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.

Safety and Efficacy of TGF-ß1/COX-2 Silencing Therapeutic in Adults With Cutaneous Squamous Cell Carcinoma In Situ.

This single-center, open label, dose escalation cohort study evaluated the safety and efficacy of various doses of intralesional injections of TGF-β1/COX-2 combined with histidine-lysine polypeptide (siRNA/HKP) nanoparticle silencing therapeutic in patients with cutaneous in situ squamous cell carcinoma. Twenty-five patients (mean age: 67, SD: 10 years; 52% men) with cutaneous in situ squamous cell carcinoma participated. TGF-β1/COX-2 siRNA/HKP nanoparticle therapeutic was injected weekly for up to 6 weeks based on the following dosing cohorts: 10 μg/treatment, 20 μg/treatment, 30 μg/treatment, 60 μg/treatment, and 120 μg/treatment. The primary endpoint was the proportion of subjects with complete histological clearance. Also evaluated were the incidence/severity of treatment emergent adverse events and serious adverse events and incidence/severity of Local Skin Response. Twenty-five subjects received the TGF-β1/COX-2 siRNA/HKP nanoparticle therapeutic; 19 (76%) achieved histological clearance. In the 30 μg/treatment group and 60 μg/treatment group, percent cleared was 80% and 100%, respectively. Five subjects had 7 adverse events. There were no severe or serious adverse events; none led to treatment discontinuation, study interruption, or were related to the investigational product. Local skin response was none to minimal in most subjects, with improvement observed in the 10 μg/treatment, 20 μg/treatment, 30 μg/treatment, and 60 μg/treatment cohorts. Intralesional TGF-β1/COX-2 siRNA/HKP nanoparticle therapeutic injections appear to be noninvasive, safe, and efficacious in treating cutaneous in situ squamous cell carcinoma. The recommended doses for future study of the investigational product are 30 μg/treatment and 60 μg/treatment. J Drugs Dermatol. 2022;21(5):472-477. doi:10.36849/JDD.6384.

2020 IDEOM Annual Meeting: Actinic Keratosis Stakeholders Survey Identifies Gaps in Research and Care.

This is a report of the survey results from the International Dermatology Outcome Measures (IDEOM) actinic keratosis (AK) workgroup. The purpose of the survey was to compile a list of gaps within AK care and management that require refinement. The results were discussed at the IDEOM annual meeting held virtually on October 23–24, 2020. This built a framework with which the AK workgroup, which consisted of physicians, patients, and pharmaceutical scientists, discussed at length in their breakout session at the meeting. The electronic survey was distributed to patients, pharmaceutical scientists, and leading physician experts in the field via email on September 22, 2020, with a deadline of October 2, 2020. The survey consisted of three open-ended prompts concerning key gaps and/or unmet needs in (1) the care of AKs, (2) outcome measurement of AKs in clinical trials and, (3) the measurement of AKs in clinical practice. The results were qualitative, with a response rate of 47%. Responses included reform of outcome measures for clinical trials, a methodology for evaluating the efficacy of preventative measures, and a comparison of treatments to establish a treatment protocol, among other efforts. This paper will also provide a brief overview of the current state of the AK outcome measures, emphasizing the heterogeneity of the measures and detailing the AK workgroup's future efforts to create a reliable and applicable core outcome measure set. J Drugs Dermatol. 2022;21(2):128-134. doi:10.36849/JDD.6360.

Efficacy and Safety of Letibotulinumtoxin A in the Treatment of Glabellar Lines: A Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study.

BACKGROUND: Letibotulinumtoxin A (Hugel, Inc., Chuncheon, Republic of Korea and CROMA Pharma, Leobendorf, Austria) is a newly manufactured neurotoxin derived from Clostridium botulinum strain CBFC26. OBJECTIVES: The aim of this study was to assess the efficacy and safety of letibotulinumtoxin A in reducing glabellar line severity (GLS) and to evaluate long-term safety and efficacy following repeated injections. METHODS: In this prospective, randomized, parallel-group, double-blind, multicentre, placebo-controlled Phase III clinical trial, 355 subjects with moderate to severe glabella frown lines received injections of 20 U of letibotulinumtoxin A or placebo. GLS, onset and duration of effect, time to retreatment, and adverse events were evaluated. Response to treatment was defined as a GLS score of 0 or 1 (assessed by the subject and the investigator) and an improvement at Week 4 of ≥2 points in GLS score relative to baseline. RESULTS: At 4 weeks, 78.6% of the active treatment subjects were responders based on the investigator's assessment and 68.8% based on the subject's assessment, resulting in a composite responder rate of 64.7% for the active treatment group, whereas the corresponding rate was 0.0% in the placebo group (P < 0.001). Subjects noted a substantial improvement in GL severity as early as Day 2, with the median time to onset of effect being 3 days. The mean [standard deviation] time until first retreatment for the letibotulinumtoxin A group was 127.26 [65.6] days. Letibotulinumtoxin A was well tolerated. CONCLUSIONS: Letibotulinumtoxin A demonstrates high efficacy and a convincing safety profile in the treatment of glabellar lines.

A Randomized, Double-Blind, Active- and Placebo-Controlled Trial Evaluating a Novel Topical Treatment for Keloid Scars.

Keloid and hypertrophic scars are fibroproliferative disorders resulting from abnormal wound healing in genetically susceptible individuals. Current therapies are often ineffective. Kynurenine shows promise as a topical treatment for keloids and hypertrophic scars. In this study, healthy adult male and female subjects seeking treatment for mature keloid scars were enrolled. Subjects were randomized in double-blind fashion to receive kynurenic acid 0.5% (FS2) cream (Group 1), an active onion extract comparator treatment (Group 2), or the inactive vehicle (Group 3). Each treatment was applied twice-daily. Qualitative assessments were made using the Vancouver Scar Scale (VSS), as well as the Patient and Observer Scar Assessment Scales (POSAS). Among subjects in Group 1, there was a substantial decrease in mean PGSS scores after 30 days of treatment that continued to trend downward, becoming significant versus Group 2 at days 90 and 180 (P<0.05) and versus Group 3 at day 180 (P<0.01). Based on mean VSS scores, subjects in Group 1 achieved beneficial effects that became significant versus Group 2 at day 90 (P<0.01), day 120 (P<0.05), and day 180 (P<0.001) and versus Group 3 at day 180 (P<0.05). There were no significant improvements in Groups 2 or 3. There were no adverse events or local skin reactions. The twice-daily application of FS2 Cream represents a potentially new and effective treatment for mature keloid scars. J Drugs Dermatol. 2021;20(9):964-968. doi:10.36849/JDD.6197.

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

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

A Supersaturated Oxygen Emulsion for Wound Care and Skin Rejuvenation.

Although oxygen is essential for proper wound healing, wounds are often hypoxic with diminished oxygen delivery to the healing tissue. Since oxygenation of the outer layers of skin is almost exclusively provided by the atmosphere, increasing the presence of external oxygen enhances the healing process. Hyperbaric oxygen therapy is beneficial for treating nonhealing wounds, such as diabetic ulcers, and has been used to speed post-treatment recovery following aesthetic procedures; however, it is not suitable for home use. Recently, perfluorocarbon emulsions have been developed that can absorb large amount of oxygen. Preparations containing 2% of these compounds can absorb up to seven-times more oxygen than water at 37°C. A topical perfluorocarbon emulsion consisting of perfluorodecalin, water, plant derived emulsifiers, and a preservative, has been developed for use in dermatology (Cutagenix™ & Cutavive™ Professional Skin Care Emulsion; Cutagenesis, Niwot, CO). Designed to be applied 2 to 4 times daily following skin rejuvenation procedures, this topical oxygen emulsion reduces the incidence of post-procedure complications. The application of a topical emulsion is well-suited for patient application to enhance recovery following energy-based aesthetic procedures. J Drugs Dermatol. 2020;19(3): doi:10.36849/JDD.2020.4728.

Randomized, Investigator-Blinded Study to Compare the Efficacy and Tolerance of a 650-microsecond, 1064-nm YAG Laser to a 308-nm Excimer Laser for the Treatment of Mild to Moderate Psoriasis Vulgaris

Background: Phototherapy is a safe and effective modality for the treatment of mild to moderate psoriasis. Objectives: To compare the efficacy and safety of the 650-microsecond, 1064-nm pulsed YAG laser with the excimer laser for the treatment of mild to moderate psoriasis vulgaris of the arms and legs. Methods: Eligible subjects (n=15) aged 54.3 ± 11.7 years enrolled in a randomized, investigator-blinded study. Psoriatic plaques on one side of the body were treated with the 650-microsecond laser and plaques on the other side were treated with the 308-nm excimer laser. Subjects made up to 15 visits, twice weekly, or fewer if full clearance was achieved. Efficacy and tolerance were evaluated by the mPASI scores and local skin reactions, respectively. Results: Both devices showed efficacy in treating psoriatic plaques. Differences between the two devices were not significant for redness, thickness, scaliness, mPASI scores for arms and legs, and overall mPASI scores for the treated psoriatic plaques on each side of the body. The investigator-assessed scores for erosion/ulceration, vesicles, erythema, scaling, edema, and atrophy were low and identical for both sides of the body. Conclusion: The efficacy and tolerance of the 650-microsecond laser is equivalent to that of the excimer laser for the treatment of mild to moderate psoriasis vulgaris of the arms and legs. J Drugs Dermatol. 2020;19(2)176-183. doi:10.36849/JDD.2020.4769

A Cohort Study Using a Facial Cleansing Brush With Acne Cleansing Brush Head and a Gel Cleanser in Subjects With Mild-to-Moderate Acne and Acne-Prone Skin

Introduction: Acne vulgaris is a highly prevalent skin condition that can adversely affect the quality of life. Acne-predisposed skin is in a state of subclinical inflammation leading to skin barrier dysfunction. A multi-center cohort study was designed to evaluate clinical efficacy and safety of twice daily facial cleansing using an oscillatory sonic brush, acne brush head, and cleansing gel for 4 weeks. Methods: Subjects with mild-to-moderate acne and acne-prone skin used the cleansing regime after which they applied the skin care products they routinely used. Physician-assessed skin condition comparing baseline versus week 4 using the FDA/IGA scale and subject satisfaction with cleansing efficacy and handling properties of the regime were scored during the last visit. Results: Forty-six subjects completed the study. Physician-scored skin condition showed a statistically significant improvement in FDA/IGA scores and a significant reduction of inflammatory and non-inflammatory lesions comparing baseline versus 4 weeks. Thirty-five (76.0%) subjects had cleared or almost cleared. Subjects similarly assessed their skin to be improved. Conclusion: Both the physician and subject scores revealed the gentle cleansing routine using the sonic brush to be effective reducing the number of acne lesions, improving skin condition. No adverse events were reported during the study period. The cleansing regime may offer an attractive, safe option for maintenance and treatment of subjects with mild-to-moderate acne and acne-prone skin. J Drugs Dermatol. 2019;18(11):1140-1145.

Straight-Line Vector Planning for Optimal Results With Silhouette InstaLift in Minimally Invasive Tissue Repositioning for Facial Rejuvenation.

BACKGROUND: Absorbable suspension sutures for tissue repositioning represent a minimally invasive approach to facial rejuvenation. With 2015 FDA 510(k) approval of Silhouette InstaLift™ (Sinclair Pharma, Irvine, CA), a completely absorbable device comprised of 82% PLLA/18% PLGA sutures and bi-directional cones, came the challenge of developing optimal technique for achieving effective, precise, and durable tissue repositioning. Here, the authors discuss the importance of straight-line vector planning (SLVP) and positioning of the suture perpendicular to the plane to be elevated in obtaining optimal results for tissue repositioning. Both the scientific underpinnings of SLVP are presented, along with detailed discussion of technique for suture placement in the mid-face, jawline/jowls, and neck. METHODS: The authors are some of the earliest adopters of absorbable suspension sutures in the United States and have both used InstaLift™ sutures for tissue repositioning and facial recontouring in treatment of more than 500 patients and developed the principles of SLVP as a method to ensure optimal outcomes. RESULTS: Patient case studies illustrating the importance of SLVP are presented. In over 500 patients treated within the authors' practices since InstaLift approval there have been no serious adverse events and noticeable bruising has occurred in less than 5% of patients. Results of repositioning and recontouring are evident for up to 24 months. CONCLUSIONS: Absorbable suspension sutures are a highly adaptable, non-invasive device for lifting and repositioning of descended facial tissue. Outcomes are dependent upon proper technique, including SLVP. J Drugs Dermatol. 2018;17(7):786-793.

A Multi-Center, Open-Label, Prospective Study of Cannula Injection of Small-Particle Hyaluronic Acid Plus Lidocaine (SPHAL) for Lip Augmentation.

BACKGROUND: The use of blunt-tipped microcannulas for injection of hyaluronic acid (HA) filler in the lip and perioral area has gained popularity as they provide important safety-related advantages compared to traditional hypodermic needles. This study was conducted to assess the safety and effectiveness associated with the use of a blunt-tipped microcannula for lip augmentation and correction of perioral rhytids using a small-particle, hyaluronic acid gel plus lidocaine (SPHAL).

METHODS: A multi-center, open-label, prospective, study enrolled 60 subjects. Subjects reported injection-related events (IREs) for 2 weeks posttreatment via diary. Adverse events (AEs) were collected throughout the study. Secondary assessments at 4 and 12 weeks posttreatment included treating investigator- and subject-reported improvement in lip fullness using the Global Aesthetic Improvement Scale (GAIS) and investigator-assessed improvement in lip fullness using the Medicis Lip Fullness Scale (MLFS).

RESULTS: Sixty subjects were enrolled and treated with a mean total volume (ie, both lips and optional perioral rhytids) of 2.2 mL. Treatment-emergent adverse events (TEAEs) reported and assessed as related to the product and/or injection procedure included injection site swelling (13.3%), injection site bruising (6.7%), and injection site pain (1.7%). These were typically mild and transient in nature. No serious AEs (SAEs) were reported. Following treatment, clinically significant improvement using the GAIS and MLFS was demonstrated throughout the study (GAIS improvement at week 12 for both lips: investigator-reported, 98.0%; subject-reported, 84.3%; MLFS improvement at week 12: investigator-reported, 96.1%).

CONCLUSION: SPHAL was well tolerated and effective following injection with a blunt-tipped microcannula. No unanticipated safety concerns were identified in the study population.

J Drugs Dermatol. 2018;17(1):10-16.

Expert Consensus on Achieving Optimal Outcomes With Absorbable Suspension Suture Technology for Tissue Repositioning and Facial Recontouring.

A complete approach to facial rejuvenation includes restoration of the skin's surface, relaxation of muscles that contribute to hyperkinetic movement, revolumization, and repositioning/recontouring of descended tissues and fat pads. After receiving 510(k) clearance from the US Food and Drug Administration (FDA) in 2015, the Silhouette InstaLift™ absorbable suspension suture became the only available non-surgical technique for repositioning of facial tissue. In January 2017, a consensus paper presented a review of the literature on the efficacy and safety of absorbable suspension sutures and provided information on treatment procedures. Since that time, the clinical experience of the authors has further shaped their treatment practices, highlighting the need for additional guidelines to support an optimal treatment approach. This update will expand upon the 2017 consensus paper on the safety and efficacy of absorbable suspension sutures and provide guidance for obtaining consistently high patient satisfaction with the procedure. Recommendations are based on the extensive clinical experience of expert physicians with absorbable suspension sutures over the past 2.5 years. Here, the authors provide guidance on full face assessment and treatment to support maximum benefit and provide patient selection and procedural recommendations. In addition, the authors stress the benefits of the dual mechanisms of action within the absorbable suspension suture: the immediate lift and volumizing over time that together lead to the outcome of recontouring. J Drugs Dermatol. 2018;17(6):647-655.

The Use of Botulinum Neurotoxin Type A in Aesthetics: Key Clinical Postulates.

BACKGROUND: The most common aesthetic procedure performed worldwide is the injection of botulinum neurotoxin Type A (BoNT-A). Aesthetic providers must fully comprehend the objective scientific data, theoretical mechanisms of action, and differences between brands of BoNT-A. OBJECTIVE: To determine and review the relevant clinical postulates for the use of botulinum toxin in aesthetics. MATERIALS AND METHODS: The BoNT-A clinical postulates presented here discuss how each brand of BoNT-A acts identically, how the molecular potency may vary between the different products, how patient age, gender, genetics, and muscle mass cause variation in toxin receptor number and density, and how both practitioner and patient can affect toxin distribution. RESULTS: A total of 8 clinical postulates have been identified that are key to understanding the use of botulinum toxin in aesthetics and to obtaining the best clinical results. CONCLUSION: All of these factors affect the potential efficacy of the injected toxin and hence the aesthetic results obtained.

Expert Consensus on Absorbable Advanced Suspension Technology for Facial Tissue Repositioning and Volume Enhancement.

BACKGROUND: Signs of facial aging include wrinkles, loss of subcutaneous volume, decreased tone, texture, and sagging of the skin. The objective of this review is to determine whether facial suspension absorbable sutures are a safe and effective modality for facial rejuvenation.

METHOD: A group of US plastic surgeons and dermatologists who practice medical aesthetics convened to review evidence obtained from literature searches and to reach a consensus on clinical practice guidelines for the use of facial absorbable suspension sutures.

RESULTS: Currently, there are different types of lifting sutures available. Absorbable, facial suspension sutures allow for superior repositioning of tissue along a vector line together with the added benefit of volumization of the area. These benefits are for patients who have moderate facial aging and require treatment beyond the use of injectable products only.

CONCLUSIONS: Treatment with absorbable facial suspension sutures, when performed properly, is associated with minor and infrequent complications and offers a beneficial clinical alternative to traditional facial rejuvenation techniques.

J Drugs Dermatol. 2017;16(7):661-666.

Use of a controlled subdermal radio frequency thermistor for treating the aging neck: Consensus recommendations.

INTRODUCTION: A new temperature-controlled device has been used as a percutaneous radio frequency probe to treat lax submental and other facial areas. It has significant advantages over other esthetic devices as it provides the dual benefit of fat lipolysis and skin tightening. Our goal here is to present consensus recommendations for treating the aging neck. METHODS: A panel of 11 expert physicians convened in Dallas, Texas, on October 15, 2016 to arrive at a consensus on the best current practice for submental skin tightening and contour improvement. Prior to the meeting, a comprehensive review of the literature was performed and a survey was sent to esthetic dermatologists and plastic surgeons who were queried about various aspects of neck rejuvenation. RESULTS: The literature search revealed 10 different technologies for neck rejuvenation evaluated in double-blind (n = 2) and single-blind (n = 1) clinical trials and other clinical evaluations (n = 21). The survey was sent via an email to 1248 individuals and was completed by 92 respondents. Review of the data and discussion by meeting attendees generated eight consensus recommendations. DISCUSSION: Subdermal monopolar radio frequency represents an effective means for disrupting fat volume and skin tightening of the face, neck, and jawline. For suitable patients, this treatment can be used to achieve significant esthetic improvements.

Photobiomodulation with non-thermal lasers: Mechanisms of action and therapeutic uses in dermatology and aesthetic medicine.

BACKGROUND: Non-thermal laser therapy in dermatology, is a growing field in medical technology by which therapeutic effects are achieved by exposing tissues to specific wavelengths of light. OBJECTIVES: The purpose of this review was to gain a better understanding of the science behind non-thermal laser and the evidence supporting its use in dermatology. METHODS: A group of dermatologists and surgeons recently convened to review the evidence supporting the use of non-thermal laser for body sculpting, improving the appearance of cellulite, and treating onychomycosis. RESULTS: The use of non-thermal laser for body sculpting is supported by three randomized, double-blind, sham-controlled studies (N = 161), one prospective open-label study (N = 54), and two retrospective studies (N = 775). Non-thermal laser application for improving the appearance of cellulite is supported by one randomized, double-blind, sham-controlled study (N = 38). The use of non-thermal laser for the treatment of onychomycosis is supported by an analysis of three non-randomized, open-label studies demonstrating clinical improvement of nails (N = 292). CONCLUSIONS: Non-thermal laser is steadily moving into mainstream medical practice, such as dermatology. Although present studies have demonstrated the safety and efficacy of non-thermal laser for body sculpting, cellulite reduction and onychomycosis treatment, studies demonstrating the efficacy of non-thermal laser as a stand-alone procedure are still inadequate.

Expert Consensus on Cosmetic Outcomes After Treatment of Actinic Keratosis.

Dermatologists treat actinic keratosis (AK) primarily because these lesions have the potential to progress to invasive squamous cell carcinoma. Patients, on the other hand, generally seek treatment to remove the lesions and achieve an improved appearance of their skin following treatment. In selecting a treatment option for AK, dermatologists should consider post-treatment cosmesis, because cosmetic outcomes differ across AK treatments. To obtain expert opinion on the cosmetic sequelae related to chronically photodamaged skin and the treatment of AK, an expert panel meeting among dermatologists was conducted in February 2016. These experts reviewed current treatment options for photodamage, including AK, and discussed the relative merits of the various cosmetic assessments commonly used by investigators and patients in both clinical trial and dermatology practice settings. A main goal of the expert panel meeting was to propose assessment tools that could be specifically designed to characterize cosmesis results after treatment of AK. The panel agreed that existing tools for measurement of cosmetic outcomes following treatment of photodamage could also be used to evaluate cosmesis after treatment of AK. Digital photography is probably the best method used for this, with validation by other technologies. Better measurement tools specifically for assessing cosmesis after AK treatment are needed. Once they are developed and validated, regulatory agencies should be educated about the importance of including cosmetic outcomes as a component of product labeling.

J Drugs Dermatol. 2017;16(3):260-265.

Key Parameters for the Use of AbobotulinumtoxinA in Aesthetics: Onset and Duration.

Time to onset of response and duration of response are key measures of botulinum toxin efficacy that have a considerable influence on patient satisfaction with aesthetic treatment. However, there is no overall accepted definition of efficacy for aesthetic uses of botulinumtoxinA (BoNT-A). Mechanical methods of assessment do not lend themselves to clinical practice and clinicians rely instead on assessment scales such as the Frontalis Activity Measurement Standard, Frontalis Rating Scale, Wrinkle Severity Scale, and Subject Global Assessment Scale, but not all of these have been fully validated. Onset of activity is typically seen within 5 days of injection, but has also been recorded within 12 hours with abobotulinumtoxinA. Duration of effect is more variable, and is influenced by parameters such as muscle mass (including the effects of age and sex) and type of product used. Even when larger muscles are treated with higher doses of BoNT-A, the duration of effect is still shorter than that for smaller muscles. Muscle injection technique, including dilution of the toxin, the volume of solution injected, and the positioning of the injections, can also have an important influence on onset and duration of activity. Comparison of the efficacy of different forms of BoNT-A must be made with the full understanding that the dosing units are not equivalent. Range of equivalence studies for abobotulinumtoxinA (Azzalure; Ipsen Limited, Slough UK/Galderma, Lausanne CH/Dysport, Ipsen Biopharm Limited, Wrexham UK/Galderma LP, Fort Worth, TX) and onabotulinumtoxinA (Botox; Allergan, Parsippany, NJ) have been conducted, and results indicate that the number of units of abobotulinumtoxinA needs to be approximately twice as high as that of onabotulinumtoxinA to achieve the same effect. An appreciation of the potential influence of all of the parameters that influence onset and duration of activity of BoNT-A, along with a thorough understanding of the anatomy of the face and potency of doses, are essential to tailoring treatment to individual patient needs and expectations.

Treatment of Hyaluronic Acid Filler-Induced Impending Necrosis With Hyaluronidase: Consensus Recommendations.

Injection-induced necrosis is a rare but dreaded consequence of soft tissue augmentation with filler agents. It usually occurs as a result of injection of filler directly into an artery, but can also result from compression or injury. We provide recommendations on the use of hyaluronidase when vascular compromise is suspected. Consensus recommendations were developed by thorough discussion and debate amongst the authors at a roundtable meeting on Wednesday June 18, 2014 in Las Vegas, NV as well as significant ongoing written and verbal communications amongst the authors in the months prior to journal submission. All authors are experienced tertiary care providers. A prompt diagnosis and immediate treatment with high doses of hyaluronidase (at least 200 U) are critically important. It is not felt necessary to do a skin test in cases of impending necrosis. Some experts recommend dilution with saline to increase dispersion or lidocaine to aid vasodilation. Additional hyaluronidase should be injected if improvement is not seen within 60 minutes. A warm compress also aids vasodilation, and massage has been shown to help. Some experts advocate the use of nitroglycerin paste, although this area is controversial. Introducing an oral aspirin regimen should help prevent further clot formation due to vascular compromise. In our experience, patients who are diagnosed promptly and treated within 24 hours will usually have the best outcomes.