A Systematic Review Examining the Potential Adverse Effects of Microneedling.

BACKGROUND: Microneedling is a relatively safe therapeutic procedure used to treat many dermatological conditions, including acne vulgaris, alopecia, melasma and other pigmentary disorders, as well as to promote skin rejuvenation, rhytide reduction, and scar remodeling. Given its popularity among patients and increasing use in the clinic and at home, we aim to explain the adverse effects associated with microneedling procedures. OBJECTIVE: We reviewed the current literature describing microneedling and the complications that may accompany this therapeutic procedure. PubMed was searched to identify studies that involved microneedling procedures using the standard roller microneedling, stamp microneedling, pen-type microneedling, and/or fractional radiofrequency microneedling devices. The resulting publications included clinical trials, retrospective studies, and case reports, which were then thoroughly reviewed for description of potential or observed complications that arose secondary to the microneedling procedure. RESULTS: In this systematic review, a total of 51 articles were reviewed, which included 1,029 patients who received microneedling procedures for a variety of different skin conditions. Overall, this review found that microneedling, regardless of the specific device used, is a relatively safe procedure with minimal adverse effects, including, but not limited to, expected erythema, pain, edema, and temporary skin irritation. CONCLUSIONS: Microneedling has become an attractive treatment option for many patients with dermatological conditions. We advise that clinicians and patients be informed about the adverse side effects associated with microneedling so that the risk of preventable complications can be reduced or avoided.

An Assessment of Microneedling with Topical Growth Factors for Facial Skin Rejuvenation: A Randomized Controlled Trial.

BACKGROUND: The study of the use of growth factors in conjunction with microneedling is limited. It is hypothesized that the use of human growth factors will decrease recovery time by downregulating inflammation and will continue stimulating collagen synthesis initiated by microneedling. OBJECTIVE: We sought to evaluate the safety and efficacy of microneedling in combination with a novel human recombinant growth factor regenerative complex (PolyGF) for skin improvement. METHODS: This study was a randomized controlled trial evaluating changes in multiple skin parameters via provider, imaging, and patient self-assessments after four microneedling treatments, each spaced one month apart, with or without a novel growth factor. Twenty female patients aged 35 to 60 years were included. Evaluation parameters included fine lines and wrinkles, evenness of skin tone, skin clarity, age spots, skin smoothness, skin firmness, and hydration of skin via dermatologic Canfield VISIA (Fairfield, New Jersey) imaging, and patient self-assessment. RESULTS: Significant improvement in skin texture was reported to higher degrees for the PolyGF group by VISIA imaging assessments than in the control group. Subjective assessments in skin smoothness and hydration were significantly improved in the Poly GF groups. Hydration improvements were seen to a lesser degree in the control group. Improvements in firmness and texture were seen in both the PolyGF and control groups by subjective assessment. Significantly improved subjective assessments of skin tone and melanin index were reported only in the control groups. CONCLUSION: While microneedling improved skin in several parameters, the addition of the novel growth factor to microneedling helped improve skin texture and hydration to a higher degree. Further studies are needed to characterize the effects of growth factor serum in conjunction with microneedling.

Ultraviolet Light Gel Manicures: Is There a Risk of Skin Cancer on the Hands and Nails of Young Adults?

BACKGROUND: There appears to be limited research on whether the ultraviolet radiation used in nail lamps for gel manicures is increasing the incidence of skin cancer on the hands and nails of young adults. OBJECTIVE: We sought to assess evidence in the literature regarding the incidence of skin cancer on the hands and nails of young adults who receive gel manicures cured by ultraviolet light. METHODS: An extensive systematic literature review was conducted, focusing on patients aged 40 years or younger with a history of gel manicures diagnosed with nonmelanoma or melanoma skin cancers on the dorsum of their hands and nails. The Surveillance, Epidemiology and End-results Program (SEER) (SEER 9 and SEER 21) was chosen to analyze trends in the incidence of melanoma from 2007 to 2016. The SEER*Stat Client-serve Mode software was used to retrieve the incidence rates of melanoma of the skin among individuals aged 0 to 39 years from 1975 to 2016. RESULTS: There have been no cases reported of patients younger than the age of 40 years with a history of chronic gel manicures diagnosed with nonmelanoma skin cancer or melanoma on the dorsum of the hands or nail matrices. SEER revealed little to no change in the incidence of melanoma among patients under the age of 65 years. CONCLUSION: The literature is controversial regarding whether ultraviolet radiation from chronic gel manicures increases the risk of skin cancer on the hands and nails. A comprehensive literature search and the SEER database revealed that gel manicures have little to no carcinogenic risk.

Multiple Xanthogranulomas in a Teenager.

Juvenile xanthogranuloma (JXG) is a non-Langerhans cell histiocytosis that typically presents as a solitary lesion in infancy. Multiple lesions, especially in patients over one year of age, are rarely described in the literature. The authors report a case of a 17-year-old female who presented with multiple asymptomatic nodules and plaques. The diagnosis of xanthogranuloma was confirmed with histopathologic examination of foamy histiocytes and the characteristic Touton giant cells. The expected course of multiple JXG in older patients may differ from those presenting with a solitary lesion earlier in life.

Dermatologic Device Clearance Within the Food and Drug Administration's 510(k) Pathway.

BACKGROUND AND OBJECTIVES: Device innovation in dermatology is increasing. Medical devices identified as "substantially equivalent" to predicate ones by the United States Food and Drug Administration (FDA) may be exempt from premarket approval through the 510(k) pathway. The 510(k) pathway has been criticized for having less stringent clinical data requirements, and implications of dermatologic device clearance via this pathway are incompletely described. The objective of this study is to characterize dermatologic device clearance via the 510(k) pathway. STUDY DESIGN/MATERIALS AND METHODS: We performed a retrospective review of the FDA's 510(k) database between January 1, 1996 and December 31, 2018. Dermatologic devices were included based on product code and classified by the application. Approval pathways and decision characteristics were compared among dermatologic device categories. RESULTS: Of the 76,607 records screened, 4,637 met inclusion criteria. Laser/thermal devices comprised the largest category (64.2%), followed by wound (24.0%) and light-based devices (5.8%). The majority of 510(k) pathway submissions were traditional (89.2%) compared with alternative (10.8%) submission types (P = 0.003). Devices that were deemed substantially equivalent without limitations (98.5%) were the most common among all device categories. Rates of device clearance over the study period increased for all categories except laser/thermal devices. CONCLUSIONS: Dermatologic devices are increasingly cleared via the FDA's 510(k) pathway through "substantial equivalence" with minimal requirements for premarket clinical data. Lasers Surg. Med. © 2020 Wiley Periodicals, Inc.

A Protease-Activated Fluorescent Probe Allows Rapid Visualization of Keratinocyte Carcinoma during Excision.

Keratinocyte carcinomas, including basal and squamous cell carcinomas, are the most common human cancers worldwide. While 75% of all keratinocyte carcinoma (4 million annual cases in the United States) are treated with conventional excision, this surgical modality has much lower cure rates than Mohs micrographic surgery, likely due to the bread-loaf histopathologic assessment that visualizes <1% of the tissue margins. A quenched protease-activated fluorescent probe 6qcNIR, which produces a signal only in the protease-rich tumor microenvironment, was topically applied to 90 specimens ex vivo immediately following excision. "Puzzle-fit" analysis was used to correlate the fluorescent images with histology. Probe-dependent fluorescent images correlated with cancer determined by conventional histology. Point-of-care fluorescent detection of skin cancer had a clinically relevant sensitivity of 0.73 and corresponding specificity of 0.88. Importantly, clinicians were effectively trained to read fluorescent images within 15 minutes with reliability and confidence, resulting in sensitivities of 62%-78% and specificities of 92%-97%. Fluorescent imaging using 6qcNIR allows 100% tumor margin assessment by generating en face images that correlate with histology and may be used to overcome the limitations of conventional bread-loaf histology. The utility of 6qcNIR was validated in a busy real-world clinical setting, and clinicians were trained to effectively read fluorescent margins with a short guided instruction, highlighting clinical adaptability. When used in conventional excision, this approach may result in higher cure rates at a lower cost by allowing same-day reexcision when needed, reducing patient anxiety and improving compliance by expediting postsurgical specimen assessment. SIGNIFICANCE: A fluorescent-probe-tumor-visualization platform was developed and validated in human keratinocyte carcinoma excision specimens that may provide simple, rapid, and global assessment of margins during skin cancer excision, allowing same-day reexcision when needed.

An Analysis of Marketing Trends for the Approval of Cryolipolysis Devices by the United States Food and Drug Administration.

Introduction: Cryolipolysis is a noninvasive technique that involves the application of cooling for localized fat reduction. In recent years, cryolipolysis has been increasingly favored for its limited side effects compared to more invasive methods. Methods: Records from a public United States Food and Drug Administration (FDA) database for premarket approval of cryolipolysis devices approved between January 1, 2000 and July 15, 2018 were reviewed. Results: Eleven devices received 510(k) premarket approval, with an increasing number of devices available since 2012. In addition, product indications have recently been expanded for use in patients with body mass index (BMI) values of up to 43kg/m2. Conclusion: The number of approved cryolipolysis devices has increased, with more companies exploring the technology's growth potential in the market. Furthermore, use in patients with higher body mass index values is now permitted and expanding; however, indications are not well studied, and these marketed devices might misinform consumers and distort clinical expectations. Additional research to delineate specific practice guidelines for cryolipolysis is necessary.

Over-the-counter light therapy for acne: a cross-sectional retrospective analysis.

Acne vulgaris affects a large portion of the population and drives many patients to seek over-the-counter (OTC) treatments. Light-emitting diode (LED) therapy has recently emerged as a potential therapeutic option for inflammatory acne. We used the U.S. Food and Drug Administration (FDA) 510(k) premarket submission database to assess the growth in OTC LED therapy devices for treatment of acne. We also used Google Trends data in searches for "acne light therapy mask" to characterize growth in consumer interest in these devices. Overall, 35 LED devices received pre-market approval from 2000 to 2018, with a peak in approvals in 2016. Similarly, there was a dramatic increase in public interest in these devices in 2016. Only two devices were associated with company-approved trials. The current regulatory process requires little evidence to substantiate specified uses and a better understanding of practice guidelines and the efficacy of this treatment modality is required.

Shedding light on the FDA's 510(k) approvals process: low-level laser therapy devices used in the treatment of androgenetic alopecia.

Introduction: Low-level laser therapy has demonstrated superior efficacy relative to other nonsurgical treatment options for the treatment of androgenetic alopecia. Methods: Records from a public U.S. FDA database for premarket approval of low-level laser therapy devices approved between January 1 2000 and July 15 2018 were reviewed. Results: 47 devices received 510(k) premarket approval, with an increasing number of devices available since 2007. More options are now available and product indications have expanded for use in a wider audience, including both men and women. Discussion: Growing recognition of lasers has led to an increasing number of devices available as well as innovative options in terms of design and convenience. In the past few years, these devices have adopted broader indications for use in both men and women. However, marketed indications have not been adequately explored and current devices on the market have the potential to mislead consumers.

Reflectance Confocal Microscopy Features of Focal Dermal Mucinosis Differ from Those Described for Basal Cell Carcinoma: Report of Two Cases.

The purpose of this study was to describe the reflectance confocal microscopy (RCM) features of focal dermal mucinosis (FDM). The entity clinically and dermatoscopically mimics other diagnostic entities, most notably nonpigmented basal cell carcinoma. We describe two cases that highlight the dermatoscopic, RCM and histopathological attributes of FDM. RCM features such as dermal foci of dense collagen bundles oriented in the same direction, foci of haphazardly oriented thin collagen fibers separated by dark structureless areas and the absence of dark silhouettes and tumor islands are clues for FDM diagnosis. The FDM cases described here present consistent and particular RCM findings that appear to correlate well with the histopathological features of FDM. Therefore, RCM is a promising technology in diagnosing skin lesions and it use can avoid invasive procedures.

Resident Rounds: Part III--Case Report: Metastatic Multiple Myeloma.

We report a case of cutaneous plasmacytomas developing in a patient with a 7-month history of progressive multiple myeloma refractory to bortezomib and combination chemotherapy. When involving the skin, plasmacytomas typically arise in the setting of multiple myeloma as contiguous extensions from underlying bony disease. More rarely, cutaneous plasmacytomas develop from hematologic metastases in patients with a high systemic plasma cell tumor burden. In our patient, the presence of cutaneous plasmacytomas involving two distinct sites, and malignant plasma cells within the dermis without infiltration into the subcutaneous fat, suggest a diagnosis of metastatic multiple myeloma to the skin. Metastatic multiple myeloma to the skin portends a poor prognosis, and treatment should be aimed at the underlying systemic disease.