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.

Evaluation of a Neck Cream Developed to Enhance Nitric Oxide Availability in Aging Skin.

BACKGROUND: To meet the unique needs of aging skin of the neck, a new neck cream that enhances nitric oxide availability has been developed to visibly improve signs of aging and overall quality of skin. METHODS: The primary objective of this dual center, open label clinical trial was to assess the efficacy and tolerability of the new neck cream applied twice daily over 12 weeks in aging women with mild-to-moderate lines and wrinkles of the neck (Group 1, N=26). A second group with mild-to-moderate lines and wrinkles and photodamage of the neck and décolleté (Group 2, N=10) applied the neck cream (AM/PM) in combination with a double-conjugated retinoid/alpha hydroxy acid (AHA-Ret; PM) to both the neck and décolleté over 12 weeks. RESULTS: Group 1 demonstrated significant improvements from baseline in the neck of 21% (P=.007) for wrinkles and lines, 27% (P=.004) for skin texture, and 26% (P=.003) for skin tone at 12 weeks. Significant improvements were also observed at 4 and 8 weeks. In Group 2, significant improvements were observed from baseline in the neck and décolleté areas with a 34% (P=.01) improvement in photodamaged skin in the décolleté area. The neck cream was well tolerated with few mild and transient adverse events. CONCLUSION: A new neck cream formulated to enhance nitric oxide availability to the skin when applied alone or in combination with AHA-Ret provided statistically significant improvements from baseline in skin appearance of the neck and décolleté, most notably in lines and wrinkles, skin texture, and skin tone. CITATION: Robinson DM, Kaufman J, Giannini A, et al. Evaluation of a neck cream developed to enhance nitric oxide availability in aging skin. J Drugs Dermatol. 2023;22(9):881-886. doi:10.36849/JDD.7210.

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.

Efficacy and Tolerability of a Double-Conjugated Retinoid and Alpha Hydroxy Acid Cream in Subjects With Mild to Moderate Blemish-Prone Skin.

BACKGROUND: Topical retinoids influence the rate of cellular turnover and improve skin clarity and photoaged skin. Consequent cutaneous irritation reduces adherence resulting in suboptimal outcomes. A formulation comprised of a double-conjugated molecule containing a retinoid and an alpha hydroxy acid (AHA) has been purposefully developed for individuals with blemish-prone skin. DESIGN AND METHODS: A 12-week study conducted in subjects with mild/moderate blemish-prone skin evaluated skin clarity utilizing the Investigators Global Assessment Scale (0-Clear to 4-Severe). Changes in the appearance of pores were evaluated using a 6-point scale (0-None to 5-Severe). Adverse Events (AEs) and subject satisfaction were captured. A secondary analysis evaluated visible, quantitative changes in pores. RESULTS: Twenty subjects enrolled; 19 subjects completed the study. Mean percent improvements in appearance from baseline in skin clarity were demonstrated at weeks 4 (43%; P<.0001), 8 (48%; P<.0001) and 12 (50%; P<.0001). Mean percent visible improvements from baseline in pores were observed at 4, 8, and 12 weeks (33% [P<.0001]; 21% [P=.04] and 25% [P=.0006], respectively). AEs were mild and transient. By 8 weeks, all subjects reported improvement in overall appearance and that their skin was healthier looking. Secondary quantitative analysis (n=6) demonstrated an 18% mean improvement in the appearance of pores from baseline at week 12. CONCLUSIONS: A double-conjugated retinoid/AHA cream specifically developed for individuals with blemish-prone skin demonstrated early improvements in the appearance of skin clarity and pores over 12 weeks. AEs were mild and transient. Subjects reported high levels of satisfaction in the overall appearance and quality of skin. J Drugs Dermatol. 2022;21(1):54-59. doi:10.36849/JDD.6415.

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.

Evaluation of Picosecond 755-nm Alexandrite Laser With a Diffractive Lens Array on Pore Size Reduction.

OBJECTIVES: Medications, lasers and light therapy have all been shown to transiently minimize pore size. Current research of the 755-nm Alexandrite picosecond laser (Cynosure, MA) on pore size shows differing results regarding the efficacy, with one study of Asian volunteers (Fitzpatrick skin type IV) reporting “marked” improvement of pores, yet another study reporting no significant improvement in pore size in Chinese patients (Fitzpatrick skin type III–IV), causing some contention. This study aims to rectify the discordant results through the examination of the 755-nm Alexandrite picosecond laser on pore size reduction in a sample consisting of Fitzpatrick skin type I–III. METHODS: Patients who received 755-nm Alexandrite picosecond laser treatment for photorejuvenation, (6 mm lens array) with a fluence of 0.71 J/cm2 of the face or head, with at least two treatments over four-week intervals were included in the study. A precision subject imaging system (Canfield VISIA® Complexion Analysis Generation 7, NJ) was used to assess three parameters of pore size (feature count, score, percentile rank) at each time period at right lateral, left lateral and frontal views. A Wilcoxin signed rank test was performed to compare differences between time periods and a mixed model ANOVA was utilized to account for patients who received less than three treatments. Significance level set to P=<0.05. RESULTS: 32 participants met criteria and underwent at least two picosecond laser treatments for photorejuvenation. There was an overall reduction in pore count in approximately 57% of participant data points from times 1 to 2 and 50% reduction from times 2 to 3. There was a 100% pore count reduction observed from baseline compared with the follow-up visit four weeks after the third treatment, at time 4. Further, there was a significant improvement of pores demonstrated by score from times 1 to 3 (Z= -2.197, P=0.028) as well as percentile rank between times 1 and 2 (Z= -2.070, P=0.038) and times 1 and 3 (Z= -2.201, P=0.028). CONCLUSION: Future studies should investigate the longterm effect of 755-nm Alexandrite picosecond laser on pore size reduction as continued patient recruitment and data collection is necessary to effectively discern the 755-nm Alexandrite picosecond laser debate. Thus, prolonged follow up post treatment should be evaluated in order to determine if results are maintained. Nonetheless, the 755-nm Alexandrite picosecond laser shows promising results for the improvement of skin pores thus far. J Drugs Dermatol. 2021;20(12):1302-1306. doi:10.36849/JDD.6199.

AbobotulinumtoxinA Treatment of Glabellar Lines Using a New Reconstitution and Injection Volume: Randomized, Placebo-Controlled Data.

BACKGROUND: Increasing the reconstitution and injection volumes of abobotulinumtoxinA (aboBoNT-A) could provide more options for aesthetic healthcare professionals. OBJECTIVE: To evaluate efficacy and safety of aboBoNT-A treatment of moderate-to-severe glabellar lines (GL) versus placebo, using a new reconstitution and injection volume. Methods & Materials: In this 6-month, Phase III, randomized, double-blind study, subjects 18-64 years were administered aboBoNT-A 50 U (N=224) or placebo (N=77), as five 0.1-mL-injections (10 U) in the glabellar region following reconstitution of a 300-U-vial in 3 mL. Assessments included time to onset of effect, investigator- (ILA) and subject- (SSA) assessed GL severity, subject satisfaction, aesthetic improvement and safety. The primary endpoint was composite 2-grade response at month 1 (a GL severity of none-or-mild at maximum frown and ≥2-grade improvement from baseline concurrently on both ILA and SSA). RESULTS: Median time to onset was 2 days, 34% of subjects reporting effect on day 1. At month 1, the composite 2-grade responder rate was 65.8% for aboBoNT-A versus 0% for placebo, P<0.001, 91–92% had none-or-mild GL severity, and 95–100% had a ≥1-grade GL severity improvement. A ≥1-grade improvement was sustained in 46-56% of aboBoNT-A-treated subjects up to 6 months (P<0.001 vs placebo). Aesthetic improvement and subject satisfaction were high throughout 6 months and aboBoNT-A treatment was well tolerated. CONCLUSION: Safety and efficacy of GL treatment using 0.1 mL (10 U) aboBoNT-A per injection site were demonstrated, with rapid onset and up to 6 months’ duration of effect. Severity improvement was accompanied by sustained aesthetic improvement and subject satisfaction. J Drugs Dermatol. 2021;20(9):988-995. doi:10.36849/JDD.6130.

Intraarterial Degradation of Calcium Hydroxylapatite Using Sodium Thiosulfate - An In Vitro and Cadaveric Study.

BACKGROUND: The most severe complications following soft tissue filler injections result from the intraarterial administration of the filler product. Although hyaluronic acid-based filler can be trans-arterially dissolved with hyaluronidase, no information is available on calcium hydroxylapatite (CaHA)-based fillers. OBJECTIVE: The authors sought to test whether CaHA-based fillers can be trans-arterially dissolved by sodium thiosulfate (STS) when evaluated in cadaveric and in vitro models. METHODS: Human cadaveric facial arterial segments were each filled with 0.2 cc of commercially available CaHA product and submerged for 24 hours in 4 different STS-containing solutions: 10 cc STS (300 mg/cc) (pure, 1:1 dilution, 1:2 dilution), 0.9% saline and 10 cc STS (300 mg/cc), and 300 IU (bovine) hyaluronidase in a 1:1 ratio. RESULTS: Intraarterial CaHA was detected in human facial artery segments after 24 hours independent of the STS concentration employed. Submerging the arterial segments in STS (300 mg/cc) and 300 IU (bovine) hyaluronidase (1:1 ratio) also did not dissolve the intraarterial CaHA product. Gray scale analyses did show, however, that increasing concentrations of STS resulted in increased disintegration of CaHA in an in vitro experimental setting. CONCLUSIONS: The results of this study indicate that STS is limited in its potential to dissolve intraarterial CaHA of cadaveric human facial arteries, despite the fact that it appears effective when in direct contact with the CaHA. Adverse events caused by intraarterial administration of CaHA-based fillers still lack a suitable antidote.

Efficacy and safety of oxymetazoline cream 1.0% for treatment of persistent facial erythema associated with rosacea: Findings from the 52-week open label REVEAL trial.

BACKGROUND: Limited treatments are available for persistent erythema of rosacea. OBJECTIVE: To examine the long-term safety and efficacy of oxymetazoline cream 1.0% in patients with rosacea with moderate-to-severe persistent erythema. METHODS: Patients applied oxymetazoline once daily for 52 weeks. Safety assessments included treatment-emergent adverse events (TEAEs), skin blanching, inflammatory lesion counts, telangiectasia, disease severity, and rebound effect. Efficacy was assessed by the Clinician Erythema Assessment and Subject Self-Assessment composite score at 3 and 6 hours after the dose on day 1 and at weeks 4, 26, and 52. RESULTS: Among 440 patients, 8.2% reported treatment-related TEAEs; the most common were application-site dermatitis, paresthesia, pain, and pruritus. The rate of discontinuation due to adverse events (mostly application-site TEAEs) was 3.2%. No clinically meaningful changes were observed in skin blanching, inflammatory lesions, or telangiectasia. At week 52, 36.7%, and 43.4% of patients achieved a 2-grade or greater composite improvement from baseline in both Clinician Erythema Assessment and Subject Self-Assessment 3 and 6 hours after a dose, respectively. Less than 1% of patients experienced a rebound effect following treatment cessation. LIMITATIONS: A vehicle-control group was not included. CONCLUSION: This long-term study demonstrated sustained safety, tolerability, and efficacy of oxymetazoline for moderate-to-severe persistent erythema of rosacea.

In Vitro Analysis of the Degradation of Calcium Hydroxylapatite Dermal Filler: A Proof-of-Concept Study.

BACKGROUND: A dissolving agent for calcium hydroxylapatite (CaHA, Radiesse) soft-tissue filler would be of value should inadvertent intravascular injection, vascular compromise, nodule formation, or overcorrection occur. METHODS: In a prospective, single-center, proof-of-concept study, 12 cadaveric porcine skin samples were injected with CaHA (0.4-0.8 mL). Samples were then randomized to intralesional injection of 0.2-mL sodium thiosulfate (STS, 12.5 g/50 mL); 1 to 2 g of topical sodium metabisulfite (SMB, 25% SMB in 120-mL gel) applied with occlusion, or both intralesional STS and topical SMB. Control samples were not treated after CaHA injection. A 4-mm punch biopsy was obtained 24 hours after treatment, and tissue sections were stained with hematoxylin and eosin and prepared for light microscopy. A board-certified dermatopathologist estimated the amount of CaHA present in each sample. RESULTS: Intralesional STS alone or combined with topical SMB completely dissolved CaHA in the porcine skin samples. Topical SMB treatment reduced, but did not entirely clear CaHA from the tissue samples. The control samples contained easily identifiable CaHA microspheres. CONCLUSION: This proof-of-concept study illustrates the potential reversibility of CaHA filler with intralesional STS, topical SMB, and the combination of both agents. Larger, in vivo, studies are now warranted to provide further insight.

A Multicenter Pivotal Study to Evaluate Tissue Stabilized-Guided Subcision Using the Cellfina Device for the Treatment of Cellulite With 3-Year Follow-Up.

BACKGROUND: Cellulite is a common female cosmetic concern for which no single treatment option had been proven effective over the long term. A novel tissue stabilized-guided subsicion system (TS-GS system) has demonstrated significant reduction in the appearance of cellulite after treatment. OBJECTIVE: The objective of this extended follow-up period was to assess the effectiveness of TS-GS out to 3 years after initial treatment. PATIENTS AND METHODS: After completing an open-label, multicenter, pivotal study, 45 subjects were followed for an extended period of up to 3 years after receiving a single treatment using the TS-GS system. Treatment areas were photographed prior to the procedure and at multiple time points post-treatment throughout the 3 years. In this open-label study, subjects served as their own controls. Effectiveness was assessed based on blinded independent physician panel assessments of improvement from baseline using a cellulite severity scale. Subject aesthetic improvement and patient-reported satisfaction were also collected. RESULTS: The results of this trial supported Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite following TS-GS. CONCLUSION: These data further demonstrate the safety and efficacy of this treatment with no reduction in treatment benefits out to 3 years.

Randomized, Split-Face/Décolleté Comparative Trial of Procedure Enhancement System for Fractional non-Ablative Laser Resurfacing Treatment.

INTRODUCTION: A topical proprietary procedural enhancement system (PES) containing a combination of active ingredients including a tripeptide and hexapeptide (TriHex Technology™, Alastin Procedure Enhancement Invasive System, ALASTIN Skincare™, Inc., Carlsbad, CA) has been used successfully to aid in healing and improve symptomatology following resurfacing procedures.

METHODS: PES (Gentle Cleanser, Regenerating Skin Nectar with TriHex Technology™, Ultra Nourishing Moisturizer with TriHex Technology™, Soothe + Protect Recovery Balm, Broad Spectrum 30+ Sunscreen) was compared to a basic regimen (Aquaphor™, Cerave™ cleanser, Vanicream™, Alastin Broad Spectrum 30+ Sunscreen) in a split face/ décolleté trial following fractional non-ablative thulium-doped resurfacing treatment to the face or décolleté. The skin was pre-conditioned and treated during and after the procedure using the two regimens.

RESULTS: A blinded investigator rated the PES statistically superior to the basic regimen on healing post-laser treatment on day 4 based on lentigines, texture, and Global Skin Quality. Subjects also reported 'better looking and feeling' skin on the PES side.

CONCLUSION: PES appears to improve healing post-non ablative thulium-doped resurfacing treatment to the face/décolleté in comparison with standard of care.

J Drugs Dermatol. 2017;16(7):707-710.

Noninvasive body contouring.

In a society where stigma surrounds cosmetic procedures and yet a thin and sculpted physique is idealized, noninvasive body contouring satisfies the demand to reduce excess and undesired body fat in areas that persist despite exercise and diet. Numerous devices are available to meet this need; however, choosing the "perfect" device is challenging because the science and data are often limited with variable results. In this paper, we review 7 US Food and Drug Administration-approved noninvasive body contouring therapies in hopes of providing some clarity to this area.

Cellulite: a review of pathogenesis-directed therapy.

Cellulite is a condition that affects the majority of postpubertal women and can negatively impact quality of life. This review discusses several proposed pathophysiologies of cellulite, and examines treatment options that have been utilized, focusing on the etiologic factor targeted by the therapies. This approach aims to help clarify the pathogenesis of cellulite and provide a road map for developing effective treatment paradigms for patients.

A review of melasma treatment focusing on laser and light devices.

Melasma is a pigmentary disorder of unclear etiology with numerous treatment options and high recurrence rates. Laser and light therapies may be utilized cautiously as second- or third-line options for recalcitrant melasma, but low-energy settings are preferred due to the risk of postinflammatory hyperpigmentation and melasma stimulation. Commonly used lasers include the low-fluence 1064-nm Q-switched neodymium-doped yttrium aluminum garnet laser, nonablative fractionated lasers, and intense pulsed light. Strict sun protection, concomitant use of bleaching agents, and maintenance treatments are necessary. A variety of other treatments that may also help to improve results are now being more widely adopted, including oral tranexamic acid, pulsed dye laser, antioxidants, and laser-assisted drug delivery.

Multicenter pivotal study of vacuum-assisted precise tissue release for the treatment of cellulite.

BACKGROUND: Cellulite refers to the dimpled appearance of skin occurring where the dermis is tethered by subcutaneous fibrous septa arranged perpendicularly to the skin surface. OBJECTIVE: To demonstrate the safety and efficacy of a new system for vacuum-assisted precise tissue release for the treatment of cellulite. MATERIALS AND METHODS: Adult women with moderate to severe cellulite (N = 55) underwent a single treatment. Post-treatment assessments were performed after 3 and 14 days; 1, 3, and 6 months; and at 1 year. Outcome measures included blinded assessments of subject photographs, a validated Cellulite Severity Scale (CSS), and the Global Aesthetic Improvement Scale. Subject satisfaction and pain ratings were also recorded. RESULTS: The mean baseline CSS score of 3.4 decreased to 1.3 at 3 months (p < .0001) and 1.4 at 1 year (p < .0001), with 47 subjects (93%) having ≥1-point improvements. Subject satisfaction was 85% at 3 months and 94% at 1 year. Transient treatment-related adverse events were mild in severity. CONCLUSION: This study demonstrates the safety, efficacy, and subject satisfaction with vacuum-assisted precise tissue release in the treatment of cellulite. There was no reduction in treatment benefits for up to 1 year. These results supported the Food and Drug Administration clearance of the device for the long-term reduction in the appearance of cellulite.

High-intensity focused ultrasound for the reduction of subcutaneous adipose tissue using multiple treatment techniques.

BACKGROUND: High-intensity focused ultrasound (HIFU) is a noninvasive alternative to traditional invasive body sculpting procedures. OBJECTIVE: To assess the effectiveness and tolerability of HIFU treatment using high and low fluence settings with 2 treatment techniques, grid repeat (GR) and site repeat (SR). MATERIALS AND METHODS: Two multicenter studies were conducted. Subjects underwent 1 HIFU treatment with 1 of 5 treatment protocols (total fluence, 150-180 J/cm). Primary end point was change from baseline in waist circumference (CBWC) at 12 weeks. Secondary end points included CBWC at 4 and 8 weeks and investigator- and subject-assessed clinical improvement. Adverse events were monitored throughout the study. RESULTS: In the intent-to-treat (ITT) population, all subjects had a statistically significant mean circumferential reduction of -2.3 ± 2.9 cm (p < .0001) from baseline at 12 weeks, with no significant differences among the 5 treatment groups (ITT: p = .153). Analysis of secondary end points in the ITT population demonstrated a significant circumferential reduction starting as early as 4 weeks in all subjects (-1.1 ± 1.9 cm, p < .0001). Most subjects in all treatment groups showed improvements at 12 weeks as rated by the investigators and subjects. CONCLUSION: High-intensity focused ultrasound treatment using either a low or high fluence setting in a GR or SR method is effective for circumferential waist reduction, resulting in statistically significant CBWC in all treatment groups.

Updates in noninvasive and minimally invasive skin tightening.

The demand for noninvasive and minimally invasive skin-tightening procedures is rising within the aesthetic world. Although these treatments will not replace surgery,a growing patient population is seeking results through low-risk procedures with associated minimal downtime.The technology within this realm is changing due to an increased ability to safely deliver energy to deeper tissue planes. Within the last year alone, research has led to the introduction of a subdermal radiofrequency device, advancements in minimally invasive lasers, and the use of microfocused ultrasound off the facial tissue. Through research studies, protocols are being optimized and clinical results are becoming more reliable.