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Rosacea is a chronic inflammatory skin condition of varying severity that can significantly impact patient quality of life. Intense pulsed light (IPL) is an established treatment for rosacea-associated telangiectasia, inflammation, and erythema. This study assessed whether application of a phyto-corrective mask, gel, and resveratrol antioxidant serum after IPL treatment can improve outcomes and reduce procedure-related adverse effects.In a prospective, open-label, split-face, 3-month study, 10 subjects with moderate-to-severe facial rosacea underwent IPL treatment on both sides of the face. The following were applied to the right side of the face only: phyto-corrective mask once weekly starting immediately after IPL; phyto-corrective gel twice daily; and resveratrol antioxidant treatment at night. Both sides of the face were treated with sunscreen. Subjects were assessed on Day 1, 1 and 3 months after IPL by three, independent evaluators using the 5-point Global Aesthetic Improvement Scale (GAIS). All subjects rated skin redness, hydration, and overall improvement on Day 1 and completed a patient satisfaction questionnaire at the 1- and 3-month visits.Ten women were enrolled, aged 44-72 years old, with moderate (n = 6) to severe (n = 4) rosacea. IPL was effective at reducing symptoms with rosacea classified as absent in five women and mild in five at the final 3-month visit. GAIS scores also revealed improvements on both sides of the face, but the skincare treated side showed continuous improvement over 3 months with all patients remaining at least "Improved", whereas there appeared to be a waning effect after 1 month with IPL alone. On Day 1 after IPL, all women reported less redness, improved hydration, and improved skin appearance on the right side of the face. Patient satisfaction was consistently rated higher on the right side of the face.Application of a phyto-corrective mask, gel, and resveratrol antioxidant serum may complement IPL treatment for rosacea by enhancing treatment outcomes and reducing procedure-related symptoms.

It has been well established that organ transplant recipients (OTRs) are at an increased risk of skin cancer. Studies vary on the exact degree of this risk, but it is likely somewhere between 60 and 100 times more likely that an OTR patient will develop skin cancer. The management of skin cancer burden in OTRs requires a multidisciplinary approach with the transplant team, dermatologists, and oncology. In many major hospital systems, there are dedicated transplant dermatology clinics that allow for specialized and more frequent screenings of this high-risk population. Here we discuss the pathogenesis, presentation, and treatment options used by dermatologists to prevent and treat commonly found skin cancers in this vulnerable population.

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).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.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.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).

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).To investigate the association of onabotulinumtoxinA efficacy with patient-reported psychological impacts and satisfaction in UFL.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.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.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.

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.This study sought to assess perioperative practice patterns among dermatologic surgeons with regards to antibiotic prophylaxis (AP), anticoagulation, activity restrictions, and antiseptic choice.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.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.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.

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. Level of Evidence: 5

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. Level of Evidence: 2

Background Pivotal studies of approved botulinum toxin type A (BoNTA) formulations for treatment of glabellar lines have mostly included treatment-naive participants, and the impact of prior BoNTA treatment on efficacy and safety is not well documented. Objective To evaluate whether prior BoNTA treatment affects efficacy, duration of response, and tolerability for treatment of glabellar lines. Methods Adults with moderate or severe glabellar lines treated with DaxibotulinumtoxinA for Injection (DAXI) or placebo from the randomized, double-blind SAKURA 1/2 trials and the open-label SAKURA 3 safety study were analyzed by prior BoNTA treatment status. Efficacy was evaluated using investigator and participant assessments. Results In this analysis, 609 participants (52.2% BoNTA-experienced) from the SAKURA 1/2 trials and 2,380 (38.0% BoNTA-experienced) from the SAKURA 3 study were evaluated. Proportion of participants with none or mild glabellar lines and duration of response were similar between the BoNTA-naive and BoNTA-experienced cohorts in both the DAXI and placebo groups. The incidence of adverse events was also comparable regardless of prior BoNTA treatment status. Conclusion Efficacy and tolerability were similar with DAXI and placebo regardless of prior BoNTA treatment. Assuming an appropriate washout is observed, future BoNTA trials should enroll both treatment-experienced and treatment-naive participants to reflect clinical practice.

Background ATX-101 (deoxycholic acid) significantly reduced submental fat (SMF) severity in two 24-week Phase 3 studies (REFINE-1 and REFINE-2). Objectives The aim of this study was to evaluate the durability of effect and long-term safety of ATX-101. Methods REFINE study patients who maintained ≥1-grade improvement on the Clinician-Reported SMF Rating Scale (CR-1 responders) 12 weeks after their last REFINE treatment were eligible for enrollment in this multicenter, double-blind, nontreatment, long-term, follow-up study (NCT02163902). The primary endpoint was CR-1 response at Years 1, 2, and 3. Patient-reported satisfaction, psychological impact, and adverse events were monitored. Results In total, 224 patients (ATX-101, n = 113; placebo, n = 111) were enrolled. Maintenance of CR-1 response was significantly better in the ATX-101 group than in the placebo group at Year 1 (86.4% vs 56.8%; P Conclusions Improvements in submental contour achieved with ATX-101 are maintained for 3 years in most patients. No new safety signals emerged. Level of Evidence: 2

Background Microneedling (MN) is used for the treatment of scars, amongst other indications. Although used in Asia and the Middle East for decades, related to the supposed lack of post-procedure pigmentary alterations even in darker skin types, MN only recently gained attention in the United States as an effective, well-tolerated aesthetic treatment. Materials and methods A systematic review of the Medline database was completed using search terms "microneedle" or "microneedling" or "micro needle" or "micro needling" and "scar". Included articles were written in English and discussed the use of MN for the treatment of scars in human subjects. Results Fifty-eight studies were included for review, with a total of 1845 patients treated for acne scarring, hypertrophic or keloid scars, and those resulting from surgery, trauma, varicella or smallpox. MN and its counterpart fractional radiofrequency MN (FRF-MN) were used as monotherapy or in combination with topical, surgical or systemic modalities. MN and FRF-MN treatment resulted in clinical improvement of scar appearance from baseline. No serious adverse events occurred. Conclusion MN is a well-tolerated, minimally invasive procedure that can be used for the treatment of scars with a high level of patient satisfaction. Further clinical studies are needed to develop standardized treatment protocols.

The coronavirus pandemic (COVID-19) has served as a call-to-arms in preparing practices for the next disaster whether it is another infectious disease or a flood, hurricane, earthquake, a sustained power outage, or something else. A group of predominantly core aesthetic physicians discussed the various aspects of their office procedures that warrant consideration in a proactive approach to the next pandemic/disaster-related event. This guide does not set a standard of practice but contains recommendations that may avoid some of the "lessons learned" with the COVID-19 pandemic. In this paper, the board-certified core aesthetic physicians classified these recommendations into four generalized areas: Practice Management; Supplies and Inventory; Office Staffing Considerations and Protocols; and Patient Management Strategies. Proactive strategies are provided in each of these categories that, if implemented, may alleviate the processes involved with an efficient office closure and reopening process including, in the case of COVID-19, methods to reduce the risk of transmission to doctors, staff, and patients. These strategies also include being prepared for emergency-related notifications of employees and patients; the acquisition of necessary equipment and supplies such as personal protective equipment; and the maintenance and accessibility of essential data and contact information for patients, vendors, financial advisors, and other pertinent entities.J Drugs Dermatol. 2021;20(1):10-16. doi:10.36849/JDD.5803.

BACKGROUND Laser procedures are becoming more prevalent across multiple medical specialties for a variety of indications. The plumes created by these lasers have raised concern for the dissemination of an infectious material. OBJECTIVE To review and summarize the information on viral dissemination in laser plumes available in the literature. MATERIALS AND METHODS Data Sources A systematic review was performed on English and non-English articles using the PubMed and the Cochrane databases. A manual search of bibliographies from relevant articles was also performed to collect additional studies. STUDY SELECTION Only articles in the English language with full texts available that pertained to viral particles in laser plumes were included. Data Extraction Two authors performed independent article selections using predefined inclusion and exclusion criteria. RESULTS There have been case reports of possible transmission of human papillomavirus (HPV) by inhalation of laser-produced aerosols. Multiple investigators have attempted to recreate this scenario in the laboratory to qualify this risk. Others have conducted clinical experiments to determine the presence of HPV in laser plumes. CONCLUSION The current body of the literature suggests that laser surgeons are at a risk for HPV exposure by inhalation of laser-derived aerosols. We offer best practice recommendations for laser operators.

Supplemental Digital Content is Available in the Text., BACKGROUND Real-world re-treatment intervals for botulinum toxins vary, but most subjects receive treatment less frequently than the manufacturer-recommended minimum intervals. In subjects receiving treatment with AbobotulinumtoxinA (ABO) less frequently, high levels of satisfaction and psychosocial improvements in well-being, self-confidence, and quality of life are observed. OBJECTIVE To evaluate subject satisfaction with a twice yearly re-treatment schedule. METHODS AND MATERIALS This open-label, multicenter, interventional study evaluated subject satisfaction following injections of ABO 50 U in the glabellar lines at baseline and 6 months. The primary end point was subject satisfaction at 12 months. Secondary endpoints included subject satisfaction, FACE-Q scales, and glabellar line severity scale (GLSS). RESULTS Ninety-five percent of the 120 subjects were “highly satisfied” or “satisfied” with their treatment outcomes at 12 months. FACE-Q total scores suggested that subjects were less bothered by glabellar lines and felt better about their facial appearance with each treatment versus baseline. Approximately half of subjects had ≥1-grade improvement from baseline in GLSS at 12 months. Median onset of effect was 2 days. CONCLUSION The majority of subjects (95%) were satisfied with ABO treatment every 6 months; results were supported by high subject satisfaction, long duration, rapid onset, natural-looking results, and overall psychological wellness and safety.

Background The Clinician Reported Photonumeric Cellulite Severity Scale (CR-PCSS) and Patient Reported PCSS (PR-PCSS) are newly developed tools for assessing cellulite severity. Objective To report on the reliability, validity, and ability to detect a change in cellulite severity on the buttocks of adult women with the CR-PCSS and PR-PCSS. Materials and methods Content validity of both scales was established through concept elicitation and cognitive interviews. Test-retest reliability was evaluated, and intra-rater (both scales) and inter-rater (CR-PCSS only) reliability were estimated using intraclass correlation coefficients (ICCs) for agreement and consistency. Ability to detect a change was determined using the Subject-Global Aesthetic Improvement Scale (GAIS) or Investigator-GAIS as anchors. Results For the CR-PCSS (n = 6) at baseline and Day 2, the mean interrater ICCs were ≥0.70 and mean intrarater ICCs (95% confidence interval [CI]) were ≥0.81 (0.72-0.90) for both buttocks. For the PR-PCSS (n = 99) at baseline and Day 14, the mean test-retest reliability ICCs (95% CI) were ≥0.86 (0.79-0.91) for both buttocks. A clinically meaningful change was 1.0 point on the PR-PCSS and 1.0 on the CR-PCSS. Conclusion The CR-PCSS and PR-PCSS reliably assess cellulite severity of the buttocks and can detect a clinically meaningful change after treatment for cellulite.

Supplemental Digital Content is Available in the Text., BACKGROUND DaxibotulinumtoxinA for Injection (DAXI) is botulinum toxin Type A formulated with a novel peptide excipient. Two pivotal, single-treatment, placebo-controlled trials demonstrated efficacy and safety for moderate or severe glabellar lines. OBJECTIVE To further evaluate DAXI in a large, open-label, repeat-treatment study. METHODS Subjects (n = 2,691) were enrolled from the preceding pivotal trials or de novo and received 40U DAXI. Those who received repeat treatments could be retreated when they returned to baseline on the Investigator Global Assessment–Frown Wrinkle Severity (IGA-FWS) and Patient FWS (PFWS) scales at/after 12 weeks and up to 36 weeks after treatment. RESULTS High (>96%) response rates (none or mild severity) on the IGA-FWS scale were seen after each of the 3 treatments, with peak response between Weeks 2 to 4. At Week 24, ≥32% had a response of none or mild severity. Peak response rates of ≥92% were observed at Weeks 2 to 4 on the PFWS scale. The median duration for return to moderate or severe severity was 24 weeks. The safety profile was favorable and consistent with previous trials. CONCLUSION DaxibotulinumtoxinA for Injection efficacy was highly consistent across treatment cycles. These results confirm the previously observed efficacy rates and duration of response.

Background Chlorhexidine gluconate is one of the most effective surgical preparations, but it has known potential ocular and ototoxicity. Objective To review reported cases of ocular and ototoxicity caused by chlorhexidine and summarize the clinical situations in which chlorhexidine toxicity occurred. Methods We performed a systematic review of PubMed and the Web of Science. Results Fourteen cases reported sensorineural hearing loss from chlorhexidine instilled into the ear. Of the 38 cases of ocular toxicity, 8 cases were caused by direct instillation in the eye and 17 involved periocular surgical preparation. In the remaining cases, the area prepped was less defined. Seven cases involved preparation of the face, 1 for the scalp, 2 cases were drips from distant sites, and 3 cases did not specify the means of exposure. Conclusion The vast majority of toxicity occurred in patients undergoing general anesthesia and was rarely seen in situations where surgery was performed by dermatologists. Ultimately, it should be up to the individual physician to decide whether chlorhexidine is the best choice for a particular outpatient procedure.

Primary axillary hyperhidrosis has limited noninvasive, effective, and well-tolerated treatment options.To evaluate the topical treatment of axillary hyperhidrosis with the novel anticholinergic sofpironium bromide.A phase II, multicenter, randomized, controlled, double-blinded study. Participants were randomized to 1 of 3 dosages or vehicle, with daily treatment for 42 days. Coprimary end points were the percentage of participants exhibiting ≥1-point improvement in the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) score by logistic regression, and change in HDSM-Ax as a continuous measure by analysis of covariance. Pair-wise comparisons were 1-sided with α = 0.10.At the end of therapy, 70%, 79%, 76%, and 54% of participants in the 5%, 10%, 15%, and vehicle groups exhibited ≥1-point improvement in HDSM-Ax (P .05). Least-square mean (SE) changes in HDSM-Ax were -2.02 (0.14), -2.09 (0.14), 2.10 (0.14), and -1.30 (0.14) (all P ≤ .0001). Most treatment-related adverse events were mild or moderate.Not powered to detect changes in gravimetric sweat production.Sofpironium bromide gel produced meaningful reductions in hyperhidrosis severity and had an acceptable safety profile.

Background Cutaneous surgery is associated with multiple complications including hemorrhage, surgical site infection, necrosis, and scarring As demand for dermatologic surgery rises, it is imperative that dermatologists have a comprehensive understanding of the potential surgical risks to enhance patient safety and outcomes Aims The purpose of this review is to highlight the rates, prevention, and management of common complications associated with cutaneous surgery, with a focus on scalpel-based surgeries including Mohs micrographic surgery and standard surgical excision Material and Methods Articles from PubMed are highlighted and our clinical experience is presented Results Cutaneous surgery is overall safe and associated with low rates of complications that are predominantly minor and not life-threatening Prevention and management strategies vary according to the specific complication being addressed Discussion Dermatologists should be familiar with the complications of cutaneous surgery As our knowledge of surgical complications expands, the outcomes of our patients will continue to improve

Background and objectives There is a wide diversity of opinions regarding the management of delayed inflammatory reactions (DIRs) secondary to hyaluronic acid (HA)-based fillers. The plethora of approaches has led the authors to conduct a review regarding management and treatment of DIRs as well as establish therapeutic guidelines for this purpose. Materials and methods A review of the literature was performed through databases such as PubMed using keywords including HA-fillers and complications, delayed HA filler sequelae and therapy, soft tissue and dermal filler reactions and management. Additionally, a survey comprised of questions regarding the management and treatment of DIRs was sent to 18 physicians highly experienced with soft-tissue filler injections in 10 countries. Their answers and recommendations were analyzed and debated amongst these panelists. Results Sixteen panelists favored antibiotic therapy as first -line treatment for DIRs, specifically dual antibiotic therapy consisting of a fluoroquinolone along with a tetracycline or macrolide for a period of 3-6 weeks. The majority refrained from the use of intralesional (IL) or systemic steroids except in the case of disfiguring or recalcitrant reactions. IL hyaluronidase was recommended by 13 panelists; however, some preferred a watchful waiting approach for a period of 48 hours to 2 weeks prior to IL hyaluronidase, and in cases where antibiotics did not lead to improvement. Conclusion A consensus was reached and summarized to propose a clear, easy-to-follow, stepwise algorithm for the treatment of DIRs.

Background Over the past few decades, soft tissue augmentation is ever-increasing, specifically hyaluronic acid (HA)-based filler injections. As the number of these procedures have risen, so have the adverse reactions. Delayed-type inflammatory reactions (DIRs) secondary to tissue fillers are typically classified according to the time of appearance post-procedure and have various presentations including nodules, abscesses, edema, and discoloration. Currently, the treatment of these complications varies among physicians. Objective The aim of this study was to assess the knowledge and experience of practitioners in Israel who inject HA-based tissue fillers with respect to the management of late-onset procedural complications. Materials and methods A survey regarding management and treatment of late-onset inflammatory reactions was sent to 1120 physicians and dentists in Israel who practice tissue filler injections. Results Three hundred thirty-four out of the 1120 practitioners replied to the questionnaire. The majority of respondents were dentists (group A) comprising 31% of all respondents. Group B accounted for 31% of injectors and consisted of dermatologists (19%) and plastic surgeons (12%), and group C (38%) accounted for all other practitioners; 48.2% of all injectors indicated that they have not previously encountered a DIR, whereas 11.4% responded that they have encountered more than 5 DIRs. In order to assess treatment management, we presented the injectors with a simulatory case of a woman with a late-onset complication. Most injectors referred the patient to the emergency department. When asked to establish a treatment plan, the majority of practitioners prescribed short-term oral steroids, ie, prednisone (35.3%). A limited number of patients were treated with intra-lesional hyaluronidase (31.4%) injection as only 34% of injectors kept hyaluronidase at their clinic. Conclusion The varied approach regarding the management of delayed type reactions to HA-based filler injections, reflected in our study, illustrates the existing ambivalence in the current literature regarding the management and therapy of late-onset complications.

Photodynamic therapy (PDT) can be an effective treatment for actinic keratosis (AK) as well as selected non-melanoma skin cancers (NMSCs), such as Bowen's disease and superficial basal cell carcinoma. PDT has also demonstrated effectiveness in the management of acne vulgaris. Results from controlled clinical trials have shown the safety and efficacy of PDT for these conditions with the use of different photosensitizers and a wide range of light sources. PDT has been employed effectively as monotherapy and in combination with other topicals and alternate light or laser energy therapies. This article provides expert practical guidance for the use of the newest 5-aminolevulinic acid (ALA) product (ALA 10% gel) plus red light as monotherapy for AKs, NMSC, and acne. Here, information from clinical guidelines and a summary of supporting evidence is provided for each cutaneous condition. The authors also provide detailed guidance for employing ALA 10% gel, a photosensitizer precursor, for each of these applications.

Background One of the early signs of aging is loss of jawline contour. Not all cases require surgical intervention and soft-tissue augmentation with injectable fillers may restore the profile and youthful appearance of the jawline. Objective To demonstrate the effectiveness and safety of calcium hydroxylapatite with lidocaine [CaHA (+); Radiesser (+)] to improve the contour of jawline after deep (subdermal and/or supraperiosteal) injection. Methods Healthy eligible patients with moderate or severe ratings on the Merz Jawline Assessment Scale (MJAS) were randomized 2:1 to treatment with CaHA (+) or to control. Patients in the control group remained untreated until week 12, then received delayed treatment. Touch-ups were allowed in both groups, and re-treatment was allowed in the treatment group only. Effectiveness was evaluated on the MJAS, patient and investigator Global Aesthetic Improvement Scales, and FACE-Qt questionnaires. Adverse events were recorded over a 60-week period. Results Treatment response rate (g1-point MJAS improvement) was 93/123 (75.6%) for the treatment group and 5/57 (8.8%) for the control/delayed-treatment group at week 12. The difference between response rates was statistically significant (Pl0.0001), showing superiority of treatment over control. Satisfaction with aesthetic improvement was reported by patients and treating investigators throughout the study. A total of 76/113 (67.3%) patients who responded to treatment 12 weeks after initial injection also demonstrated persistent improvement 48 weeks after initial treatment. The study demonstrated a favorable safety profile, with no reported unexpected adverse events. Conclusions CaHA (+) is a safe and effective treatment for improving the contour of the jawline. J Drugs Dermatol. 2021;20(11): 1231-1238. doi:10.36849/JDD.6442.

Background Hypochlorous acid (HOCl), a naturally occurring molecule produced by the immune system, is highly active against bacterial, viral, and fungal microorganisms. Moreover, HOCl is active against biofilm and increases oxygenation of the wound site to improve healing. Natural HOCl is unstable; through technology, it can be stabilized into an effective topical antiseptic agent. Aim This paper focuses on the use of topical stabilized HOCl in wound and scar management for pre-, peri-, and postprocedures-including its ability to reduce the occurrence hypertrophic scars and keloids. The role of the product in other skin conditions is beyond the scope of this article. Methods A panel comprising clinicians with experience in cosmetic and surgical procedures met late 2018 to discuss literature search results and their own current clinical experience regarding topical stabilized HOCl. The panel of key opinion leaders in dermatology and plastic surgery defined key insights and consensus statements on the direction of use for the product. Results Topical stabilized HOCl provides an optimal wound healing environment and, when combined with silicone, may be ideal for reducing scarring. Additionally, in contrast to chlorhexidine, HOCl, used as an antiseptic skin preparation, raises no concerns of ocular- or ototoxicity. Conclusions For wound care and scar management, topical stabilized HOCl conveys powerful microbicidal and antibiofilm properties, in addition to potency as a topical wound healing agent. It may offer physicians an alternative to other less desirable wound care measures.

Background: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. Methods: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). Results: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). Conclusions: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.

Background Laser and energy-based devices may be used for many cutaneous indications, including facial resurfacing, improving skin conditions, and reducing signs of photoaging. Currently, no consensus papers or guidelines exist concerning peri-operative agents and specifically their use for laser skin resurfacing and their potential/possible role in prevention or treatment of side effects. Aim To explore current practice using laser and energy devices, a survey was developed to identify the trends in pre- and postprocedural treatment measures. Methods The survey was sent out digitally to 300 randomly selected US dermatologist and plastic surgeon physicians practicing medical esthetics using laser and other energy devices treatment for facial rejuvenation. The survey gathered information on demographics, types of devices used in the clinic and pre-/postprocedural measures for facial laser, and other energy-based devices treatment. Results The survey was active from June 15, to July 15, 2018, and fifty-eight dermatologists and plastic surgeons completed the survey (19.3% response rate, 58/300). The results showed inconsistency in skin preparation strategies and postprocedure wound care. The majority of survey participants (55/58 [96%]) reported prophylactic oral antiviral use pre- and post-treatment; however, there was inconsistency about when to start and when to stop the use. A similar inconsistency existed in the recommended period of post-treatment sun protection before and after treatment. Conclusion The results of the survey confirmed the lack of consistency in the types and duration of pre- and postprocedural measures-emphasizing the need for evidence-based recommendations to optimize outcomes, prevent infection, enhance comfort, and reduce downtime.

Microneedling and soft-tissue filler injections have been used independently to improve acne scarring. The effectiveness of a combined approach using microneedling followed by polymethylmethacrylate (PMMA)-collagen gel has not been carefully studied.The goal of this study was to assess the effectiveness and safety of microneedling alone versus microneedling followed by injection of PMMA-collagen gel filler for correction of atrophic facial acne scars.We conducted a multicenter, open-label, randomized, prospective study on subjects with distensible atrophic acne scars in the face to determine whether microneedling with PMMA-collagen gel is a superior acne scar treatment over microneedling alone. Forty-four subjects received 3 microneedling treatments over a 12-week period followed by randomization to treatments with PMMA-collagen gel (treatment group) or no further treatment (control group).At 24 weeks, the treatment group achieved a statistically significant improvement in acne scores over microneedling alone. The improvement continued at 36 weeks. At 24 weeks, the treatment group showed a strong trend in improvement on the Physician Global Aesthetic Improvement Scale compared with microneedling alone.

Background Bleeding is an unavoidable risk of dermatologic surgery. The risk may be higher in patients taking agents that affect hemostasis. Objective The aim of this study was to provide an updated review of current anticoagulant and antiplatelet therapy available in the market and their associated risk of bleeding complications in cutaneous surgery. Materials and methods A review of PubMed and MEDLINE was performed to review the English-language medical literature. Results Many anticoagulant and antiplatelet therapies exist. Several studies recommend the continued use of antiplatelet and anticoagulant medications in the perioperative period. Combination regimens and novel oral anticoagulants may be associated with an increased risk of bleeding. Conclusion An updated understanding of antiplatelet and anticoagulant agents is critical for the surgeon. Current evidence does not support the discontinuation of antiplatelet and anticoagulant agents in the perioperative period under most circumstances. However, relevant data on novel oral anticoagulant agents are still sparse, suggesting that a precautionary approach is warranted.

Background: Hand rejuvenation has become increasingly popular, but there are few reports published on the use of hyaluronic acid gels for correction of volume deficits in the dorsal hand. Methods: This study evaluated the efficacy and safety of large-gel-particle hyaluronic acid with lidocaine, a 20-mg/ml hyaluronic acid gel with 0.3% lidocaine, compared to no treatment for the correction of volume deficits in the dorsal hand. This was a prospective, multicenter, split-hand study in 90 subjects who received treatment with product in one hand. The primary efficacy endpoint was based on a 1 point of improvement with treatment versus no treatment according to the Merz Hand Grading Scale at week 12. Other assessments included Central Independent Photographic Reviewers evaluations of hand photographs, Global Aesthetic Improvement Scale, subject satisfaction, and safety. Results: The mean injection volume was 2.1 ml at the first treatment. Subjects demonstrated significantly higher response rates with treatment compared to no treatment at week 12 (85.9 percent versus 21.2 percent) and at weeks 16, 20, and 24 (p < 0.0001). Photographic Reviewers assessments showed consistently greater improvements in the treated hands compared with the untreated hands from week 12 to week 24. Most subjects and investigators (≥92.8 percent) reported improvements in Global Aesthetic Improvement Scale score across all time points with treatment. Treatment-related adverse events were reported in seven subjects (7.9 percent). Most of these were mild, and none were serious. Conclusion: Hyaluronic acid with lidocaine is safe, effective, and well tolerated for the correction of volume deficits in the dorsal hand. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, II.

Cellulite is a common female cosmetic concern for which there are few treatment options with long-term effectiveness data. The aim of this multisite prospective registry study was to collect observational data on the real-life clinical use of a tissue stabilized-guided subcision (TS-GS) system for long-term improvement of cellulite appearance.Fifty-three subjects were enrolled and received a single treatment using the TS-GS system. Physicians treated the subjects according to their standard of care. Global Aesthetic Improvement Scale (GAIS) was completed by the patient and clinician assessing overall aesthetic improvement after 180 days. Treatment parameters, pain scores, quality of life data, and expected treatment effects and adverse events were also recorded throughout the study.The patient and physician GAIS scores at Day 180 revealed an overall improvement in 91% and 96% of patients, respectively. Quality of life and self-confidence scores also improved through 180 days. No serious adverse events were reported. Expected treatment effects were similar to those reported in the pivotal trial supporting FDA clearance.This study demonstrated significant improvement in the appearance of cellulite after a single treatment session in patients with moderate-to-severe cellulite. These results are consistent with the previously published the pivotal study data.

Background Photodynamic therapy, chemexfoliation, and ablative laser resurfacing are common practices for dermatologists, yet no formal protocols exist regarding preprocedural skin preparation. Objective To review and summarize the skin preparation protocols for photodynamic therapy, chemexfoliation, and ablative laser resurfacing available in the literature. Methods Data Sources A systematic review of English and non-English articles using the PubMed database was performed. A manual search of bibliographies from relevant articles was also performed to collect additional studies. Study Selection Only articles in the English language with full texts available that pertained to skin preparation for photodynamic therapy, chemexfoliation, and ablative laser resurfacing were included. Data Extraction Article selection was performed by one author, and relevant sources were verified by other authors using predefined inclusion and exclusion criteria. Results There is a paucity of scientific research regarding efficacy and safety of dermatologic preprocedural skin preparation agents. Only 2 studies have compared various cleansing agents for these measures. Yet, strong statements regarding the importance of degreasing are published without supportive data. Conclusion Consensus guidelines for preprocedural protocols are lacking for photodynamic therapy, chemexfoliation, and ablative laser resurfacing. Further studies are warranted to explore the efficacy and safety of various preprocedural cleansing agents.

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. Level of Evidence: 4

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.

We present a case of rapidly progressing squamous cell carcinoma in situ (SCCis) with progression to aggressive SCC. An elderly gentleman with multiple medical comorbidities presented with a left zygomatic tumor initially diagnosed as SCCis with adnexal extension on histology. After a period of approximately 10 weeks, the patient underwent Mohs micrographic surgery (MMS) with evidence that the tumor was now consistent with a well-differentiated SCC, with perineural involvement. MMS was stopped after two stages and the patient was sent to head and neck surgical oncology for further evaluation and management. It has been reported in the literature that 3ndash;5% of SCCis will progress to invasive SCC; although the inciting event to cause such progression is unknown, it is thought that mutations in key oncogenes or tumor suppressor genes such as TP53 may play a role. In addition, as many as 31% of SCCis may have a component of invasive SCC that is missed on initial histology due to sampling bias. This case reminds us that sampling bias can occur during biopsy, SCCis can rarely progress to invasive SCC, and highly aggressive SCCs may prove to be therapeutically challenging requiring a multidisciplinary approach. J Drugs Dermatol. 2020;19(11):1110-1111. doi:10.36849/JDD.2020.5184.

BACKGROUND Effacement of horizontal forehead lines (FHL) with onabotulinumtoxinA has not been investigated in prospective Phase 3 studies. OBJECTIVE To evaluate safety and efficacy of onabotulinumtoxinA treatment of FHL together with glabellar lines (GL). MATERIALS AND METHODS A 12-month, Phase 3 study randomized subjects with moderate-to-severe FHL and GL to onabotulinumtoxinA 40 U or placebo, distributed between the frontalis (20 U) and glabellar complex (20 U). After Day 180, subjects could receive up to 2 additional open-label onabotulinumtoxinA treatments. Efficacy was assessed using the Facial Wrinkle Scale (FWS) and Facial Line Outcomes questionnaire. RESULTS The intent-to-treat (ITT) population included 391 subjects, and the modified ITT (mITT) population (subjects with psychological impact) included 254 subjects. After 30 days, onabotulinumtoxinA significantly improved the investigator- and subject-assessed appearance of FHL severity by at least 2 FWS grades in 61.4% of ITT subjects versus 0% of placebo subjects (p < .0001). In the mITT population, 94.8% of onabotulinumtoxinA subjects and 1.7% of placebo subjects achieved investigator- and subject-assessed FWS ratings of none/mild (p = .0003). Patient-reported outcomes were consistent with FWS ratings. OnabotulinumtoxinA was well tolerated. CONCLUSION OnabotulinumtoxinA 40 U distributed between the frontalis and glabellar complex was safe and effective for treatment of moderate-to-severe FHL.

An approach to the reconstruction of the ear requires consideration of gross anatomy, blood supply, and size of the defect to select the repair. While skin grafts provide a convenient option for many helical and conchal defects, using posterior auricular reservoir can preserve ear contour and hide the scar for an aesthetic closure.To illustrate the versatility of the post-auricular and mastoid skin reservoir for auricular repairs after surgical removal of a cutaneous malignancy.MEDLINE, EMBASE, and Cochrane Databases were searched for all techniques using a post-auricular approach for auricular repair of surgical defects in the context of cutaneous oncology until November 2019.The most well-described techniques of pull-through, post-auricular pedicle and Banner flaps were selected for in-depth review. Illustrative cases and a summary of the spectrum of techniques from case reports are provided.Few randomized trials exist to compare the outcomes of the flaps to determine a preferred flap technique.A post-auricular approach for repair of auricular defects can provide a reasonable option for single and multi-staged closure to create an excellent aesthetic outcome while hiding the donor site. More prospective data is required to determine the overall best approach. J Drugs Dermatol. 2020;19(9):883-888. doi:10.36849/JDD.2020.5106.

Background The primary endpoint for surgical excision of skin cancer is the positive margin status. Tumor characteristics may explain much of this risk, but other important factors can include physician specialty. Objective To determine the variables affecting the success of a basal cell carcinoma (BCC) or melanoma in situ (MIS) excision. Methods/materials An 8-year, multicenter, retrospective study of 5,800 BCC or MIS excisions performed at 13 different Kaiser Permanente medical centers. The margin status was determined by searching final pathology diagnosis texts for phrases associated with positive margins. Results An incomplete excision rate was found in 23% of all specimens (BCC-22%, MIS-25%). Per specialty, the proportion of specimens with positive tumor margins was 24% for dermatology, 26% for plastic surgery, 28% for otolaryngology, and 12% for general surgery. General surgeons most often excised large tumors and tumors from truncal regions, 2 variables conferring lower odds of an incomplete excision. For non-Mohs procedures, dermatologists were no different than otolaryngologists or plastic surgeons in performing an incomplete BCC or MIS excision in all multivariate models (all p > .05). Conclusion Intrinsic tumor characteristics may influence the success of achieving tumor-free resection margins more than the specialty of the provider.