Randomized, Controlled, Multicentered, Double-Blind Investigation of Injectable Poly-L-Lactic Acid for Improving Skin Quality.

BACKGROUND: Poly-L-lactic acid (PLLA) is an injectable filler used for restoring facial fat volume loss. OBJECTIVE: To evaluate the effect of repeated PLLA injections on skin quality. METHODS: Forty healthy women were enrolled in this randomized, controlled, double-blind, multicenter study. Eligible subjects received 3 treatments every 4 weeks with either PLLA (treatment group) or saline (control group) injections, into both sides of the face. Follow-up visits were at 6, 9, and 12 after the last treatment. Assessments included biophysical measuring instruments, live ratings, patient questionnaires, and rating of standardized pictures by a blinded evaluator. RESULTS: At the 12-month follow-up, there was a statistically significant increase of skin elasticity and hydration in PLLA-treated subjects and a decrease in transepidermal water loss in both groups. Pigmentation, erythema, and pore size were significantly decreased, whereas radiance and smoothness were significantly increased at 12 months per blinded investigator rating in this group. No treatment-related adverse events occurred. CONCLUSION: Repeated PLLA treatments may improve skin quality in a time-dependent manner.

Efficacy of combination therapy with efinaconazole 10% solution and 1064 nm Nd:YAG laser for treatment of toenail onychomycosis.

BACKGROUND: Onychomycosis is a common but difficult to treat nail disorder. Treatment strategies thus far have included oral and topical antifungals, surgical treatment and recently lasers have emerged as a therapeutic modality. OBJECTIVE: The objective of this study was to assess whether efinaconazole together with laser would result in greater clinical and mycologic cure and lower rate of relapse compared to efinaconazole alone. METHODS: Thirty subjects were randomized to either self-apply efinaconazole 10% once daily for 48 weeks, or follow the same treatment plan but also receive six treatments with a 1064 nm Nd: YAG laser every 4 weeks. The primary endpoint was to assess the proportion of subjects who achieved complete cure at week 52. RESULTS: The combination therapy group showed significantly quicker mycological cure at the 48- and 52-week follow-up. CONCLUSION: Both efinaconazole and combination with laser were efficacious treatment, but the combination therapy leads to quicker resolution with fewer rate of relapse.

A prospective, randomized, double-blinded, split-face pilot study comparing Q-switched 1064-nm Nd:YAG versus 532-nm Nd:YAG laser for the treatment of solar lentigines.

Treating photoaging with laser technologies has increased in popularity due to their efficacy, minimal downtime, and side effects. New Q-Switched (QS) Nd:YAG lasers' frequency doubled with 532 nm wavelength can both target epidermal chromophores as well as stimulate collagen production. The objective of this study was to compare single-pulsed 1064-nm Nd:YAG with dual-pulsed 532-nm/1064-nm QS laser for reducing solar lentigines. Ten subjects with solar lentigines were enrolled in this prospective, randomized, double-blind, split-face study. Subjects received six laser treatments (half-face dual, half single) at 2-week intervals. Blinded investigator and subject assessments were conducted 1 month posttreatment to evaluate global skin improvement, safety, and patient satisfaction. Blinded investigator assessments showed statistically significant improvement in the dual-treated side. Patient satisfaction was also statistically significantly increased in the dual-treated side. In conclusion, dual laser treatment can result in superior and safe global improvement of photoaging.

Prospective, pilot evaluation of the performance of nanofractional radiofrequency for improvement of skin texture via skin resurfacing.

BACKGROUND: The latest generation of radiofrequency, nanofractional radiofrequency, allows the heat energy to be delivered through the use of pins or needles as electrodes, facilitating increased efficacy and reduced pain, downtime, and side effects. OBJECTIVE: The objective of this prospective pilot clinical study was to evaluate the efficacy of nanofractional radiofrequency in skin resurfacing. METHODS AND MATERIALS: Seventeen subjects were enrolled in the study, and each received three nanofractional radiofrequency (160-pin tip) treatments in the facial area at 3-week intervals. Follow-up visits were scheduled at 1 and 2 months after the final treatment. Clinical photography, patient, and investigator assessments were conducted during the treatment visits and follow-up. RESULTS: All subjects completed the study. At the 1- and 2-month follow-up, there was a moderate to significant improvement (2.6 and 3.5, respectively, P = .01) according to the investigator global esthetic improvement scale rating. Most subjects reported that they were satisfied or very satisfied with the outcome and level of comfort. CONCLUSION: Nanofractional radiofrequency is a safe and effective strategy for improving texture, tone, and skin laxity with high patient satisfaction and tolerable safety profile.

The Facial Adipose System: Its Role in Facial Aging and Approaches to Volume Restoration.

BACKGROUND: Volume loss in facial adipose tissue plays a critical role in the aesthetics of facial aging. Furthermore, the facial adipose system is a complex network of distinct compartments, and a detailed understanding of these compartments is essential for optimal facial volume restoration. OBJECTIVE: To review the facial adipose system, age-related changes, and the role of volume restoration products for facial rejuvenation. METHODS: Publications including deceased donors' dissection studies and more recent studies using computed tomography were reviewed to provide an up-to-date understanding of the facial adipose system anatomy and age-related changes. Current volume restoration treatment options including hyaluronic acid, calcium hydroxylapatite, and poly-L-lactic acid are discussed. RESULTS: Facial aging is associated with volume loss in superficial and deep adipose compartments, including those of the forehead, cheek, lip, chin, and jowl areas. Volume restoration products can be used to address the age-related changes of the facial adipose compartments. CONCLUSION: Understanding the complex network of facial adipose compartments and their age-related changes allows for the optimal use of injectable volume restoration products for facial rejuvenation that can be customized to the anatomical needs of each patient.

A randomized, controlled clinical study to investigate the safety and efficacy of acoustic wave therapy in body contouring.

BACKGROUND: There is an increased demand for the reduction of localized adipose tissue by noninvasive methods. OBJECTIVE: The objective of this study was to determine the safety and efficacy of noninvasive lipolysis of excess adiposities overlying the lateral thigh region using acoustic wave therapy (AWT). This study incorporates 2 mechanical waves with varying properties in the same session: radial and planar AWT. METHODS AND MATERIALS: The treatment was performed using AWT on the lateral thigh areas of 15 female patients. The study was performed using the planar and radial pulse handpieces, with 8 sessions performed within 4 weeks. Follow-up visits were performed 1, 4, and 12 weeks after the last treatment. RESULTS: Reduction in both thigh circumference and subcutaneous fat layer thickness, measured through ultrasound, was observed. CONCLUSION: This study demonstrates that AWT is safe and efficacious for the treatment of localized adiposities in the saddlebag area. However, the results obtained were not statistically significant. Larger studies will be needed to further access the effects of AWT on thigh circumference reduction. Furthermore, the authors also found an improvement in the appearance of both cellulite and skin firmness after the treatments.

Bipolar and multipolar radiofrequency.

BACKGROUND: The increased demand for anti-aging treatments over the past decade has fueled the development of multimodality devices. This allows for more efficacious treatment of dermal defects, excess adiposity, and skin laxity. Radiofrequency (RF) devices are constantly evolving and consequently adding multiple indications for their use. In this article, the authors focus on bipolar and multipolar RF modalities. OBJECTIVE: The objective was to review, summarize, and evaluate the key studies of procedural therapies using bipolar and multipolar RF technologies. METHODS: Studies selected for evaluation had clear statements of purpose, patient selection, follow-up evaluations, previous and concurrent medications, treatment parameters, methods for evaluating results, and adverse effects. All studies were complete and published in peer-reviewed journals. RESULTS AND CONCLUSION: With their unique mechanism of action, bipolar and multipolar RF devices remain versatile treatment options associated with minimal downtime and pain compared with monopolar RF and other nonablative modalities. Proper patient selection and education along with an experienced treating physician is crucial in achieving patient satisfaction and results. It is important that larger studies are conducted to provide data on upcoming devices. Review of the literature provides a starting point for physicians seeking to treat patients safely and effectively with newer devices.

Use of multispectral digital skin lesion analysis for evaluation of nevi in children.

OBJECTIVE: We determine if the use of Multispectral Digital Skin Lesion Analysis for the evaluation of nevi in children and possible detection of malignancies. EVIDENCE REVIEW: Evidence gathered from a pivotal study involving 1,383 patients with 1,831-pigmented lesions. The isolated use of the pediatric population within this study was used to determine the specificity and sensitivity of such a device with comparison to a dermatologists evaluation. FINDINGS: For all lesions from the assessed pediatric population the biopsy ratio was equivalent for the Multispectral Digital Skin Lesion Analysis device as for the dermatologists when performing as independent reviewers. Furthermore analyzed data suggests that dermatologists who incorporate the Multispectral Digital Skin Lesion Analysis device perform better than they would independently or if they were to follow the device blindly without incorporating their own judgment. CONCLUSION AND RELEVANCE: An approach that integrates automated imaging technology like the Multispectral Digital Skin Lesion Analysis device, along with another diagnostic aid, with the end result being cost-effective, easy to use by even non-experts and comforting for the pediatric patient is likely to compete to be the new gold standard in successful early diagnosis and management of melanoma.

Radiofrequency: an update on latest innovations.

As the aging population in our society continues to grow, new technologies and procedures promising a more youthful appearance are continuously sought. The utilization of radiofrequency technology remains a novel method for the treatment of many aesthetic and medical dermatological indications. Innovative applications are constantly identified, expanding treatment options for various patient concerns including aging of the hands, cellulite, non-invasive lipolysis, and postpartum skin laxity. Non-invasive treatments are ideal for busy patients seeking minimal recovery time and so called lunch-time procedures. Furthermore, new developments in treatment devices enhance efficacy while decreasing patient discomfort.

Home-based wrinkle reduction using a novel handheld multisource phase-controlled radiofrequency device.

BACKGROUND: In the last decade, energy-based aesthetic treatments, using light, radiofrequency (RF), and ultrasound, have gained scientific acceptance as safe and efficacious for non-invasive treatment for aesthetic skin disorders. The phase-controlled multisource radiofrequency technology (3DEEP™), which is based on the simultaneous use of multiple RF generators, was proven to allow significant pigment-independent dermal heating without pain or the need of epidermal cooling. This study was performed in order to evaluate the efficacy and safety of a new handheld device delivering multisource radiofrequency to the skin for wrinkle reduction and skin tightening in the home setting. PATIENTS AND METHODS: A total of 69 participants (age 54.3 years ± 8.09; age range 37-72 years) were enrolled in the study after meeting all inclusion/exclusion criteria (100%) and providing informed consent. Participants were provided with the tested device together with a user manual and treatment diary, to perform independent treatments at home for 4 weeks. The tested device, (Newa™, EndyMed Medical, Cesarea, Israel) emits 12 W of 1Mhz, RF energy through six electrodes arranged in a linear fashion. Independent control of RF polarity through each one of the 6 electrodes allows significant reduction of energy flow through the epidermis with increased dermal penetration. Participants were instructed to perform at least 5 treatments a week, for one month. Four follow-up visits were scheduled (once a week) during the period of independent treatments at home, following 4 weeks of home treatments, 1 month follow-up visit (1 month after treatment end) and at 3 months follow-up (3 months following treatment end). Analysis of pre-and post treatment images was conducted by three uninvolved physicians experienced with the Fitzpatrick Wrinkle and Elastosis Scale. Fitzpatrick Wrinkle and Elastosis score of each time point (4 weeks following home use treatments; 1 month follow-up, 3 months follow-up) was compared to baseline. Participants were asked a series of questions designed to explore usability concerns and level of satisfaction regarding the device use and subjective efficacy. RESULTS: Altogether, 62 subjects completed the study course and follow-up visits. No unexpected adverse effects were detected or reported throughout the independent treatment. All study participants did not experience any difficulties while operating the tested device for independent wrinkle reduction treatments. Photographic analysis of pre- and post-one month of independent home use treatments, and one and three months follow-up after end of treatment course, was conducted by three uninvolved board certified dermatologists. Analysis of results revealed improvement (downgrade of at least 1 score according to the Fitzpatrick scale) in 91.93%, 96.77%, and 98.39% of study subjects (according to the first, second, and third reviewer, respectively). Results were found to be statistically significant. The majority of study participants were very satisfied from the results of the independent treatment using the tested device for wrinkle reduction.

Aesthetic uses of the botulinum toxin.

The cosmetic use of botulinum toxin (BoNT) is the most common cosmetic procedure performed in the world today. Common adverse events seen in the aesthetic use of the BoNT include swelling, localized bruising, headaches, injection site discomfort, excessive muscle weakness, and unintended paresis of adjacent muscles. BoNT has a wide array of cosmetic uses, including treatment of glabellar lines, chemical browlift, forehead wrinkles, periorbital, and perioral lines. The future formulations and applications of BoNT type A will be plentiful, and are exciting to consider.