A Multicenter, Randomized, Evaluator-Blinded Study to Examine the Safety and Effectiveness of Hyaluronic Acid Filler in the Correction of Infraorbital Hollows.

BACKGROUND: Hyaluronic acid injections are increasingly used for correction of infraorbital hollows (IOHs). OBJECTIVES: Examination of effectiveness (IOH correction) and safety of Restylane® EyelightTM hyaluronic acid (HAEYE, Galderma, Uppsala, Sweden) injections. METHODS: Subjects with moderate/severe IOHs, assessed using the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (via needle/cannula) (Day 1+optional Month-1 touch up) or no-treatment control. Primary endpoint was blinded evaluator-reported Month-3 response, defined as ≥1-point GIHS improvement from baseline (both sides, concurrently). Other endpoints examined investigator-reported aesthetic improvement (GAIS), subject-reported satisfaction (FACE-Q™ satisfaction with outcome; satisfaction questionnaire), and adverse events. RESULTS: Overall, 333 subjects were randomized. Month 3 GIHS responder rate was significantly higher with HA-EYE (87.4%) versus control (17.7%; p<0.001), and comparable between HA-EYE-needle and HA-EYE-cannula groups (p=0.967). HAEYE GAIS responder rate was 87.5-97.7% (Months 3-12). Mean FACE-Q Rasch-transformed scores were 64.3-73.5 (HAEYE) versus 14.1-16.2 (control) through Month 12. Subjects reported looking younger (≥71%) and less tired (≥79%) with reduced under-eye shadows (≥76%) and recovered within 3-5 hours, post-treatment. Efficacy was maintained through Month 12 (63.5% GIHS responders) and through Month 18, after Month-12 retreatment (80.3% GIHS responders; 99.4% GAIS responders; FACE-Q scores: 72.5-72.8). Forty subjects (12.7%) reported typically mild adverse events (4.9% HAEYE-needle; 20.9% HAEYE-cannula). CONCLUSION: HAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after one retreatment) with needle or cannula administration. Safety outcomes were reassuring.

A Novel Approach to Shaping the Lateral Abdomen: Simultaneous Application of High-Intensity Focused Electromagnetic (HIFEM) Therapy and Synchronized Radiofrequency at the Flanks: A Multicenter MRI Study.

BACKGROUND: An accumulation of adipose tissue on the lateral abdomen (flanks) coupled with muscle deconditioning negatively affects core stability, muscular balance, and the intrinsic strength essential for maintaining optimal body mechanics and posture. This lateral fat accumulation and diminution of muscle result in an unfavorable abdominal profile and present challenges in finding appropriately fitting attire. OBJECTIVES: The aim of this study was to explore the effectiveness and safety of the simultaneous application of high-intensity focused electromagnetic (HIFEM) therapy and synchronized radiofrequency for sculpting the lateral abdomen. METHODS: All patients were scheduled to undergo four 30-minute treatments at approximately weekly intervals and then subsequent follow-up visits at 1 month and 3 months after the last treatment. The primary evaluation assessed changes in the oblique muscles, adipose tissue thickness, and cross-sectional area (CSA) by MRI performed at baseline and follow-ups. The secondary outcomes included digital photographs of the treated areas, a Subject Satisfaction Questionnaire, and a Therapy Comfort Questionnaire. Adverse events and side effects were monitored throughout the study duration. RESULTS: The muscle tissue showed a substantial increase in thickness (+27.2%) and CSA (+29.0%). The adipose tissue measurements showed a decrease of -30.5% in CSA and -28.8% in thickness. As secondary outcomes, 81.8% of patients reported feeling more toned, and 84.9% of patients found the treatment comfortable and reported less than mild pain. CONCLUSIONS: Based on the evaluation, the study suggests that the simultaneous application of HIFEM and synchronized radiofrequency is safe and effective for reducing adipose tissue and strengthening muscle in the area of the lateral abdomen.

Improvement in Cellulite Appearance After a Single Treatment Visit With Acoustic Subcision: Long-Term Findings From a Multicenter Clinical Trial.

BACKGROUND: Cellulite is an aesthetically displeasing rippling or dimpling of the skin, primarily on the buttocks/thighs. A recent study showed a novel acoustic subcision device produced significant short-term (12-week) improvement in the appearance of cellulite after a single rapid acoustic pulse (RAP) treatment. OBJECTIVE: To evaluate the long-term (>52-weeks) efficacy and safety of RAP treatment for improvement in the appearance of cellulite. MATERIALS AND METHODS: In this prospective, multicenter trial, female participants ( n = 42) with severe cellulite were treated with the acoustic subcision device in a single visit. At >52 weeks, blinded board-certified dermatologists assessed efficacy by correctly identifying post-treatment photographs and using a 6-point simplified Cellulite Severity Scale (CSS). Participant satisfaction was also collected. Safety was assessed throughout. RESULTS: The blinded panel correctly identified post-treatment photographs at a rate of 95.2%; 70.4% of participants had a >1-point reduction in the CSS score from baseline (mean reduction of 1.09). All participants (100%) reported improved cellulite appearance. Overall pain during treatment was rated as 2.4 and 0.3 post-treatment (pain scale 0-10). No device or treatment-related adverse events were reported at the >52-week follow-up. CONCLUSION: Rapid acoustic pulse treatment significantly improved the long-term appearance of cellulite and was well-tolerated.

Cellulite: Current Treatments, New Technology, and Clinical Management.

BACKGROUND: Cellulite is a well-known concern for many women; however, treatment can prove challenging because of the complexities of cellulite etiology, the various factors contributing to its appearance, and the multitude of therapies and procedures available. OBJECTIVE: To discuss current cellulite treatment options and effective clinical management. METHODS: A roundtable meeting was convened to discuss and share views on current cellulite treatment options, new technologies, and clinical management. The participants' views helped guide a narrative review on this topic. RESULTS: Advanced interventions for cellulite treatment-such as physical and acoustic subcision, radiofrequency, and injectable biostimulators-are gradually being established, with accumulating evidence showing efficacy, patient satisfaction, and potentially long-lasting outcomes. Cellulite severity rating scales are necessary for assessing treatment outcomes, but these can be complex to use in clinical practice, and the majority do not include patient or clinician perspectives. CONCLUSION: With the advent of new treatments and technologies, cosmetic surgeons and dermatologists will need to tailor their approach to each patient's needs and manage patient expectations because multimodal methods are likely to be required to address the various factors underlying cellulite appearance.

Improvement in the appearance of cellulite and skin laxity resulting from a single treatment with acoustic subcision: Findings from a multicenter pivotal clinical trial.

INTRODUCTION AND OBJECTIVES: Surface depressions and skin laxity together play a role in the appearance of cellulite. Cellulite depressions can be improved through disruption of the subcutaneous fibrous structures. Some currently utilized approaches accomplish this through invasive techniques requiring local anesthesia and potential down time. Skin laxity can exacerbate the appearance of cellulite, however current invasive approaches do little to improve skin laxity. The objective of this study was to evaluate a noninvasive approach to improving both cellulite depressions and skin laxity through the use of rapid acoustic pulses (acoustic subcision). Safety, efficacy, tolerability, and participant satisfaction results were measured. METHODS: Women (n = 56) with moderate to severe cellulite were treated in a single acoustic subcision treatment session without anesthesia. Posttreatment adverse events (AEs) and tolerability were recorded. At 12-weeks cellulite outcomes were assessed using a 6-point simplified Cellulite Severity Scale (CSS), Global Aesthetic Improvement Scale (GAIS), and a participant satisfaction questionnaire. Additionally, laxity improvement was measured using a 4-point Laxity Score (LS) and GAIS. RESULTS: Improvement in cellulite appearance measured at 12-weeks showed that participants (n = 56) had a mean CSS reduction of 1.01 (a 29.5% reduction from baseline). The posttreatment photograph was correctly identified by blinded independent reviewers from randomized pairs of pre/posttreatment photographs for 96.4% of participants. Cellulite was graded as improved, much improved or very much improved using the GAIS at 90.9% of treated locations. Finally, 92.9% of participants reported positive satisfaction responses. Scoring for improvement in skin laxity appearance at 12-weeks showed a mean LS reduction of 0.57 (a 27.9% reduction from baseline). GAIS for laxity was graded as improved, much improved or very much improved in 67.3% of treated areas. No unexpected or serious AEs were noted at treatment or follow-up. Overall average pain score during treatment was 2.4 (0-10 pain scale) and 0.3 immediately posttreatment. CONCLUSION: A single noninvasive acoustic subcision session can safely provide meaningful improvement in the appearance of cellulite in terms of depressions, as well as skin laxity, with minimal treatment pain and no posttreatment down time. Further improvement in appearance is expected with multiple treatments over time. Additional trials to verify this are planned.

Efficacy and Safety of Simultaneous Application of HIFEM and Synchronized Radiofrequency for Abdominal Fat Reduction and Muscle Toning: A Multicenter Magnetic Resonance Imaging Evaluation Study.

BACKGROUND: Radiofrequency and high-Intensity Focused Electromagnetic (HIFEM) field procedure are well-known, stand-alone, body-shaping modalities, yet their simultaneous application has not been investigated. OBJECTIVE: The aim is to evaluate the efficacy of a novel device simultaneously delivering HIFEM and radiofrequency for subcutaneous fat reduction and muscle toning. MATERIALS AND METHODS: Forty-one subjects with an average age of 39.7 ± 11.5 years were recruited. The subjects received 3 abdominal treatments (one per week). Magnetic resonance imaging images of the treated area were evaluated at baseline and at 1-, 3-, and 6-month visits for changes in subcutaneous fat, muscle thickness, and abdominal separation (AS). Anthropometric data and digital photographs were collected. Subject satisfaction and therapy comfort were evaluated. RESULTS: The muscle mass increase peaked at 3 months, showing 26.1% thickening. The fat thickness reduction was most prominent at 3 months, showing a 30.8% reduction. The AS decreased by 18.8% at 3 months after treatment. The waist circumference reduced by 5.87 ± 3.64 cm at a 3-month follow-up. Six-month data showed maintenance of these outcomes. The treatment was considered as comfortable with high patient satisfaction. CONCLUSION: The analysis of magnetic resonance imaging images and waist measurements showed that the therapy combining HIFEM and radiofrequency is highly effective in reducing subcutaneous fat and muscle thickening.

A Multicenter Study to Evaluate Subject Satisfaction With Two Treatments of AbobotulinumtoxinA a Year in the Glabellar Lines.

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

Simultaneous Changes in Abdominal Adipose and Muscle Tissues Following Treatments by High-Intensity Focused Electromagnetic (HIFEM) Technology-Based Device: Computed Tomography Evaluation

Objective: This study investigates the effects of high-intensity focused electromagnetic technology for induction of changes in abdominal muscles and abdominal subcutaneous fat. Methods: 22 male and female subjects (aged 34 to 64, mean BMI, 23.5kg/m2) underwent 8 treatments of the abdomen (2 per week) with a high-intensity focused electromagnetic field device. Subjects were scanned by computed tomography (CT) at baseline and 1 month after the eighth treatment. Sub-umbilical and epi-umbilical slices were used to measure the thickness of subcutaneous fat and abdominal muscles and the abdominal separation. In addition, standardized photographs, weight, and circumference measurements were collected. Results: While comparing baseline to follow-up measurements, CT data showed on average 17.5% (-3.1±1.9mm) reduction in subcutaneous fat and simultaneous 14.8% (+1.5±0.8mm) thickening of the rectus abdominis muscle. Subjects lost on average 3.9±3.1cm in the waist circumference. Most of the waist reduction effect was achieved after the fourth treatment. The width of abdominal separation decreased by 9.5% (-2.0±1.7mm). All results were highly significant (P<0.01) while weight change was insignificant (P<0.05). Digital photographs showed aesthetic improvement in most subjects. The treatments were painless and without adverse events. Conclusion: Results suggest that the investigated device is effective for abdominal body sculpting. This technology produced rectus muscle hypertrophy and a reduction in subcutaneous abdominal fat. Data suggests 4 treatments as the ideal protocol delivering 86% of the observed improvement. J Drugs Dermatol. 2019;18(11):1098-1102.

A Review and Update of Treatment Options Using the Acne Scar Classification System.

BACKGROUND: An unfortunate consequence of acne vulgaris is residual scarring that can negatively affect a patient's quality of life. OBJECTIVE: Jacob and colleagues have previously described an acne scar classification system based on acne scar pathology that divided atrophic acne scars into icepick, rolling, and boxcar scars, and this review will evaluate new and developing treatment options for acne scarring. METHODS: A Medline search was performed on the various treatments for acne scars, and particular attention was placed on articles that used the acne scar classification system of icepick, rolling, and boxcar scars. RESULTS: Therapies for acne scarring included surgical modalities, such as subcision, and punch excision and elevation, injectable fillers, chemical peels, dermabrasion, microneedling, and energy-based devices. In the past decade, there has been a trend toward using cosmetic fillers and energy-based devices to improve acne scarring. CONCLUSION: There were few high-quality evidence-based studies evaluating the management of acne scarring. Many disparate acne severity scores were used in these studies, and the acne scar type was frequently undefined, making comparison between them difficult. Nonetheless, research into interventions for acne scarring has increased substantially in the past decade and has given patients more therapeutic strategies.

Safety and efficacy of a novel high-intensity focused electromagnetic technology device for noninvasive abdominal body shaping.

BACKGROUND: Thermal fat reduction technologies are leading the market for nonsurgical abdominal contouring. However, they are ideal principally for patients with fat bulges. OBJECTIVES: Our study investigates the effects of a novel nonthermal technology affecting the abdominal musculature and subcutaneous adipose tissue. MATERIALS AND METHODS: A total of 22 patients (avg. BMI 23.8 kg m-2 ) underwent 4 treatments on abdomen with high-intensity focused electromagnetic (HIFEM) field device. Treatments took 30 minutes and were spaced apart by 2-3 days. Photographs, weight, and waist measurements were taken at the baseline, after the last treatment, and at month 3 follow-up. Patient satisfaction was noted. Photographs were evaluated by blinded evaluators. RESULTS: The study protocol was completed by 19 patients. At month 3, the average waist size reduction was 4.37 ± 2.63 cm (P < 0.01). The evaluators identified the before image from the 3-month image 89.47% of the time. About 91% of patients reported their abdominal appearance improved, and 92% stated they are satisfied with treatment results at month 3. No adverse events occurred. CONCLUSION: Observed waist size reduction and aesthetic improvement appear to be a combination of fat reduction and increased muscle definition of abdominal wall. In lower BMI patients, the increased abdominal muscle definition was largely responsible for the improvement. This novel energy device provides an additional tool for body contouring with primary application for lower and medium BMI patients.

Treatment of hyperhidrosis with microwave technology.

Hyperhidrosis is the production of sweat above and beyond normal physiological needs, regardless of the ambient temperature, and it affects > 4% of the population. In addition, a poll showed up to 21% of the population is bothered on a daily basis by their amount of underarm sweating. Despite the large number of patients who suffer from hyperhidrosis, there are relatively few effective nonsurgical treatment options. A new, nonsurgical, lasting treatment for axillary hyperhidrosis has now been developed using microwave technology to eliminate sweat glands.

Effect of multisyringe hyaluronic acid facial rejuvenation on perceived age.

BACKGROUND: The objective of aesthetic treatments is to create a more youthful appearance. Most injectable fillers are indicated for the reduction of nasolabial folds, but the current aesthetic movement is toward volume replacement in multiple areas, known as global fillers or liquid face-lift. OBJECTIVES: To quantify the degree of perceived age reduction from multisyringe hyaluronic acid treatment. MATERIALS AND METHODS: Ten women were treated with 6 to 8 mL of hyaluronic acid. Exclusion criteria were no laser for 6 months and no hyaluronic acid fillers for 6 months or semipermanent fillers for 1 year. High-resolution photographs were taken in identical lighting and position before and 2 and 4 weeks after treatment. Three blinded dermatologists rated patients' ages before and after from photographs. RESULTS: The dermatologists reported an average of 6.1 to 7.3 years of reduction in apparent age at 2 and 4 weeks, respectively. The patients perceived a decrease in apparent age of 7.8 and 9 years. CONCLUSION: Multisyringe injection of hyaluronic acid filler into the aging face results in a reduction of apparent age from 6.1 to 9 years after 2 to 4 weeks. Full-face correction with hyaluronic acid is an important procedure in the armamentarium of anti-aging techniques.

A quality rating scale for aesthetic surgical procedures.

BACKGROUND: Cosmetic dermatologic procedures offer the promise of visible aesthetic enhancement with minimal risk. While in recent years the number of available procedures has proliferated, there are few objective methods for evaluating the relative quality of these procedures for particular indications or specific patients. OBJECTIVE: (A) To develop a simple, easy-to-use numerical rating scale to assess the quality of cosmetic surgical procedures on a range of parameters pertaining to clinical efficacy and patient satisfaction; (B) to statistically validate the discriminative value of this rating scale. METHODS: (A) Patient and physician interviews were performed to elicit a list of factors that may collectively characterize the clinical efficacy and patient tolerability of cosmetic dermatologic procedures. A 0-100 point rating scale was developed based on these factors, with the face-validity of this scale checked by a group of patients and physicians; (B) Statistical analysis of the questionnaire was performed by asking 15 expert cosmetic dermatologic surgeons to use it to rate 23 common cosmetic dermatologic procedures, and analyzing the results. RESULTS: (A) An easy-to-use scale was constructed to assess the quality of cosmetic dermatologic procedures by rating the associated cost, risk, time (procedure and recovery), discomfort, results, and longevity of benefit. A "physician adjustment factor" was used to further increase the relevance of this 0-100 point scale for specific patients; (B) Repeated-measures analysis of variations (ANOVAs) performed on the data from the survey of experts demonstrated that this scale can be used to discriminate between common dermatologic procedures. The differences in mean subscores and total scores among procedures grouped by anatomic site and target lesion-type were significant at the level of P < .05. LIMITATIONS: Patient preferences exogenous to the rating scale may increase or decrease the suitability of specific procedures. CONCLUSIONS: Common cosmetic dermatologic procedures are of uniformly high quality, as per expert ratings on a systematic measure. This quality rating scale appears statistically valid and robust, given that expert raters assigned similar ratings to the same procedures but mean ratings were different across procedures. In the future, this quality rating scale can be used to assess novel interventions, and to help dermatologic surgeons faced with patient concern to optimally select among alternative procedures for a given indication.

Botulinum toxin for the treatment of facial flushing.

BACKGROUND: Facial flushing is a common problem that is encountered by fair-skinned patients of Celtic and Northern European descent. Although usually transient in nature, some patients display a persistent reddened skin tone, with periods of increased erythema. Treatment of this condition is limited. OBJECTIVE: To describe a novel method for the treatment of persistent facial flushing. METHOD: We report a case of persistent facial flushing that was resistant to multiple pulsed dye laser treatments and was successfully treated with botulinum toxin A. RESULTS: The posttreatment appearance was dramatic, and the patient was highly satisfied with the cosmetic outcome. CONCLUSION: Botulinum toxin A can be used in small quantities to decrease persistent facial flushing temporarily.

A prospective survey of patient experiences after laser skin resurfacing: results from 2 1/2 years of follow-up.

BACKGROUND: Laser skin resurfacing (LSR) is a common cosmetic surgical procedure, yet there are no prospective long-term studies on patients' perceptions of their procedure. OBJECTIVE: To prospectively document patients' subjective experiences after LSR. DESIGN: Twenty-seven consecutive patients who underwent combination carbon dioxide/erbium:YAG full-face laser resurfacing for acne scarring or photodamage were surveyed at postoperative days 1 and 3, within 1 week, at 3 weeks, 6 weeks, 3 months, and 30 months and asked standardized questions. SETTING: Referral-based academic practice. RESULTS: One day after LSR, 10 patients (37%) were concerned about the outcome, and 3 (11%) considered it a "terrible" experience. At 2.7 days after the procedure, 23 patients (85%) would recommend LSR, and after 3.7 days, 24 (89%) would have the procedure again. At 3 months, the patients' mean rating of appearance was 2.3 (0-3 scale), and all 27 (100%) felt that their appearance had been improved by LSR. After 30 months, 18 patients (75%) would recommend the procedure, 17 (71%) would have LSR again, 21 (88%) felt that their appearance was improved, and final appearance was rated 1.8 (0-3 scale). Patients undergoing LSR to treat acne scarring were as satisfied as patients treated for photodamage. CONCLUSIONS: Data on the evolution of patient perspective after LSR can improve patient preparation. This may help the surgeon and patient achieve shared, realistic expectations for the postoperative period and for long-term results.

Botulinum neurotoxin type B--a rapid wrinkle reducer.

Botulinum toxin has been used for temporary muscle paralysis for over 13 years. The off label use of neurotoxins include treatment of dynamic lines on the face and treatment of hyperhidrosis. Several forms of botulinum toxin exist, but only 2 serotypes are available commercially. Botulinum toxin B (BoTX B) is a recently US Food and Drug Administration (FDA) approved neurotoxin used for the treatment of cervical dystonia. Investigations into the use of BoTX B for skin rejuvenation have shown rapid paralysis and reduction of wrinkles. This overview highlights the current reports on the efficacy, duration, and safety of BoTX B when used for cosmetic procedures.

Tattoo-associated dermatoses: a case report and review of the literature.

BACKGROUND: Tattoos are increasingly popular in today's society, especially with the advent of laser tattoo removal. As a result, observed reactions within tattoos are likely to become more abundant. Three main classes of tattoo-associated dermopathies can be distinguished in the English literature: allergic/granulomatous/lichenoid, inoculation/infection, and coincidental lesions. Injury to the dermis, such as during placement of a tattoo, can also flare a Koebner response in patients with active susceptible disease. OBJECTIVE: This case report and review of the English literature provides a quick reference to tattoo reactions, techniques available for removal of tattoos, and disorders other than tattoos known to exhibit the Koebner response. METHODS: The English literature was reviewed via MEDLINE citations from 1966 to December 2001 to delineate articles involving tattoo reactions and Koebner reactions significant to dermatology. CONCLUSION: Numerous conditions have been documented in association with tattoos and the process of tattoo application. Awareness and identification of dermatoses associated with tattoos, tattoo removal options, and conditions associated with the Koebner response are important to both the dermatologist and dermatologic surgeon.

The corset platysma repair: a technique revisited.

BACKGROUND: Platysma banding along with excess submental adipose tissue and sagging skin can lead to an aged appearance. Several methods for improving neck and submental contours exist, including neck liposuction, bilateral platysma plication, midline platysma plication with transection of distal fibers, necklift with skin excision, and botulinum toxin injection for platysma relaxation. With the current interest in minimally invasive procedures, surgeons and patients are searching for techniques that produce maximal improvement with minimal intervention. OBJECTIVE: To present a modified technique for maximizing neck contouring, discuss possible complications of the procedure, and describe appropriate candidates for the corset platysmaplasty. METHODS: We performed a retrospective analysis of 10 consecutive patients who underwent neck liposuction with concomitant corset platysmaplasty at our institution. RESULTS: All 10 patients achieved good to excellent submental and jawline contouring, determined by both physician and patient assessment, with no visible platysma banding at 6 months follow-up. No major complications were noted. CONCLUSION: Use of corset platysmaplasty is a safe and effective method for neck rejuvenation. This variation of platysmaplasty can be used in conjunction with neck liposuction to maximize jawline and neck contour enhancement.