%, 14.9%, and 19.1% in overall photodamage and an average improvement of 19.5%, 23.4%, and 24.5% in clarity/brightness at weeks 4, 8, and 12, respectively. Forehead lines and cheek lines demonstrated clinically significant improvement from baseline to week 12. Both products were well-tolerated and well-perceived by subjects. CONCLUSION: The 2-step skincare regimen was well-tolerated and effective in improving extrinsic signs of facial aging induced by solar radiation and air pollution stressors after 12 weeks of use. J Drugs Dermatol. 2023;22(1):16-22. doi:10.36849/JDD.7154.

Reduction of Erythema in Moderate-Severe Rosacea by a Low Molecular Weight Heparan Sulfate Analog (HSA).

Rosacea changes are a result of an immune mediated response and the angiogenic properties of the LL-37 peptide. This peptide induces an inflammatory signal that activates the NLRP3-mediated inflammasome, triggering rosacea pathogenesis. Research findings show that LL-37 peptide is inhibited by binding to a cell surface glycosaminoglycan, heparan sulfate. Heparan Sulfate Analog (HSA) is a proprietary low molecular weight analog of heparan sulfate that has been formulated into a Dermal Repair Cream (DRC), specifically to aid in such immune mediated responses. Herein, in vitro studies using human epidermal keratinocytes showed an increase in HSA decreased LL-37 toxicity and IL-8 cytokine release. A single-center, randomized double-blind trial included 16 subjects (Fitzpatrick skin types I-IV) with a clinical diagnosis of type 1 rosacea and moderate to severe facial erythema, who were undergoing Pulsed Dye Laser (PDL) treatment. The clinical improvements of their facial erythema were assessed at baseline, 2 weeks, 4 weeks, and 8 weeks. Results revealed that low molecular weight HSA significantly improves the clinical signs of rosacea during the 8 weeks of use likely resulting from inhibition of LL-37 induced IL-8 cytokine release. These findings support the use of DRC in rosacea topical treatment regimens as it demonstrates visible skin benefits and improves tolerability of PDL therapy in a shorter duration of time as compared with PDL alone.George R, Gallo RL, Cohen JL, et al. Reduction of erythema in moderate-severe rosacea by a low molecular weight Heparan Sulfate Analog (HSA). J Drugs Dermatol. 2023;22(6):546-553. doi:10.36849/JDD.7494.

Laser-Assisted Drug Delivery in the Treatment of Scars, Rhytids, and Melasma: A Comprehensive Review of the Literature.

Although broad reviews on laser-assisted drug delivery (LADD) have been published in the past, an updated focused examination of its utility in the context of common, treatment-resistant, dermatologic conditions has not been published. This article reports a comprehensive scoping review of the potential benefits of LADD compared to laser or drug monotherapy for the treatment of 3 such conditions: scars, rhytids, and melasma. A PubMed (National Institutes of Health; Bethesda, MD) search was conducted for keywords including "laser-assisted drug delivery," "scar," "rhytid," and "melasma." Out-of-scope studies were excluded. To evaluate the efficacy of LADD for the treatment of scars, relevant articles were categorized by scar type: hypertrophic/keloid, atrophic, and hypopigmented. LADD, with both ablative and nonablative laser types, was studied in combination with corticosteroids, botulinum toxin-A (BTX-A), 5-fluorouracil, 5-aminolevulinic acid photodynamic therapy, stem cells, platelet-rich plasma, and prostaglandin analogs for the treatment of scars. Some randomized controlled trials demonstrated the efficacy of LADD, whereas others showed no significant differences in clinical outcomes but demonstrated reduced adverse effects. Regarding rhytids, laser treatment has been combined with various cosmeceuticals, including poly-L-lactic acid, topical retinaldehyde, and topical BTX-A. The studies reviewed supported the use of LADD with these drugs over monotherapy. Some studies showed that LADD was effective for the absorption of drugs such as poly-L-lactic acid and BTX-A which are often not effective topically. For melasma treatment, LADD with tranexamic acid and hydroquinone was superior in some studies, but not significantly different than monotherapy in other studies. LADD with certain drugs could be considered to treat scars, rhytids, and melasma.

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.

Postmarket Safety Surveillance of Delayed Complications for Recent FDA-Approved Hyaluronic Acid Dermal Fillers.

OBJECTIVE: To review postmarketing data for delayed (≥14 days post-treatment) adverse events (AEs) of interest (inflammatory and noninflammatory nodules, hypersensitivity, granulomas) for newer hyaluronic acid (HA) fillers FDA-approved within the last 5 years (2016-2020). METHODS: Reports from the Manufacturer and User Facility Device Experience (MAUDE) database were extracted for HAREF, HADEF, HAKYS, HAVER, HAVLR, HAVOB, HARH2, HARH3, and HARH4 from January 2016 to January 2021. Keywords from event narratives were used to identify and categorize AEs and then verified through inclusion/exclusion criteria. Percentages are based on the total combined events of interest to provide an overall perspective of the events reported during the search period. RESULTS: Of 585 MAUDE reports, there were 195 (33.3%) delayed AEs of interest. Of those, 71.8% were nodules (42.1% inflammatory and 29.7% noninflammatory), 21.5% hypersensitivity, and 6.7% granulomas. The combined total events of interest, ordered by frequency reported, were HAVLR (74.4%), HAVOB (12.3%), HADEF (5.1%), HARH4 (3.6%), HAREF (2.6%), and HARH2 (2.1%), with no reports for HARH3, HAVER, and HAKYS. CONCLUSION: Although delayed nodules and inflammatory events are rare, reports for these events were extracted from the MAUDE database from 2016 to 2020 for HAVLR, HAVOB, HADEF, HARH4, HAREF, and HARH2 (most to least frequent).

Perioperative Practices in Dermatologic Surgery.

BACKGROUND: Mohs micrographic surgery is generally safe and well tolerated. Various perioperative practices are employed with the aim of reducing adverse events; however, implementation is variable, and limited efficacy data are available. OBJECTIVE: This study sought to assess perioperative practice patterns among dermatologic surgeons with regards to antibiotic prophylaxis (AP), anticoagulation, activity restrictions, and antiseptic choice. METHODS AND MATERIALS: Two surveys were distributed by the American College of Mohs Surgery (ACMS) and the American Society for Mohs Surgery (ASMS) to their membership via email. RESULTS: One hundres seventy-seven surgeons participated, with membership from ACMS (61%), ASMS (35%), or both organizations (4%) represented. Systemic AP is prescribed preoperatively by 96% (162/168) and postoperatively by 91% (161/177) of surgeons for variable clinical indications. Therapeutic antiplatelet and anticoagulant medications are rarely held (3%-5%, 4-7/149), whereas preventative aspirin (30%, 45/149), NSAIDs (25%, 36/145), and supplements known to have an anticoagulant effect (54%, 80/149) are more commonly held. Antiseptic choice and recommended activity restrictions vary. CONCLUSION: Perioperative practices of dermatologic surgeons are variable and, where applicable, may deviate from guidelines. These findings underscore the need for standardization and updated guidelines for perioperative practices in dermatologic surgery.

High Patient Satisfaction for up to 6 Months With OnabotulinumtoxinA Treatment for Upper Facial Lines.

BACKGROUND: OnabotulinumtoxinA safety and efficacy are well established for upper facial lines (UFL), including forehead lines (FHL), glabellar lines (GL), and crow's feet lines (CFL). OBJECTIVE: To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL. MATERIALS AND METHODS: A pooled analysis of data from 4 pivotal Phase 3 trials (onabotulinumtoxinA vs placebo in FHL ± GL, FHL + GL ± CFL, CFL, and CFL + GL for ≤180 days) evaluated investigator-assessed ≥1-grade severity improvement on the Allergan Facial Wrinkle Scale at Day 30 (responders). Facial Line Outcomes (FLO-11) Questionnaire, Facial Line Satisfaction Questionnaire (FLSQ), and Subject Assessment of Satisfaction of Appearance (SASA) were used to evaluate responder appearance-related psychological impacts and satisfaction. RESULTS: OnabotulinumtoxinA patients, by primary study focus (FHL, GL, or CFL), totaled 921, 921, and 833, respectively; 786 patients received placebo. Most patients were female, White, and aged 45 to 50 years (median). Through 150 days, >42% FHL, >43% GL, and ≥32% CFL patients were onabotulinumtoxinA responders. Responders reported improvements in appearance-related psychological impacts (FLO-11) and high satisfaction (FLSQ and SASA), sustained through ≥150 days. CONCLUSION: A ≥1-grade improvement with onabotulinumtoxinA is a clinically meaningful outcome in UFL, associated with long-lasting improved patient-reported psychological impacts and high satisfaction.

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.

Multimodal Facial Aesthetic Treatment on the Appearance of Aging, Social Confidence, and Psychological Well-being: HARMONY Study.

BACKGROUND: A global approach to facial rejuvenation involves multiple treatment modalities. OBJECTIVES: The aim of this study was to evaluate the impact of multimodal facial aesthetic treatment on self-reported psychological and social outcomes. METHODS: HARMONY, a prospective, multicenter, 4-month study, enrolled patients aged 35 to 65 years to receive on-label treatment with a combination of hyaluronic fillers (VYC-20L, HYC-24L, and/or HYC-24L+), onabotulinumtoxinA, and bimatoprost. Fillers were injected on Day 1, with touch-ups performed on Day 14. OnabotulinumtoxinA was injected at Month 3 into glabellar lines and/or crow's feet lines. Patients applied bimatoprost to eyelashes once daily for 17 weeks. Mean change from baseline on FACE-Q Psychological Well-being and Social Confidence Scales, FACE-Q Aging Appearance Appraisal Scale, and FACE-Q Age Appraisal Visual Analog Scale were assessed. RESULTS: Of 100 patients treated, 93 were evaluated at 4 months posttreatment. Significant improvement vs baseline was observed on the FACE-Q Scales for Psychological Well-being (mean change, -19.9; P < 0.00001), Social Confidence (mean change, -18.2; P < 0.00001), and Aging Appearance (mean change, -28.5; P < 0.0001). On average, patients' self-assessed age was 0.1 years older than actual age at baseline and 4.5 years younger at Month 4 (P < 0.001 vs baseline). Forty-two patients experienced adverse events, all mild to moderate. CONCLUSIONS: Multimodal, full facial aesthetic treatment improves patients' self-reported psychological well-being, social confidence, aging appearance, and perceptions of chronologic age.

Ocular Complications After Laser or Light-Based Therapy-Dangers Dermatologists Should Know.

BACKGROUND: Laser and light-based technologies have been used in the medical field for over 50 years. In dermatologic and cosmetic practice, cutaneous side effects are commonly discussed; however, ocular injury may also occur. OBJECTIVE: To complete a systematic review of the current literature regarding ocular complications in the dermatologic field after laser and/or light-based therapies. MATERIALS AND METHODS: A systematic review of the Medline database was performed in August 2020 using the search terms "laser or light and ocular and complication." The inclusion criteria were articles written in English discussing ocular complications after laser or light-based therapy for dermatologic or cosmetic indications. RESULTS: A total of 36 articles were included for review. Carbon dioxide was the most frequently used laser causing ocular damage, and the most common ophthalmologic complication was temporary ectropion. Patients described visual disturbances and pain as the most common symptoms. A large proportion of articles did not report the use of appropriate eye protection at the time of injury. CONCLUSION: Although ocular injury post-laser or light-based procedures are rare, clinicians must be acutely aware of the signs and symptoms associated with eye damage. The informed consent process should thoroughly describe the possibility of ocular complications post-treatment, and medical practices should have appropriate emergency plans and protective equipment in place to decrease both patient and staff risk of injury.