Optimal Changes Seen in Patients After Treatment With Poly- l -Lactic Acid: A Retrospective Descriptive Study.

BACKGROUND: Poly- l -lactic acid (PLLA) is a biostimulator that enhances collagen production and leads to volume restoration. It became popular because of its improvement of facial wrinkles and long-lasting effect, although the specific visible changes it causes in the facial area are not fully described. OBJECTIVE: To identify and characterize the visible changes resulting from injecting PLLA into the facial area. METHODS: A list of 678 patients who underwent 2 to 3 treatments with PLLA injections in this center between 2021 and 2022 were retrieved. After 2 rounds of evaluations, 31 independent international evaluators described the 3 main changes they observed in the before-and-after images (taken approximately 7 months after the last injection session) of the 12 patients with the most significant improvement. RESULTS: A total of 1,015 descriptions were received. They were divided into categories based upon similarity. The main detected changes were better contouring and enhancement of the lateral face, a lifting effect and secondary impact on the nasolabial fold, and improvement of skin texture and skin firmness. CONCLUSION: Poly- l -lactic acid injections were judged to be effective for contouring, lifting, and improving skin texture in the facial area. Further research is needed to validate these results and create an assessment scale for PLLA injections.

Update: Cellulite Therapies and Optimizing Treatment Combinations.

Cellulite in the proximal lower extremities is a reported concern among many adult females. The unsightly appearance of cellulite leads many affected individuals to seek treatment by trained specialists. The objective of this review is to provide the reader with an update on new and innovative therapies for cellulite including various treatment combinations to maximize therapeutic outcomes, and strategies for minimizing adverse events. The availability of new technologies and the results from recent clinical trials provide additional tools and data to consider when creating treatment plans for cellulite patients. This update to previous treatment recommendations is based on the most recent developments in cellulite management including the personal experiences of the authors with an emphasis on injectable enzymes, acoustic subcision, targeted verifiable subcision, and biostimulators. Formal clinical studies are warranted to compare various treatment modalities and further investigate combination regimens.

Buttocks' Skin Laxity Severity Scale.

BACKGROUND: Clinical scales are useful to assess skin laxity in different areas of the body. OBJECTIVE: To elaborate and validate a photonumeric scale to assess buttocks skin laxity. MATERIALS AND METHODS: The Buttocks' Skin Laxity Severity Scale (SLSS) was developed based on a sample of 120 patients. The SLSS validity and reliability were assessed in 2 validation cycles, performed by 8 dermatologists assessing 50 clinical cases. Both criteria and construct validity were tested. RESULTS: The Buttocks' SLSS is composed by 5 clinical aspects of skin laxity graded from absent (0) to severe (3): buttocks ptosis, skin scalloped appearance, infragluteal fold, localized fat on the lower third of the buttocks, and linear depressed lesions. Final skin laxity classification results from the sum of each item grade multiplied by its weight and varies from 0 to 24. Overall, Kendall, weighted kappa, and intraclass correlation coefficients indicated very good reliability and consistent interrater and intrarater agreement (p < .001). Cronbach alpha of 0.82 indicates high scale reliability. The scale validity was confirmed by criteria validity tests (rs: 0.72, p < .05). CONCLUSION: Buttocks' SLSS is a reliable and valid scale to identify skin laxity severity and its different features, and it is an accurate tool for clinical research.

L-Lift Technique Using Poly-l-Lactic Acid: A Pilot Study.

BACKGROUND: Minimally invasive procedures that prevent and delay the aging process can be an alternative to more invasive surgical procedures. OBJECTIVE: To assess the efficacy and safety of L-Lift technique to improve skin firmness, facial global aesthetics, and the patient and investigator satisfaction. METHODS: Prospective, open, single-center study. Thirty participants underwent 3 treatment sessions 1 month apart and were assessed 8, 16, and 24 weeks after first injections. Assessments included the Facial Laxity Rating Scale (FLRS), Global Aesthetic Improvement Scale (GAIS), objective measurement of skin elasticity, and the Skin Distension Test. RESULTS: At Week 24, 60% of the patients had at least 1-class improvement in the FLRS for the middle face and 33% for the lower face. At Week 24, investigators considered that 90.0% of the patients improved according to the GAIS and 90.0% of the subjects considered they have improved. Skin elasticity (at Week 8 and at Week 16) and Skin Distension Test (at Week 24) assessments indicated improvement in skin firmness. Both patients and investigators were satisfied with the treatment at the study end. CONCLUSION: The technique is safe and efficacious. It may be particularly suitable for patients presenting initial signs of facial skin laxity.

Global Recommendations on COVID-19 Vaccines and Soft Tissue Filler Reactions: A Survey-Based Investigation in Cooperation With the International Society for Dermatologic and Aesthetic Surgery (ISDS).

BACKGROUND: Recent reports have surfaced from the United States Food and Drug Administration hearings in December 2020 regarding the COVID-19 vaccines and study participants who developed facial and/or lip swelling after receiving the newly developed drug. Despite an incidence rate of 0.02% in the vaccine arm of the Moderna mRNA-1273 trial, concerns have been expressed about the association of adverse reactions following soft tissue filler injections and the COVID-19 vaccines. The International Society for Dermatologic and Aesthetic Surgery (ISDS) understands these concerns and has designed the following study. METHODS: A global survey was designed to capture the incidence of adverse events related to: (1) previous soft tissue filler injections, (2) soft tissue filler injections during positive testing for COVID-19, and (3) soft tissue filler injections during and after receiving any of the COVID-19 vaccines globally available. RESULTS: The information of 106 survey participants from 18 different countries was analyzed. 80.2% (n=85) never experienced any adverse reaction following their soft tissue filler injection whereas 15.1% (n=16) experienced swelling and 4.7% (n=5) experienced pain that lasted longer than two days. Of those who received at least one dose of the COVID-19 vaccine (n=78), 94.9% reported not to have experienced any adverse reaction related to their previous soft tissue filler injection, whereas 5.1% (n=4) reported to have perceived pain that lasted longer than two days. CONCLUSION: The data collected does not support the concern for an increased risk of developing adverse reactions following soft tissue filler injections associated with the COVID-19 vaccines compared to that risk associated with other previously described triggers or the default risk following soft tissue filler injections. J Drugs Dermatol. 20(4):374-378. doi:10.36849/JDD.2021.6041.

Recommendations for Dermatology Office Reopening in the Era of COVID-19.

The COVID-19 pandemic, originating in Wuhan, China, has become a major public health and economic challenge for countries around the world. As of May 08, 2020, there are over 3 million COVID-19 cases, and 250,000 COVID-19- associated deaths in 215 countries. As more data is collected, updated infection control measures are continuously released and published by government, public health authorities, and physician specialty associations. Across the globe, dermatological practices have had to limit their operations to varying degrees to facilitate disease control, but as the pandemic subsides, they will broaden their operations. In light of the uncertainty surrounding safe and effective practice of medical and aesthetic dermatology in the era of COVID-19, fourteen international experts in the field contributed to recommendations for effective infection control protocols and practice management modifications. While guidance from the World Health Organization and local public health officials comes first, these recommendations are crafted as a starting point for dermatologists worldwide to commence either reopening their doors to patients or expanding available service offerings. This can help ensure that patients receive needed care in the short term and improve long term practice viability. J Drugs Dermatol. 2020;19(7):e-1-e-9. doi:10.36849/JDD.2020.5293.

Calculating the Thickness of the Superficial Fatty Layer of the Body Using Age, Gender, and Body Mass Index

BACKGROUND: Injections of biostimulator agents are increasing in popularity as an alternative to surgical or energy-based skin tightening procedures. The present study was designed to develop a formula that helps to guide health care providers injecting biostimulators into the correct plane to enhance effectiveness and longevity by targeting precisely the superficial fascial system. METHODS: 150 Caucasian individuals (75 males and 75 females) were investigated with a balanced distribution of age (n=30 per decade: 20­29, 30­39, 40­49, 50­59, and 60­69 years) and body mass index (n=50 per group: BMI≤24.9kg/m2, BMI between 25.0 and 29.9kg/m2 BMI≥30kg/m2). The distance between skin surface and the superficial fascia was measured via ultrasound in the buccal region, premasseteric region, the lateral neck, posterior arm, abdomen, buttocks, anterior thigh, medial thigh, and posterior thigh. RESULTS: Mean thickness of the superficial fatty layer is variable between the different locations investigated with smallest values for the lateral neck of 3.71mm ± 0.55 [range, 2.00­5.00mm] and greatest values for the gluteal region with 20.52mm±10.07 [range, 6.10­38.40mm]. A formula was developed to estimate the thickness of the superficial fatty layer based on the targeted region, age, gender, and body mass index of the patient: Thickness of superficial fatty layer (mm): Region constant + (XX* BMI) - (YY*Age). CONCLUSIONS: Injections of biostimulators deeper than the calculated values might result in reduced efficacy as the superficial fascial system is not targeted and the effected collagen neogenesis does not affect the skin surface. J Drugs Dermatol. 2020;19(1):36-44. doi:10.36849/JDD.2020.4619

Validated Assessment Scales for Cellulite Dimples on the Buttocks and Thighs in Female Patients.

BACKGROUND: New treatment methods for cellulite require globally accepted scales for aesthetic research and patient evaluation. OBJECTIVE: To develop a set of grading scales for objective assessment of cellulite dimples on female buttocks and thighs and assess their reliability and validity. MATERIALS AND METHODS: Two photonumeric grading scales were created and validated for dimples in the buttocks in female patients: Cellulite Dimples-At Rest, and Cellulite Dimples-Dynamic. Sixteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. RESULTS: Overall inter-rater reliability and intra-rater reliability were both "almost perfect" (≥0.81, intraclass correlation efficient and weighted kappa) for the At Rest scale. For the Dynamic scale, inter-rater reliability and intra-rater reliability were "substantial" (0.61-0.80). There was a high correlation between the cellulite scales and body mass index, age, weight, and skin laxity assessments. CONCLUSION: Consistent outcomes between raters and by individual raters at 2 time points confirm the reliability of the cellulite dimple grading scales for buttocks and thighs in female patients and suggest they will be a valuable tool for use in research and clinical practice.

Validated Assessment Scales for Skin Laxity on the Posterior Thighs, Buttocks, Anterior Thighs, and Knees in Female Patients.

BACKGROUND: The demand for noninvasive skin-tightening body procedures is increasing. OBJECTIVE: To develop a set of grading scales for the objective assessment of skin laxity and assess their reliability and validity. MATERIALS AND METHODS: Two photonumeric grading scales were created and validated for skin laxity in female patients: Skin Laxity-Posterior Thighs/Buttocks, and Anterior Thighs/Knees. Fifteen aesthetic experts rated photographs of 50 women in 2 validation sessions. Responses were analyzed to assess inter-rater and intra-rater reliability. RESULTS: Overall inter-rater reliability according to intraclass correlation efficient (ICC) 2.1 and weighted kappa was at least "substantial" for both scales in both sessions, and "almost perfect" (≥0.81) for the Anterior Thighs and Knees scale in session 2. Intra-rater reliability was "almost perfect" for both scales (ICC 2.1) and "substantial" to "almost perfect" by weighted kappa. A correlation between the skin laxity scales and body mass index, age, weight, sun exposure, and cellulite severity was observed. CONCLUSION: The skin laxity photonumeric grading scales are valid and reliable instruments for assessing laxity on the posterior thighs and buttocks, and anterior thighs and knees. The scales will be of value for standardizing clinical evaluations and quantifying outcome measurements in research and clinical practice.

Effective and Safe Repeated Full-Face Treatments With AbobotulinumtoxinA, Hyaluronic Acid Filler, and Skin Boosting Hyaluronic Acid

Background: It is important to study full-face aesthetic combination treatments to establish well-founded individual treatment plans. Objective: To evaluate clinical outcome and perception of treatment with either abobotulinumtoxinA (ABO) or hyaluronic acid (HA) filler followed by repeated combined treatment with ABO, HA filler, and Restylane® Skinboosters (RSB). Methods & Materials: This study was conducted at four sites in Sweden, France, and Brazil and included subjects aged 35-50 years with mild/moderate nasolabial folds and moderate/severe upper facial lines. Monotherapy was ≤125 s.U ABO in at least two upper facial indications with optional touch-up or ≤1 mL HA filler in nasolabial folds/cheeks. At months 6 and 12, both cohorts received ≤125 s.U. ABO in upper facial lines with optional touch-up, ≤2 mL HA filler in nasolabial folds/cheeks (and other facial areas as applicable), and ≤1 mL RSB. Assessments included global facial aesthetic appearance and improvement, first impression, perceived age, wrinkle severity, satisfaction questionnaires, and adverse events. Results: Repeated full-face treatment with ABO, HA filler, and RSB was associated with better aesthetic outcome and higher levels of satisfaction than treatment with ABO or HA filler alone. However, even modest volumes of HA filler achieved good aesthetic outcomes and high satisfaction. Treatment of several indications was well tolerated. Conclusion: Aesthetic improvement and subject satisfaction was high and increased with each treatment. All treatments were well tolerated. These data may be used as support when establishing individual treatment plans. J Drugs Dermatol. 2019;18(7):682-689.

Efficacy, Safety, and Subject Satisfaction After AbobotulinumtoxinA Treatment of Upper Facial Lines.

BACKGROUND: Botulinum toxins are the treatment of choice for wrinkles in the upper third of the face. OBJECTIVE: The purpose of this study was to evaluate the efficacy, safety, and subject satisfaction of abobotulinumtoxinA (ABO) for treatment of upper facial lines. MATERIALS AND METHODS: Subjects aged 35 to 50 years with moderate-to-severe upper facial lines were included in this study. Subjects received a maximum of 125 s.U. ABO in at least 2 indications with optional touch-up after 2 weeks. Assessments included wrinkle severity, global aesthetic improvement, subject satisfaction, and adverse events (AEs) 1, 3, and 6 months after treatment. RESULTS: At Month 1, 100, 94, and 93% of subjects were responders in dynamic glabellar, lateral canthal, and forehead lines, respectively. All subjects were improved 1 month after treatment, and the majority of the subjects were still improved after 6 months. After treatment, most subjects were satisfied with the appearance of their face, felt better about themselves, and agreed that the treatment made them look the way they feel. Seven subjects (22%) had 8 ABO-related AEs (mild-moderate); headache was most commonly reported (9%). CONCLUSION: AbobotulinumtoxinA effectively treated upper facial lines, with high patient satisfaction. Treatment was generally well-tolerated.

Acoustic wave therapy for cellulite, body shaping and fat reduction.

BACKGROUND: Cellulite is a common aesthetic condition that affects almost every woman. OBJECTIVE: To evaluate the efficacy of acoustic wave therapy (AWT) for cellulite and body shaping. METHODS: In this open-label, single-centre trial, 30 women presenting moderate or severe cellulite underwent 12 sessions of AWT on the gluteus and back of the thighs, over six weeks. The following assessments were performed at baseline, and up to 12 weeks after treatment: Cellulite Severity Scale (CSS), body circumference measurements, subcutaneous fat thickness by magnetic resonance imaging (MRI), quality of life related by Celluqol® and a satisfaction questionnaire. RESULTS: The treatment reduced cellulite severity from baseline up to 12 weeks after the last treatment session (subjects presenting severe cellulite: 60% to 38%). The mean CSS shifted from 11.1 to 9.5 (p < 0.001). Hips circumferences reduced from 99.7 and 103.2 cm to 96.2 and 100.3 cm (respectively, p < 0.001). The average thickness of the subcutaneous fat tissue also decreased (28.3 ± 6.5 mm to 26.7 ± 6.1mm; p < 0.001). The treatment also improved quality of life. More than 90% of the subjects would undergo the treatment again and 89% were satisfied with the results. No serious adverse events were reported. CONCLUSIONS: AWT is a safe treatment to improve cellulite appearance and reduce body circumferences.

Fields of anhidrotic effects of abobotulinumtoxinA in patients with compensatory hyperhidrosis.

BACKGROUND: Botulinum toxin type A can be used to treat compensatory hyperhidrosis (CHH), which presents areas of different intensity of sweating. More information about the anhidrotic effects is needed. OBJECTIVE: To evaluate the fields of anhidrotic effects (FAEs) resulting from different doses (5 and 10 U), dilution, and depths of injection of abobotulinumtoxinA in patients with CHH. METHODS: This was a prospective, single-center, pilot study. Ten patients suffering from CHH received 20 different injections of abobotulinumtoxinA on their backs. Midline received higher doses because of more intense sweating. The diameters of the FAEs were measured at 7, 30, and 180 days after the procedure. RESULTS: Diameters of the FAEs were significantly larger at Day 30 (p < .0001) and did not significantly differ when compared with different injection depths and volumes. Points injected with 10 U exhibited significantly larger vertical diameters at 7, 30, and 180 days (p values .05, <.0001, and .043, respectively) than those injected with 5 U, but no statistical significance was observed for the horizontal diameters. CONCLUSION: Areas of more intense sweating need higher doses to present similar diameters of the FAEs. Depth and volume of injections do not play a remarkable role on the FAEs diameters in patients suffering from CHH.

Fields of muscular and anhidrotic effects of 2 botulinum toxin-A commercial preparations: a prospective, double-blind, randomized, multicenter study.

BACKGROUND: Longevity of effects and dose equivalence of different botulinum toxin type A (BoNT-A) preparations need to be better clarified because BoNT-A units are manufacturer-specific. These points are of particular importance for new brands emerging in the market. OBJECTIVE: To assess the field of muscular and anhidrotic effects of 2 commercial preparations of BoNT-A (incobotulinumtoxinA: Xeomin [XEO]; abobotulinumtoxinA: Dysport [DYS]) administered to the upper third of the face. METHODS: Patients were randomized for the side of the forehead (left or right) in which the products were administered. All were treated receiving BoNT-A injections in 10 points (5 on each side) at a dose equivalence of 1.0:2.5 U (XEO:DYS). Clinical assessments and Minor test were performed at baseline and Days 28, 84, 112, and 140. Electromyography was performed at baseline and Days 28 and 140, and ultrasound was performed only at baseline. RESULTS: Eighty patients were enrolled in 2 research centers. Xeomin and DYS presented similar results regarding fields of muscular effects. However, a larger field of anhidrotic effects was found for DYS. There was a positive correlation between the muscle thickness and electromyography results. CONCLUSION: The results of this study suggest that a lower dose equivalence between DYS and XEO could be established.

Consensus statement regarding storage and reuse of previously reconstituted neuromodulators.

BACKGROUND: Legacy recommendations suggest that vials of botulinum toxin be used within 24 hours of reconstitution and in a single patient. Current standard of care is consistent with storage after reconstitution and use of a single vial for several patients. OBJECTIVE: To develop expert consensus regarding the effectiveness and safety of storage and reuse of botulinum toxin. MATERIALS AND METHODS: The American Society for Dermatologic Surgery authorized a task force of content experts to review the literature and provide guidance. Data extraction was followed by clinical question review, a consensus Delphi process, and validation of the results by peer review. RESULTS: After 2 rounds of Delphi process, the task force concluded by unanimous consensus and with the highest level of confidence that a vial of toxin reconstituted appropriately can, for facial muscle indications, be (1) refrigerated or refrozen for at least 4 weeks before injection without significant risk for contamination or decreased effectiveness and (2) used to treat multiple patients, assuming appropriate handling. CONCLUSION: The standard of care, which allows for use of botulinum toxin more than 24 hours after reconstitution and in more than 1 patient per vial, is appropriate and consistent with the safe and effective practice of medicine.