Extension Phase of a Multi-Center, Randomized, Blinded Clinical Study Evaluating the Efficacy and Safety of a Novel Topical Product for Facial Dyschromia.

BACKGROUND: Dyschromia can be associated with increased production and/or reduced clearance of pigmentation in the skin. Multiple pathways are involved in causality. A novel topical product was recently developed, which contains actives that have been validated through in-vitro and clinical studies to counteract pigmentation related to photodamage, PIH, and melasma. This study further evaluates the safety and efficacy of this product for facial dyschromia during an additional 3-month extension period following the completion of the previous 12-week multi-center trial.  Study Design: Subjects from the previous multi-center trial with mild to severe facial dyschromia at baseline were eligible to participate in this 3-month extension study upon completion of that trial. This extension study evaluated the continued use of the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) over a 3-month period. Subjects who were previously randomized to the novel topical product continued using it and for those previously randomized to hydroquinone 4% discontinued its use. Both cohorts continued daily sunscreen use. Blinded investigators assessed subjects at follow-up visits at 16, 20, and 24 weeks. RESULTS: Twenty-six (26) subjects completed the extension phase of the pivotal trial, with 13 subjects in each of the AL and HQ-BREAK cohorts. Significant improvements were seen within the AL cohort from weeks 12 to 24 for facial dyschromia (P=0.0158) and skin tone/clarity/evenness (P=0.0067), while there were no significant improvements seen in the HQ-BREAK cohort. The HQ-BREAK cohort had more subjects who worsened with facial dyschromia and skin tone/clarity/evenness. For the mMASI, the HQ-BREAK cohort demonstrated regression at week 24 compared to week 12, while the AL cohort instead experienced continued improvement. This difference was found to be significant (P=0.02). No study-related adverse events were reported for either cohort.  Conclusion: A novel topical product designed to counteract various steps in pigmentation pathways using PATH-3 Technology has been demonstrated to be safe and effective in treating facial dyschromia on a long-term basis. In contrast to the significant rebound experienced by subjects with HQ, the AL cohort continued to demonstrate ongoing improvement. J Drugs Dermatol. 2024;23(1):1266-1270.     doi:10.36849/JDD.7622.

A Multi-Center, Randomized, Blinded Clinical Study Evaluating the Efficacy and Safety of a Novel Topical Product for Facial Dyschromia.

BACKGROUND: Dyschromia can be caused by abnormalities in the increased production and/or reduced clearance of pigmentation in the skin. Causes of hyperpigmentation include excessive sun exposure, medications, hormones, post-inflammatory hyperpigmentation (PIH), and medical disorders, such as melasma. A novel topical product was recently developed, which contains actives that have been validated through in vitro studies to counteract various steps in the pigmentation pathways, including photodamage, PIH, and melasma. This study evaluates the safety and efficacy of this product for facial dyschromia. STUDY DESIGN: Subjects with mild to severe facial dyschromia were enrolled to receive either the novel topical product with PATH-3 Technology (Alastin Skincare, Carlsbad, CA) or hydroquinone 4% topical to apply twice daily. Both cohorts received cleanser, sunscreen, and moisturizer. Follow-up occurred at weeks 4, 8, and 12. Blinded investigators used the modified Melasma Area Severity Index (mMASI) and modified Griffiths scales at baseline and final follow-up. Tolerability assessments and subject questionnaires were completed. RESULTS: Forty-three subjects were enrolled and randomized to either the novel topical product (n=22) or hydroquinone 4% (n=21) cohort. At week 12 follow-up, subjects using the novel topical product had significant improvements in mMASI scores for the right cheek (P=0.0097), left cheek (P=0.0123), combined cheeks (P=0.0019), and total facial area (P=0.0046). In contrast, subjects using hydroquinone 4% had no significant improvements in any of these areas. Although both cohorts demonstrated improvements in dyschromia and skin tone, the novel topical product also offered significant improvements in skin radiance (P=0.0015) and skin texture (P=0.0058), which the hydroquinone 4% cohort did not demonstrate. The hydroquinone 4% cohort experienced 5 adverse events, while there were no adverse events associated with the novel topical product. Subjects in the hydroquinone 4% cohort also more frequently experienced burning/stinging, tingling, itching, erythema, and dryness. CONCLUSION: A novel topical product with PATH-3 Technology, designed to counteract various steps in pigmentation pathways, has been demonstrated to be safe and effective in treating facial dyschromia. CITATION: Wang JV, Fabi SG, Mraz Robinson D, et al. A multi-center, randomized, blinded clinical study evaluating the efficacy and safety of a novel topical product for facial dyschromia. J Drugs Dermatol. 2023;22(4):333-338. doi:10.36849/JDD.7340.

A Multi-Center Evaluation of Restorative Eye Treatment and INhance With Trihex Technology to Improve Aesthetic Outcomes When Used Pre- and Post-Blepharoplasty.

Background: Restorative Eye Treatment with TriHex Technology (RET) is a topical eye product with peptides and botanicals that reduce the appearance of crow's feet, under-eye bags, and dark circles. INhance with TriHex Technology (IH) is a topical product that has been clinically proven to accelerate the clearance of bruises and aid in the reduction of swelling. TriHex Technology has been shown to regenerate collagen and elastin. Objectives: Evaluate the use of RET compared to a bland moisturizer prior to blepharoplasty and the bilateral use of INhance postoperatively. Methods: Blepharoplasty patients were randomized to use either RET or a bland moisturizer, twice daily, on the designated periocular skin for 4 weeks prior to the procedure. Postoperatively, participants applied IH bilaterally, at least 4 times a day, and returned for follow-up on Days 1 or 3, 7, and 14. The removed upper-eyelid skin (13 patients) underwent independent dermatopathological evaluation. Results: Investigators noted no differences in peri-operative complications but observed faster improvement in swelling, bruising, discomfort on the treated side. 85% of participants had less edema and bruising on the RET pretreated side. Biopsy results revealed improved extracellular matrix appearance on the RET pretreated side. Participants agreed that IH alleviated their swelling and noted that their skin felt and appeared more hydrated. Conclusions: A regimen designed for eyelid surgery employing a pretreatment product component and a post treatment product appear to have a positive impact on measured outcomes in blepharoplasty patients including effects on bruising, swelling and patient comfort.

A Single Center, Prospective, Randomized, Blinded Study to Evaluate the Efficacy and Safety of a Topical Tripeptide/Hexapeptide Anhydrous Gel When Used Pre- and Post- Hybrid Fractional Laser for the Treatment of Acne Scars.

Background: Acne scarring remains a significant problem. Laser therapy has produced varying results with deeper ablative therapies occasionally associated with side effects including delayed healing, infection, scarring, erythema, acne, milia, edema and dyspigmentation. Objective: Can adjuvant topical therapy impact the healing process and outcome of patients treated with fractional laser for acne scarring? Methods and Materials: Ten patients were randomized to receive either Regenerating Skin Nectar with TriHex Technology®- RSN or a bland moisturizer. Patients underwent two laser procedures one month apart with Hybrid Fractional Laser. The topical was applied twice daily for 2 weeks prior to the first laser procedure, and through completion of the study. Seven study visits occurred over a 90-day period. Measurements were conducted in lesional and non-lesional areas - transepidermal water loss (TEWL), erythema, photography, Goodman and Baron qualitative scale, Global Aesthetic Improvement Scale and patient questionnaires - to assess functional recovery and aesthetic outcomes in the scarred areas. One patient from each cohort consented to biopsy before the procedures and 90 days after the first procedure. Results: Reduced TEWL scores in the RSN group were evident at all time points with statistically significant reductions occurring 4 days after first and second procedures indicating more efficient fluid conservation at a critical point in the healing trajectory. Erythema index demonstrated a consistent decrease in the RSN cohort over the control from day 4 through day 90 on lesional and non-lesional skin. Acne scar assessment scores improved in the RSN cohort compared with the control at all time points. Biopsy results showed early elastin regeneration in the RSN biopsy with controlled non-hypertrophic collagen formation evident. Conclusion: The use of RSN pre- and post- laser resurfacing significantly decreased postprocedural TEWL and erythema, and increased aesthetic improvement in acne scars and patient satisfaction, when compared with bland moisturizer.

Advances in Pigmentation Management: A Multipronged Approach.

BACKGROUND: Key cellular players regulating human skin pigmentation include melanocytes in the epidermis that synthesize melanin, neighboring keratinocytes that receive and distribute melanin in the upper layers, and fibroblasts in the dermis that affect overlying melanocytes and keratinocytes. In addition, endocrine factors from the blood supply (endothelial cells) and inflammation-related factors play a role. Thus, new strategies for affecting pigmentation need to consider these multiple cell lines to adequately cover various causes and disease processes associated with hyperpigmentation. METHODS: Pathophysiologic mechanisms and cellular pathways involved in melanogenesis were thoroughly reviewed with particular emphasis on the cellular interplay involved in the process. A complex system of interlinking and independent pathways was defined and described demonstrating differing pathways for altered pigmentary disorders - melasma associated with endothelial cell interactions; post inflammatory hyperpigmentation associated with keratinocyte inflammatory mediators (PGE2 in particular); and photodamage involving all 4 cell types. In vitro validation studies were then undertaken to define differing cell group gene expression profiles with selected peptides and other active agents. Melanocytic production of pigment was then tested with these agents to identify key potential players capable of limiting pigmentation. RESULTS: Hexapeptide-12 and lactoferrin (melanocytes), Hexapeptide-11 (in keratinocytes), and phosphatidylserine (endothelial cells) were identified as major inhibitors of melanogenesis based on their gene expression profiles. This was confirmed by secondary melanin production tests performed on melanocytic lines. Additional active agents were also identified as inhibitors of melanocytic production of melanin, and together, these constituents formed the basis for a novel formulation for use in pigmentary disorders. CONCLUSION: A comprehensive scientific narrative of the various facets relating to pigmentation has been presented including differing pathways affecting varied cell lines that effect pigment production. Based on this concept, actives were tested using gene expression studies as well as in vitro melanogenic model testing in different cell lines. Using this novel multi-faceted approach, we have selected and validated a series of active agents to be used in a formulation targeting the complex problem of hyperpigmentation. J Drugs Dermatol. 2022;21(11):1206-1220. doi:10.36849/JDD.7013.

Effects of a Topical Anti-aging Formulation on Skin Aging Biomarkers.

Objective: Following previous clinical trials, an antiaging product (Restorative Skin complex [RSC]; Alastin Skin Care Carlsbad, a Galderma company), was investigated for its effects on Klotho gene regulation, telomere length, and histological biopsy changes to provide a comprehensive picture of the mechanism and efficacy of its anti-aging effect. Methods: Neonatal human fibroblasts were used for telomere length studies to examine the effect of the full RSC formulation and the amino acid components Tripeptide-1 and Hexapeptide-12 (TriHex™) on these cellular aging mechanisms. In addition, RNA sequencing was conducted using human keratinocytes specifically investigating Klotho and related genes. This was supplemented by a clinical study using biopsy samples. Results: TriHex™ significantly upregulated the Klotho gene and related FGF23, FGFR1 and FOXO3B anti-aging genes. Significant telomere shortening reduction over control was demonstrated with the RSC formulation at four weeks and with TriHex™ at six weeks for all percentiles tested. Previous clinical studies demonstrated that the use of the antiaging regimen for 12 weeks produced a statistically significant improvement in scores for all evaluated parameters. Restaining of previous biopsy blocks from the clinical trial revealed positive ECM changes, stimulation of collagen, fibrillin, CD44 and elastin. Limitations: The study was limited by a relatively small numbers of patients in the clinical trial and the non-competitive nature of the trial. Conclusion: RSC anti-aging formulation and its TriHex™ components demonstrated significant reduction in telomere shortening, upregulation of Klotho and FOXO3 genes and biopsy validation of anti-aging efficacy. This new science supplements previous trials that demonstrated clinical efficacy of the formulation.

A Multicenter, Randomized, Double-Blind, Split-Body Clinical Trial Evaluating the Efficacy and Outcomes of a Topical Product Pre and Post Aesthetic Surgical Body Procedures.

Background: Skin preconditioning prior to and following procedures, has previously been demonstrated to hasten and optimize healing, and decrease the symptoms and signs associated with invasive surgery. These trials involved the use of multiple topical products. In an effort to control costs and to increase patient compliance, a single surgical product was developed, with actives aimed at decreasing swelling, bruising, induration, and internal fibrous banding. Objectives: This multi-center trial was designed to measure the efficacy of this single product in these mentioned parameters. Methods: A double-blind, randomized, split body, clinical study was undertaken in 29 patients involving 38 surgical procedures. Assessments included photography, biopsies, ultrasound imaging, and blinded investigator and participant assessments. Results: Differentiated results between test comparator sides became apparent at postop day 10-14 (as previously observed). Thus, blinded investigator and participant assessment scores demonstrated statistical significance exclusive to the test product side at postop day 10-14 for ecchymoses and then extending to skin discoloration, edema, induration and subcutaneous fibrous banding, at weeks 3, 4, 6, and 12. Ultrasound evaluation confirmed the earlier dissolution of fibrous banding on the test side in the subcutaneous tissue at the 3-6-week postop period. In addition, biopsies assessing the pre-conditioned period prior to surgery confirmed that the topical test product stimulated a remodeled extracellular matrix without comparative changes on the opposite side. Conclusions: A single peri-surgical product designed for the use with invasive surgery produced significant differences in ecchymosis, skin discoloration, edema, induration and ongoing resolution of fibrous banding over many weeks. This study validation provides an additional adjunct to surgical procedures.

Multicenter evaluation of a topical hyaluronic acid serum.

BACKGROUND: A new hyaluronic acid (HA) formulation was developed based on high molecular weight (MW) compounds used on the surface of the skin while using peptides to stimulate the high MW HA production by fibroblasts and keratinocytes from within the skin layers. Detailed science has been submitted to this journal in a previous publication. This multicenter study aims to validate the science by demonstrating the safety and efficacy of the product in the clinical realm. OBJECTIVES: This study evaluated the efficacy and safety of a topical HA serum in facial skin. METHODS: An open-label clinical study was undertaken over 4 months from November 2021 to March 2022. Participants applied the topical serum twice daily and were provided a gentle cleanser and an SPF 30+ to use in the morning. Follow-up visits were conducted at weeks 2, 4, and 8. At every visit, participants were measured for hydration post 15 minutes of cleansing the skin and post 15 minutes of product application for cumulative skin hydration sensor measurements. Additional procedures included participant assessments and satisfaction, investigator assessments, biopsies, and photography. RESULTS: At each follow-up visit, there was an increase in hydration measurements compared to baseline, in both immediate scores and cumulative long-term scores. At weeks 4 and 8, there was a statistically significant increase in hydration compared to baseline and the prior visit. Participants' assessments progressively increased over 2-, 4-, and 8-week intervals with significantly favorable ratings in all measured parameters. Similarly, investigator assessment grades were statistically significant (p < 0.0001) for decreased fine lines/wrinkling, crepiness, texture, erythema, and dryness, and increased (p < 0.0001) for moisture/hydration. Histology revealed increased CD44 staining in 6 of the 7 participants biopsied, denoting increased HA stimulation. In all of the participant biopsies, H&E staining demonstrated improvement in solar elastosis. Photography revealed remarkable improvement in erythema, tone, and texture. CONCLUSIONS: The study results demonstrated that the formulation produced significant improvements in immediate and long-term hydration effects on the skin as measured by the skin hydration sensor, 'wearifi' technology, comparison of before and after biopsies, and participant and investigator assessments. This high MW HA formulation produced excellent clinical improvement in skin health and hydration.

Designing topical hyaluronic acid technology-Size does matter .

INTRODUCTION: Hyaluronic acid (HA) plays an important role in cellular and extracellular matrix (ECM) homeostasis. Recent studies demonstrate that low molecular weight (MW) HA has pro-inflammatory characteristics while high MW HA is considered anti-inflammatory and regenerative. In formulating a topical HA product, the possibility of creating a focused high MW HA technology was posed, combining external surface high MW HA constituents with active agents promoting fibroblast production of high MW in the depths of the dermis. METHODS: Human dermal fibroblasts and keratinocytes were treated with various agents, and RNA sequencing (RNA-seq) was conducted to identify genes involved in HA synthesis. HA production by fibroblasts was assessed by collecting the culture supernatant, concentrating the protein, and conducting polyacrylamide gel electrophoresis (PAGE). The gel was stained with Stains-All to identify bands relative to known HA products of different MWs. Subsequently, the supernatants were treated with hyaluronidase to confirm the bands corresponded to HA. RESULTS: The RNA-seq results revealed a variety of agents upregulated HA-related genes. However, a potent upregulation of HA synthesis gene was observed by hexapeptide-11 in the keratinocytes and a newly identified proprietary octapeptide in the fibroblasts. PAGE demonstrated not only robust production of HA by octapeptide, but significantly, the HA produced was ~2 Mega Daltons in size. Octapeptide was the most potent stimulator among the tested agents. CONCLUSION: Comprehensive in vitro testing identified a group of active agents that stimulated high MW HA production. This novel approach to HA topical application with exclusively high MW HA production should maximize hydration capacity while encouraging regenerative activity within the ECM. Multi-center trials are underway.

An Analysis of Patient-Reported Recovery Outcomes of Topical Tripeptide/Hexapeptide Formulations Utilized in a Prospective Randomized Double-Blind Split Neck and Body Study.

BACKGROUND: Physicians strive to improve the postsurgical experience and optimize patient-reported recovery outcome measures (PROMs) following elective cosmetic surgical procedures. Our previous pilot feasibility study demonstrated that twice daily postoperative topical body treatment with tripeptide and hexapeptide (TransFORM Body Treatment with TriHex Technology [TFB, Alastin Skincare, Inc., Carlsbad, CA]) reduced PROMs of swelling, induration, soft tissue fibrosis, and pain as well as improved visible and palpable skin quality. OBJECTIVES: Evaluate whether adding a tripeptide/hexapeptide anhydrous gel (Regenerating Skin Nectar with TriHex Technology [RSN, Alastin Skincare, Inc., Carlsbad, CA]) pre- and post-procedure to the existing postsurgical regimen of TFB significantly improves 6 PROMs in patients undergoing neck and body contouring cosmetic surgical procedures. METHODS: Ten female patients underwent 15 neck and body contouring procedures and were blindly randomized to 1 of 2 topical treatment protocols (1 [TFB] and 2 [RSN/TFB]) pre- and post-procedure. Patient-reported scores of 5 skin parameters (skin discoloration, ecchymosis, edema, induration, and subcutaneous fibrous banding) and pain scores using the Visual Analog Scale were collected at 8 intervals for 12 weeks post-procedure. RESULTS: The treatment side that used both topicals showed significantly reduced scores of edema, induration, and subcutaneous fibrous banding compared with the side that only used 1 topical, on days 5-7 and 10-14 (P < 0.05). All patients observed slower soft tissue recovery on the side that was treated with TFB alone and opted to break the code and use both topical treatments. CONCLUSIONS: Patients had statistically significant improved patient-reported measures of skin edema, skin induration, and subcutaneous banding on the operated side that used both topicals.

Evaluating the Efficacy, Tolerability, and Outcomes of Topical Tripeptide/Hexapeptide Formulations Before and After Liposuction of the Medial Thighs.

Regenerating Skin Nectar with TriHex Technology (RSN) has been shown clinically to promote healing and outcomes post procedures. TransFORM Body Treatment with TriHex Technology (TFB) has demonstrated clinically to improve lipid droplet dissolution and patient-reported outcomes post procedure. Histologically, both have been proven to regenerate collagen and elastin. The objective is to evaluate postprocedural recovery, histological, and gene expression changes of medial thigh liposuction in participants using RSN and TFB on one thigh in comparison with a bland moisturizer on the other. Participants were randomized to apply RSN pre and post procedure and TFB post procedure to one thigh and a bland moisturizer to the other. After topical pretreatment, participants underwent bilateral medial thigh liposuction. Assessments included induration measurements, ultrasounds, blinded investigator assessments, participant assessments, photography, and biopsies for 10 weeks post procedure. Blinded investigator assessments of induration, edema, and subcutaneous fibrous banding had less severity at weeks 1, 2, and 4 on the RSN/TFB thigh, corresponding with induration measurements. Ultrasound images showed less fluid infiltration, edema, and induration on the RSN/TFB side over the bland moisturizer at 2 weeks. Gene expression confirmed a hastened inflammatory phase converting more rapidly to the anti-inflammatory regenerative healing environment with evidence of extracellular remodeling only present on the RSN/TFB side at week 4, and histological biopsies demonstrated improved collagenesis and elastogenesis. RSN used before surgical procedures combined with RSN and TFB post procedure has demonstrated remodeling of the extracellular matrix, accelerating healing, and initiation of anti-inflammatory genes.

Prospective, Randomized, Comparative Study of the Cutaneous Effects of a Topical Body Treatment Compared to a Bland Moisturizer.

BACKGROUND: Over time human skin thins and loses elasticity; topical treatments attempt to reverse this process. OBJECTIVES: The aim of this study was to assess the efficacy of TransFORM Body Treatment (TFB) in skin rejuvenation compared to a bland moisturizer on the extensor and volar forearms. METHODS: Blinded participants were given 2 products to apply on the designated forearms with follow-up at 4, 8, and 12 weeks. Measurements included skin thickness, photography, dermatopathology, cutaneous elasticity determined by 2 different methods, and patient-reported outcomes. All were compared to baseline. RESULTS: Changes between bland moisturizer and TFB were recorded for the following parameters. (1) Roughness: extensor -0.09 mm for bland moisturizer and -0.26 mm for TFB (P = 0.174); volar 0.01 mm for bland moisturizer and -0.23 mm for TFB (P = 0.004). (2) Recoil velocity: volar -56°/sec for bland moisturizer and -24°/sec for TFB (P = 0.61); extensor -95°/sec for bland moisturizer and -63°/sec for TFB (P = 0.57). Retraction speed: volar -3.25 ms for bland moisturizer and -20.08 ms for TFB (P = 0.33); extensor -2.17 ms for bland moisturizer and -10.83 ms for TFB (P = 0.66). Histologically, TFB resulted in an increase in mucopolysaccharide content, new collagen, and number of elastin fibers in the papillary dermis. Changes in the Rao-Goldman score were also observed: volar -0.17 for bland moisturizer and -0.33 for TFB (P = 0.25); extensor -0.08 for bland moisturizer and -0.17 for TFB (P = 0.36). CONCLUSIONS: Histology showed production of new collagen and elastin. Quantification of changes in skin thickness, skin retraction speed, and skin recoil velocity showed trends that agree with the visual data.

Developing a Topical Adjunct to Injectable Procedures.

Injectable procedures have come to play an enormous part in everyday aesthetic medical practice. Whether its use is directed at volumizing with fillers, decreasing volume using enzymes, skin-tightening using multi-needle approaches, or neuromuscular blockade, the injectable route is the means of delivery in all these cases, making injectable procedures the most common aesthetic procedure performed. As with all procedures, expected and unexpected consequences may follow including bruising, swelling, discomfort, and the possibility of infection. This paper outlines the scientific process and validation of a product designed as an adjunct to injection therapy and the scientific deep dive needed to encompass both symptomatic and adjunctive purposes. On the symptomatic side, bruising, swelling, and pain were considered, while volumetric enhancement, regeneration, and anti-microbial/biofilm effects were desired outcomes from the adjunctive perspective. Utilizing peptides and active agents aimed at reducing excess residual iron and stimulating macrophage absorption of red blood cells, we were able to achieve efficient resolution of bruising. In addition, peptides were included to stimulate collagen, elastin, and hyaluronic acid in synergy with the injectable. Anti-inflammatory, antimicrobial, and antibiofilm agents were added to aid in the safety profile of the injectable. In vivo testing of bruising resolution demonstrated that at day 2/3, participants using the study product (INhance Post-Injection Serum with TriHex Technology®, Alastin Skincare, Inc. Carlsbad, CA) had 73% less bruise color intensity and statistically significant improvement over the bland moisturizer. Overall, 81% of subjects applying the study topical product had less bruising at day 2/3 compared to the bland moisturizer. J Drugs Dermatol. 2020;19(4):398-404. doi:10.36849/JDD.2020.5016.

A randomized double-blind trial evaluating the efficacy and tolerability of topical body treatment with TriHex Technology® combined with abdomen cryolipolysis or radiofrequency procedures.

BACKGROUND: Nonsurgical fat reduction procedures using cryolipolysis and radiofrequency are among the most popular noninvasive aesthetic procedures. In a previous study, TransFORM Body Treatment (TFB) with TriHex Technology® (ALASTIN® Skincare) improved the contour and reduced skin laxity following cryolipolysis of the arms. This product is formulated using a combination of peptides and other active ingredients designed to stimulate the autophagic breakdown of lipid droplets and expedite the apoptotic process after fat reduction procedures. AIMS: To assess the changes in abdominal volume after application of TFB for 12 weeks following cryolipolysis and radiofrequency procedures. METHODS: Following abdominal cryolipolysis or radiofrequency therapy, the subjects (N = 15) received TFB product and placebo and were randomly assigned to apply to the right or left sides of the abdomen for 12 weeks. Using 3-dimensional digital imaging analysis, subjects were evaluated at 4, 8, and 12 weeks posttreatment. RESULTS: Topical TFB resulted in increased volume loss, which was greater than that for placebo at weeks 4 (P = .0511), 8 (P = .0238), and 12 (P = .0078), respectively, and statistically significant at weeks 8 and 12. There were no reported adverse events. CONCLUSION: In this study, Topical application of TFB significantly increased adipose volume loss and improved clinical outcomes of nonsurgical fat reduction procedures.

Gene Expression Changes in the Skin of Patients Undergoing Medial Thigh Liposuction With Pre-Surgical and Post-Surgical Application of Topical Products.

BACKGROUND: Skin topical preconditioning before and after surgical procedures is a relatively new concept, particularly in relation to the efficient removal of tissue breakdown products. Clinical trials demonstrate improvements, such as less induration, when surgery is combined with topical product preconditioning and with usage post-surgery. OBJECTIVES: This trial aimed to assess the efficacy of such a regimen at the molecular level through gene expression studies in combination with clinical assessments. METHODS: Six women who underwent medial thigh liposuction administered either a bland moisturizer or the experimental topical products to each side of the surgical area twice daily. Biopsies were taken before any topical application, at 2 and 4 weeks after liposuction. An inflammation-related gene expression analysis was conducted to compare the different conditions. In addition, the degree of induration was assessed in a blinded manner. RESULTS: Compared with the bland moisturizer, the experimental group demonstrated a hastened immune inflammatory response moving more rapidly to an anti-inflammatory reversal at 2 weeks followed by a wound healing extracellular remodeling effect at 4 weeks. This matched the clinical picture depicting less induration with the treatment. CONCLUSIONS: For patients undergoing body procedures, a topical treatment with the Alastin induces an accelerated healing response, inducing the clearance of "waste" products and the induction of anti-inflammatory genes. Furthermore, this topical treatment stimulates extracellular matrix remodeling, which ultimately leads to less induration.

A Class of Organopolysulfides As Liquid Cathode Materials for High-Energy-Density Lithium Batteries.

Sulfur-based cathodes are promising to enable high-energy-density lithium-sulfur batteries; however, elemental sulfur as active material faces several challenges, including undesirable volume change (∼80%) when completely reduced and high dependence on liquid electrolyte wherein an electrolyte/sulfur ratio >10 µL mg-1 is required for high material utilization. These limit the attainable energy densities of these batteries. Herein, we introduce a new class of phenyl polysulfides C6H5S xC6H5 (4 ≤ x ≤ 6) as liquid cathode materials synthesized in a facile and scalable route to mitigate these setbacks. These polysulfides possess sufficiently high theoretical specific capacities, specific energies, and energy densities. Spectroscopic techniques verify their chemical composition and computation shows that the volume change when reduced is about 37%. Lithium half-cell testing shows that phenyl hexasulfide (C6H5S6C6H5) can provide a specific capacity of 650 mAh g-1 and capacity retention of 80% through 500 cycles at 1 C rate along with superlative performance up to 10 C. Furthermore, 1302 Wh kg-1 and 1720 Wh L-1 are achievable at a low electrolyte/active material ratio, i.e., 3 µL mg-1. This work adds new members to the cathode family for Li-S batteries, reduces the gap between the theoretical and practical energy densities of batteries, and provides a new direction for the development of alternative high-capacity cathode materials.

Safety and efficacy of a rapid-acting topical 4% lidocaine gel in a unique drug delivery system.

BACKGROUND: Ideally, topical anesthetics should provide rapid analgesic action without causing toxic blood levels of lidocaine or other side effects. Various formulations of lidocaine as a topical anesthetic have been tested and are currently on the market. Here, the authors report on a topical lidocaine with a novel delivery system that provides a rapid onset of action without toxic plasma els of lidocaine. OBJECTIVE: Study 1 assessed the time needed for a topical 4% lidocaine gel with a unique drug delivery system to produce optimal anesthetic effects. Study 2 assessed lidocaine plasma concentrations and assessed the time to maximal anesthetic effect. METHODS: In both studies, subjects received six botulinum toxin type A injections for crow's feet wrinkles in six separate zones in the lateral periocular regions bilaterally. The first injection was administered in the absence of topical 4% lidocaine gel. Gel was then applied to the remaining five zones and injections were given at set time points out to 45 minutes. In study 2, blood samples were taken from baseline to 60 minutes. RESULTS: Significant anesthetic effect with topical 4% lidocaine gel was attained without occlusion in approximately 25-30 minutes. However, optimum effects were observed between 35-40 minutes after application. Additionally, topical 4% lidocaine, when used appropriately, did not produce lidocaine plasma levels associated with toxicity. CONCLUSION: Topical 4% lidocaine gel with a unique drug delivery system produces significant anesthesia without occlusion in approximately 25-30 minutes with optimal effects observed between 35-40 minutes after application. Topical 4% lidocaine gel can be used effectively and safely as a topical anesthetic in the physician's office.