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    Gary Monheit

    With so many new peel preparations on the market today, the dermatologist must ask himself basic questions concerning the products. The most important question is directed to the medical literature rather than the advertising or marketing... more
    With so many new peel preparations on the market today, the dermatologist must ask himself basic questions concerning the products. The most important question is directed to the medical literature rather than the advertising or marketing campaign so common among market-driven cosmetic products. Since all peeling agents--superficial, medium depth and deep--are derived from basic chemicals known to cause exfoliation, destruction and/or inflammation of skin in a controlled manner, the clinician must ask what is new and better about the product. Peeling agents, regardless of their proprietary new name, fall into chemical families. The clinical evaluation of these generic agents is well documented in our literature as to efficacy, technical care and safety. In addition, combinations of peeling agents have been presented in the dermatologic cosmetic literature with scientific clinical trials and histology. These include: 1) The Gordon-Baker phenol peel; 2) Combination medium depth peelin...
    BACKGROUND A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA) chains with reduced cross-linking was developed for aesthetic procedures. OBJECTIVE The efficacy, durability, and safety of 2 of these... more
    BACKGROUND A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA) chains with reduced cross-linking was developed for aesthetic procedures. OBJECTIVE The efficacy, durability, and safety of 2 of these resilient HA (RHA) fillers, and their noninferiority to an effective HA comparator available in the United States, were tested in the treatment of dynamic facial wrinkles. METHODS A 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial was carried out on 174 subjects presenting moderate-to-severe bilateral nasolabial folds (NLFs). Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators. Self-perception was evaluated with FACE-Q and satisfaction scales. RESULTS The per-protocol populations included 67 and 62 subjects of all Fitzpatrick skin-phototypes, in the 2 comparison groups. Significant improvement of mean WSRS scores and associated responder rates established the noninferiority of RHA fillers to their comparator, over 15 months. Aesthetic improvement and subject satisfaction were durably high, with no meaningful differences between the fillers. Treatments were safe and well tolerated. CONCLUSION The 2 RHA fillers are at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin-phototypes.
    Not AvailableDisclosures: Study supported by Allergan.
    Background Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform. Objectives The authors sought to evaluate the safety and effectiveness of... more
    Background Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform. Objectives The authors sought to evaluate the safety and effectiveness of Vollure for correction of moderate to severe nasolabial folds (NLFs) over 18 months and after repeat treatment. Methods In this prospective, randomized study, patients (N = 123) received initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF. Patients received optional repeat treatment with Vollure after month 12, 15, or 18. Assessments included investigator-rated NLF Severity Scale responder rates (≥1-point improvement vs baseline), patient-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire, and patient satisfaction (11-point scale). Results Median volume of Vollure injected was 1.7 mL for initial/touch-up treatment combined and 0.6 mL for repeat treatment. The NLF Severity Scale responder rat...
    A recent survey done by the American Society for Dermatologic Surgery indicated that 67% of respondents were bothered by "excess fat under the chin/neck." Accumulation of fat in the preplatysmal compartment of the neck is a... more
    A recent survey done by the American Society for Dermatologic Surgery indicated that 67% of respondents were bothered by "excess fat under the chin/neck." Accumulation of fat in the preplatysmal compartment of the neck is a common cause for fullness in the submental area. In the past, surgical liposuction was the only option to remove fat in the submental area. Although effective, liposuction does have risks and downtime. Recently, noninvasive options for treatment of submental fat have been introduced. These include treatment with deoxycholic acid, known as Kybella®, and cryolipolysis using the CoolMini™ handpiece. Both of these treatments offer less downtime fewer potential risks than the surgical counterpart. This article summarizes these two procedures and describes noninvasive approaches to treatment of submental fat.
    A comparison of efficacies, costs, and effects on vaginal microflora of one preoperative and three postoperative 1-g doses of cefazolin versus those of one preoperative 1-g dose of ceftriaxone was done with 65 and 73 women, respectively,... more
    A comparison of efficacies, costs, and effects on vaginal microflora of one preoperative and three postoperative 1-g doses of cefazolin versus those of one preoperative 1-g dose of ceftriaxone was done with 65 and 73 women, respectively, undergoing elective vaginal hysterectomy. Patient infection rates were not statistically different between the cefazolin group (six events in 6 of 73 patients [8.2%]) and the ceftriaxone group (11 events in 9 of 65 patients [13.8%]). Side effects, including diarrhea, were minimal and similar between the two groups. Significant shifts in the cervicovaginal microflora of the patients occurred postoperatively, with a marked increase in enterococci and a drop in nonenterococcal streptococci. No shifts among aerobic, facultative gram-negative rods and staphylococci were observed. Among the anaerobes, a significant decrease in the number of patients harboring nonsporulating, gram-positive rods and a less striking concomitant increase in Bacteriodes specie...
    The use of chemoexfoliating agents to peel the epidermis and superficial dermis dates as far back as ancient Egypt, where sour milk baths were once used to soothe the skin. History has recorded the use of such chemicals as salt, sulfur,... more
    The use of chemoexfoliating agents to peel the epidermis and superficial dermis dates as far back as ancient Egypt, where sour milk baths were once used to soothe the skin. History has recorded the use of such chemicals as salt, sulfur, and various animal oils to exfoliate the skin for therapeutic and cosmetic purposes.1 The modern era of chemoexfoliation began in the early twentieth century, with phenol used as a peeling agent for post-acne scarring.
    Juvéderm Vollure XC (VYC-17.5L) belongs to a family of nonanimal hyaluronic acid (HA) gels based on the Vycross technology platform. To evaluate the safety and effectiveness of VYC-17.5L for correction of moderate to severe nasolabial... more
    Juvéderm Vollure XC (VYC-17.5L) belongs to a family of nonanimal hyaluronic acid (HA) gels based on the Vycross technology platform. To evaluate the safety and effectiveness of VYC-17.5L for correction of moderate to severe nasolabial folds (NLFs) compared with a control HA dermal filler. In this double-blind study, 123 adults with 2 moderate or severe NLFs as measured on the 5-point photonumeric NLF severity scale (NLFSS) were randomized to VYC-17.5L in 1 NLF and control in the contralateral NLF. The coprimary effectiveness end points at Month 6 were difference in improvement in mean NLFSS score for VYC-17.5L versus control and NLFSS responder rate (≥1-point improvement) for VYC-17.5L. The coprimary effectiveness end points were met. NLFSS scores improved by 1.4 with VYC-17.5L and by 1.3 with control; NLFSS responder rate with VYC-17.5L was 93.2%. More than three-quarters of subjects (82%) treated with VYC-17.5L were very satisfied at Month 6. Investigators reported that VYC-17.5L ...
    Botulinum toxin (BoNT) has been approved for aesthetic use since 2002. Since then, clinical studies and expert use have informed our understanding of how BoNT exerts its clinical effect and the practical use of this product across a... more
    Botulinum toxin (BoNT) has been approved for aesthetic use since 2002. Since then, clinical studies and expert use have informed our understanding of how BoNT exerts its clinical effect and the practical use of this product across a number of aesthetic applications. This review discusses the clinical properties and characteristics of abobotulinumtoxinA, which patients are suitable for its use, and how it can be utilized to treat facial rhytides.
    Hyaluronic acid fillers are a versatile genre that may be used for safe and efficacious volume restoration to the face and body with a variety of techniques. Understanding of the manufacturing processes for different products, and how... more
    Hyaluronic acid fillers are a versatile genre that may be used for safe and efficacious volume restoration to the face and body with a variety of techniques. Understanding of the manufacturing processes for different products, and how these determine their physicochemical characteristics and consequent clinical behavior, can aid in the selection of appropriate products and injection techniques for each application and also help to prevent some complications. J Drugs Dermatol. 2012;11(suppl 3): s15-s27.
    ABSTRACT Part I of this two-part supplement brings together experts from the U.S., Europe, Canada, and Israel to discuss the state-of-the-art in soft tissue fillers in a fair-balanced, CME-accredited format. It includes a roundtable... more
    ABSTRACT Part I of this two-part supplement brings together experts from the U.S., Europe, Canada, and Israel to discuss the state-of-the-art in soft tissue fillers in a fair-balanced, CME-accredited format. It includes a roundtable discussion on hyaluronic acid (HA) fillers that charts the clinical and scientific path that has led dermatologists from wrinkle-chasing to true volumetry. International case vignettes with commentary highlight a variety of applications for fillers'some currently available in the U.S., and some available elsewhere and on the American horizon. Topics covered include single-product and multi-product volumetry, anatomic and safety considerations, and the use of blunt injection microcannulas. Quick poll surveys provide an engaging snapshot of the faculty's personal approaches, with the first three surveys focusing on the palette of HA fillers. This is a CME supplement; visit the JDD Medical Education Library to participate in this activity and earn 2 AMA PRA Category 1 Credits.
    In this roundtable discussion, the physicochemical properties and potential clinical applications of two new ranges of hyaluronic acid fillers are reviewed. These fillers display enhanced tissue integration after implantation due to novel... more
    In this roundtable discussion, the physicochemical properties and potential clinical applications of two new ranges of hyaluronic acid fillers are reviewed. These fillers display enhanced tissue integration after implantation due to novel manufacturing processes, and one of the ranges is customized for specific clinical applications by variation of filler gel calibration and cross-linking.
    Over the past decade, the use of nonsurgical products and devices to correct facial contour defects and signs of skin aging has exploded with new lasers, toxins for muscle relaxation, and dermal fillers revolutionizing aesthetic medicine.... more
    Over the past decade, the use of nonsurgical products and devices to correct facial contour defects and signs of skin aging has exploded with new lasers, toxins for muscle relaxation, and dermal fillers revolutionizing aesthetic medicine. Of all the nonsurgical modalities employed during this period, the dermal filler industry has seen the most growth in demand. In 2006, the worldwide market for dermal fillers increased by 19%; and the US market is expected to increase a further 20% to 25%. This is due in large part to new products, particularly the hyaluronic acids such as Juvéderm, which now promise greater longevity, fewer side effects, a more natural appearance, and easier administration.
    A new formulation of botulinum toxin type A (BoNT-A) (Dysport) has recently been approved in the United States for the treatment of glabellar lines. We sought to evaluate the long-term safety of repeated administrations of this BoNT-A... more
    A new formulation of botulinum toxin type A (BoNT-A) (Dysport) has recently been approved in the United States for the treatment of glabellar lines. We sought to evaluate the long-term safety of repeated administrations of this BoNT-A formulation. In all, 768 individuals (1500 planned) from phase III clinical trials received as many as 6 repeated treatments of open-label BoNT-A (50 U) over 17 months, with a minimum of 85 days between treatments. Participants received a telephone call at day 7 postinjection to check for adverse event (AE), with clinical evaluations on days 14 and 30, and monthly until retreatment, study completion, or early termination. Safety end points were AEs, changes in vital signs, and assessment of serum-neutralizing antibodies to BoNT-A. Of the 285 participants reporting at least one treatment-emergent AE at the interim analysis cutoff, only 74 (26%) reported at least one possibly or probably related event after 2259 treatments with BoNT-A. The incidence of treatment-emergent AEs around the injection sites and eyes was low (< or = 3%). Ten participants (1%) experienced 10 instances of ptosis. No participants developed neutralizing antibodies to BoNT-A or clinically significant changes in vital signs. This is an interim analysis of a larger multicenter extension study. Multiple treatments with BoNT-A (50 U) over 17 months were well tolerated.
    Pain during and after implantation of dermal gel fillers is a consistent complaint of patients undergoing soft tissue augmentation. Reduction of pain during injection would increase patient comfort and improve the overall patient... more
    Pain during and after implantation of dermal gel fillers is a consistent complaint of patients undergoing soft tissue augmentation. Reduction of pain during injection would increase patient comfort and improve the overall patient experience. To evaluate pain at the injection site during and after the injection of Prevelle SILK or Captique and to evaluate outcomes after 2 weeks. In a patient-blinded, prospective, randomized, split-face design trial, a non-animal-derived hyaluronic acid based filler formulated with lidocaine (Prevelle SILK) was injected in one nasolabial fold (NLF), and the same filler without lidocaine (Captique) was injected in the contralateral NLF of 45 enrolled patients. Injection site pain was measured using a visual analogue scale at injection (time 0) and 15, 30, 45, and 60 minutes after injection. Patients were asked to return for an evaluation after 2 weeks and to complete a self-assessment questionnaire during the follow-up visit. There was more than 50% less pain associated with the dermal gel with lidocaine than with the same filler without lidocaine at all time points (p<.05). The greatest difference in pain was recorded at the time of injection, and then the effect gradually declined over the 60-minute period. Both fillers were well tolerated, and there was no difference in outcome after 2 weeks. Addition of lidocaine to a filler resulted in significantly less pain associated with the procedure without compromising outcomes.
    A new botulinum neurotoxin type A formulation, abobotulinumtoxinA (BoNTA-ABO; Medicis Aesthetics Inc., Scottsdale, AZ), was approved in 2009 in the United States for treatment of moderate to severe glabellar lines in adults younger than... more
    A new botulinum neurotoxin type A formulation, abobotulinumtoxinA (BoNTA-ABO; Medicis Aesthetics Inc., Scottsdale, AZ), was approved in 2009 in the United States for treatment of moderate to severe glabellar lines in adults younger than 65. OBJECTIVE To determine onset of response based on participant assessments recorded from days 1 through 7. Time to onset was assessed as a secondary endpoint in four multicenter, double-blind, placebo-controlled, randomized phase 3 trials evaluating BoNTA-ABO efficacy. Participants received 50 to 80 U of BoNTA-ABO (n=1,160) or placebo (n=580) at five injection sites in the glabellar region. Participants self-evaluated and recorded first effects. Response on day 1 was 13.4% to 32.5% in participants receiving BoNTA-ABO and 3% to 7% in those receiving placebo. Integrated analysis of three studies showed that 19.7% of participants responded by day 1; median onset was 3 days for BoNTA-ABO and 15 days for placebo. Men responded less frequently in fixed-treatment studies than in the study in which doses were adjusted for muscle mass. Treatment with BoNTA-ABO demonstrates significantly greater reduction in glabellar lines than placebo. Improvement was seen as early as 24 hours, with median time to onset of 2 to 4 days.
    Various scoring techniques prone to subjective interpretation have been used to evaluate soft tissue augmentation of nasolabial folds (NLFs). To design and validate a reliable wrinkle assessment scoring scale. Six photographed wrinkles of... more
    Various scoring techniques prone to subjective interpretation have been used to evaluate soft tissue augmentation of nasolabial folds (NLFs). To design and validate a reliable wrinkle assessment scoring scale. Six photographed wrinkles of varying severity were electronically copied onto the same facial image to become a 6-point grading scale (GGS). A pilot training program (13 investigators) determined reliability, and a 12-week multicenter survey study validated the GGS scoring method. Pilot study inter- and intrarater scoring reliability were high (weighted kappa scores of 0.85 and 0.86, respectively). Seventy-five percent of survey investigators and independent review panel (IRP) members considered a GGS score difference of 0.5 to be a minimally perceivable difference. Interrater weighted kappa scores were 0.91 for the IRP and 0.80 for investigators. Intrarater agreements after repeat testing were 0.91 and 0.89, respectively. The baseline "live" assessment GGS mean score was 3.34, and the baseline blinded photographic assessment GGS mean score was 2.00 for the IRP and 2.16 for the investigators. The GGS is a reproducible method of grading the severity of NLF wrinkles. Treatment effectiveness of a dermal filler can be reliably evaluated using the GGS by comparing "live" assessments with the standard GGS photographic panel.
    To evaluate the effect of vascular endothelial growth factor (VEGF) on full-thickness skin graft (FTSG) survival on irradiated tissue as a model of wound healing in ischemic conditions. Twenty-four Sprague-Dawley rats underwent 30 Gy of... more
    To evaluate the effect of vascular endothelial growth factor (VEGF) on full-thickness skin graft (FTSG) survival on irradiated tissue as a model of wound healing in ischemic conditions. Twenty-four Sprague-Dawley rats underwent 30 Gy of irradiation to their left dorsum (10 Gy/d). After 4 weeks of recovery, 3-cm FTSGs were harvested from the healthy contralateral dorsum and placed onto irradiated recipient beds. Before grafting, recipient beds were delivered subfascial injections of either VEGF protein (5 microg) or physiologic saline. Graft failure (more than 10% necrosis) and graft microvascular density were compared between groups. Seven of the 11 FTSGs from saline-treated irradiated beds (64%) failed, whereas the failure rate for grafts treated with VEGF was 23% (3 of 13) (P = .048). Mean microvascular density was not different between groups. Exogenously administered VEGF may improve the outcome of FTSGs on irradiated tissue beds.
    Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining your privacy and will not share your personal information without your express consent. For more information, please refer to our... more
    Wolters Kluwer Health may email you for journal alerts and information, but is committed to maintaining your privacy and will not share your personal information without your express consent. For more information, please refer to our Privacy Policy. ... Skip Navigation Links Home > April ...
    ABSTRACT BACKGROUND Dermal fillers are used to augment wrinkles and folds, and a variety of hyaluronic acid (HA)-based products are available. The non-animal-sourced HA studied was cross-linked using a two-step process and employing... more
    ABSTRACT BACKGROUND Dermal fillers are used to augment wrinkles and folds, and a variety of hyaluronic acid (HA)-based products are available. The non-animal-sourced HA studied was cross-linked using a two-step process and employing cohesive polydensified matrix (CPM) technology. This HA gel (CPMHA) has variable density and viscosity zones for adaptation in the dermis.OBJECTIVE To compare the safety and effectiveness of CPMHA with that of bovine collagen (COL) in the correction of moderate to severe nasolabial folds (NLFs) in a split-face study.METHODS AND MATERIALS One hundred eighteen subjects were randomized to receive CPMHA and COL on contralateral sides of the face. NLF severity was measured using the Wrinkle Severity Rating Scale (WSRS). The initial treatment was evaluated after 2 weeks, and an optional touch-up to optimal cosmetic correction was permitted if needed. Subjects returned every 2 weeks (up to 24 weeks) for evaluation. Safety was assessed using spontaneous adverse event (AE) reporting.RESULTS CPMHA resulted in a significantly greater reduction in the mean change of WSRS than COL at weeks 8 (p=.009), 12 (p<.001), 16 (p<.001), and 24 (p<.001). There were no significant differences between the two groups in the proportion of AEs considered related to the injection site procedure. Most AEs were mild to moderate in severity and resolved within 7 days.CONCLUSION CPMHA was well tolerated and first demonstrated to be noninferior and then superior in terms of effectiveness to COL over 24 weeks for the treatment of NLF, including the primary end point at week 12.Merz Pharmaceuticals, LLC funded this Food and Drug Administration clinical trial. Bhushan Hardas, Mandeep Kaur, Starr Grundy, and Eric Pappert are employees of Merz Pharmaceuticals.

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