Treatment with synchronized radiofrequency and facial muscle stimulation: Histologic analysis of human skin for changes in collagen and elastin fibers.

BACKGROUND: Skin's exposure to intrinsic and extrinsic factors causes age-related changes, leading to a lower amount of dermal collagen and elastin. AIM: This study investigated the effects of a novel facial muscle stimulation technology combined with radiofrequency (RF) heating on dermal collagen and elastin content for the treatment of facial wrinkles and skin laxity. METHODS: The active group subjects (N = 6) received four 20-min facial treatments with simultaneous RF and facial muscle stimulation, once weekly. The control subject (N = 1) was untreated. Skin biopsies obtained at baseline, 1-month and 3-month follow-up were evaluated histologically to determine collagen and elastin fibers content. A group of independent aestheticians evaluated facial skin appearance and wrinkle severity. Patient safety was followed. RESULTS: In the active group, collagen-occupied area reached 11.91 ± 1.80 × 106 µm2 (+25.32%, p < 0.05) and 12.35 ± 1.44 × 105 µm2 (+30.00%, p < 0.05) at 1-month and 3-month follow-up visits. Elastin-occupied area at 1-month and 3-month follow-up was 1.64 ± 0.14 × 105 µm2 (+67.23%, p < 0.05), and 1.99 ± 0.21 × 105 µm2 (+102.80%, p < 0.05). In the control group, there was no significant difference (p > 0.05) in collagen and elastin fibers. Active group wrinkle scores decreased from 5 (moderate, class II) to 3 (mild, class I). All subjects, except the control, improved in appearance posttreatment. No adverse events or side effects occurred. CONCLUSION: Decreased dermal collagen and elastin levels contributes to a gradual decline in skin elasticity, leading to facial wrinkles and unfirm skin. Study results showed noticeable improvement in facial appearance and increased dermal collagen and elastin content subsequent to simultaneous, noninvasive RF, and facial muscle stimulation treatments.

Induction of fat apoptosis by a combination of synchronized radiofrequency and HIFEM technology: Human histology study.

PURPOSE: With the growing demand for more effective fat reduction techniques, a combination of synchronized radiofrequency (RF) and HIFEM has been introduced. Preceding studies evidenced the ability of RF+HIFEM to maintain the fat tissue temperature at the levels necessary for adipocyte apoptosis while documenting the induced changes to the fat tissue during the several weeks after the treatment. This study aims to demonstrate the induction of apoptosis by RF+HIFEM technology in the early stages through the assessment of caspase-3 protein, one of the apoptosis-executing proteases. DESIGN: In this two-arm, single-center, randomized trial, nine human subjects were enrolled and assigned into two groups, either the active group (N = 6) treated with both RF+HIFEM set at the highest tolerated levels or the sham group (N = 3) treated with 5% of the maximum RF+HIFEM power, serving as a control. All patients were scheduled to undergo one treatment visit of the abdominal area, two follow-up visits at 8 and 24 h, and one safety visit 7 days after the treatment. A punch biopsy (5 mm in diameter, approximately 10 mm in depth) was obtained from the abdominal area at the baseline and consecutive follow-up visits. Samples were fixed, and cut into 5 µm thick slices, and immunohistochemical staining was used to visualize the Caspase-3, revealing the adipocyte nuclei where apoptosis processes are in progress. FINDINGS: Documented findings suggest that the temperature threshold of 43-45°C is required to initiate fat apoptosis and consequent reduction in adipocyte number was achieved during the combined treatment with RF+HIFEM. The active group showed an elevated ratio of positively stained nuclei versus all adipocyte nuclei found on the evaluated slices-referred to as the apoptotic index (AI). The AI significantly (p < 0.001) increased at both 8 h (47.01 ± 10.56%) and 24 h (43.58 ± 6.35%) posttreatment. The Sham group showed no significant change in the AI (p > 0.05). No adverse events or side effects related to the treatments were observed. SUMMARY: This study supports previously published evidence on fat reduction after RF+HIFEM treatment, documenting the safe initiation of adipocyte programmed cell death posttreatment.

Assessment of adverse events for a home-use intense pulsed light hair removal device using postmarketing surveillance.

BACKGROUND AND OBJECTIVES: Home-use intense pulsed light (IPL) hair removal devices are convenient for consumers. Consumer safety associated with home-use IPL devices, however, remains a subject of interest. In this descriptive analysis, we assessed the most commonly reported adverse events (AEs) for a home-use IPL device from postmarketing surveillance and qualitatively compared these with AEs from clinical studies and medical device reports of home-use IPL treatments. MATERIALS AND METHODS: For this analysis of voluntary reports, we queried a distributor's postmarketing database for IPL devices for the period beginning January 1, 2016, to December 31, 2021. All sources of comments, for example, phone, e-mail, company-sponsored web sites, were included in the analysis. AE data were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) terminology. Also, we conducted a PubMed search to identify AE profiles from existing literature on home-use IPL devices and we searched the Manufacturer and User Facility Device Experience (MAUDE) database for reports on home-use IPL devices. These results were qualitatively compared to the data in the postmarketing surveillance database. RESULTS: A total of 1692 cases involving IPL were identified from voluntary reports of AEs between 2016 and 2021. The shipment-adjusted reporting rate for AE cases (number of AE cases/100,000 shipped IPL devices) was 67/100,000 during this 6-year period. The most commonly reported AEs were pain of skin 27.8% (470/1692), "thermal burn" 18.7% (316/1692), and erythema 16.0% (271/1692). Among the top 25 AEs reported, no unexpected health events were observed. The reported AEs were qualitatively similar to the pattern seen in clinical studies and the MAUDE database associated with such home-use IPL treatments. CONCLUSION: This is the first such report documenting AEs for home-use IPL hair removal from a postmarketing surveillance program. These data are supportive of the safety of such home-use low-fluence IPL technology.

Oxymetazoline and Energy-Based Therapy in Patients with Rosacea: Evaluation of the Safety and Tolerability in an Open-Label, Interventional Study.

BACKGROUND AND OBJECTIVES: The objectives of this study were to evaluate the safety, tolerability, and efficacy of oxymetazoline hydrochloride cream, 1% (oxymetazoline) when used as an adjunctive treatment with energy-based therapy for patients with moderate to severe facial erythema associated with rosacea. STUDY DESIGN/MATERIALS AND METHODS: In this Phase 4, multicenter, interventional, open-label study, eligible patients received one of four energy-based therapies (potassium titanyl phosphate laser, intense pulsed light therapy, pulsed-dye laser Vbeam Perfecta, or pulsed-dye laser Cynergy) on day 1 and day 29 and once-daily application of oxymetazoline on days 3 through 27 and days 31 through 56. Improvement from baseline in Clinician Erythema Assessment (CEA) score, patient satisfaction measures, incidence of treatment-emergent adverse events (TEAEs), and worsening from baseline on dermal tolerability assessments and the Clinician Telangiectasia Assessment (CTA) were assessed. Data were summarized using descriptive statistics. RESULTS: A total of 46 patients (mean age, 51.1 years; 78.3% female) enrolled in this study. Similar numbers of patients received each of the energy-based therapies in addition to oxymetazoline. All patients demonstrated an improvement from baseline in CEA during the study with 39 of 43 evaluable patients (90.7%) demonstrating an improvement 6 hours posttreatment on day 56. Most patients were satisfied or very satisfied with treatment at the end of the study. All TEAEs were mild or moderate in severity. Some patients experienced worsening in dermal tolerability assessment symptoms (range: 4-21 patients; 8.7-45.7%). Worsening in CEA and CTA were each reported by three patients (6.5%) at any time during the study. CONCLUSIONS: Treatment with oxymetazoline as adjunctive therapy with energy-based therapy was safe, well tolerated, and reduced facial erythema in patients with moderate to severe persistent facial erythema associated with rosacea. Lasers Surg. Med. © 2020 The Authors. Lasers in Surgery and Medicine published by Wiley Periodicals LLC.

Pre-/postprocedure measures for laser/energy treatments: A survey.

BACKGROUND: Laser and energy-based devices may be used for many cutaneous indications, including facial resurfacing, improving skin conditions, and reducing signs of photoaging. Currently, no consensus papers or guidelines exist concerning peri-operative agents and specifically their use for laser skin resurfacing and their potential/possible role in prevention or treatment of side effects. AIM: To explore current practice using laser and energy devices, a survey was developed to identify the trends in pre- and postprocedural treatment measures. METHODS: The survey was sent out digitally to 300 randomly selected US dermatologist and plastic surgeon physicians practicing medical esthetics using laser and other energy devices treatment for facial rejuvenation. The survey gathered information on demographics, types of devices used in the clinic and pre-/postprocedural measures for facial laser, and other energy-based devices treatment. RESULTS: The survey was active from June 15, to July 15, 2018, and fifty-eight dermatologists and plastic surgeons completed the survey (19.3% response rate, 58/300). The results showed inconsistency in skin preparation strategies and postprocedure wound care. The majority of survey participants (55/58 [96%]) reported prophylactic oral antiviral use pre- and post-treatment; however, there was inconsistency about when to start and when to stop the use. A similar inconsistency existed in the recommended period of post-treatment sun protection before and after treatment. CONCLUSION: The results of the survey confirmed the lack of consistency in the types and duration of pre- and postprocedural measures-emphasizing the need for evidence-based recommendations to optimize outcomes, prevent infection, enhance comfort, and reduce downtime.

Clinically Significant Lab Errors due to Vitamin B7 (Biotin) Supplementation: A Case Report Following a Recent FDA Warning.

A 67-year-old female with a past medical history of multiple endocrine issues presented for follow-up subsequent to abnormal routine blood testing results. These included low thyroid stimulating hormone (TSH), low parathyroid hormone (PTH), and mildly elevated calcium levels. The presence of hypercalcemia and accompanying low PTH raised the concern for malignancy, while the depressed TSH indicated hyperthyroidism. Review of the patient's medications revealed daily supplementation with 5 mg of vitamin B7 (biotin). The biotin was discontinued after suspecting the supplement was interfering with the patient's lab values. The labs were repeated one month later. The results showed normalized TSH, PTH, and calcium levels. The increasingly wide-spread use of biotin supplementation and the use of biotin as a component in many of the most common clinical assays has led to a trend of lab errors due to biotin interference. While some physicians are aware of the possibility of skewed results, steps need to be taken to prevent misdiagnosis. This includes ensuring that information about this issue is more widely disseminated, accurately accounting for a patient's supplement use, reconciling proper clinical correlation with lab results, and promptly reporting when biotin is determined to be the cause of otherwise unexplained lab errors.

Sorafenib in Hepatopulmonary Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

The tyrosine kinase inhibitor sorafenib improves hepatopulmonary syndrome (HPS) in an experimental model. However, the efficacy and adverse effect profile in patients with HPS are unknown. We aimed to determine the effect of sorafenib on the alveolar-arterial oxygen gradient (AaPO2 ) at 3 months in patients with HPS. We performed a randomized, double-blind, placebo-controlled parallel trial of sorafenib in patients with HPS at 7 centers. A total of 28 patients with HPS were randomized to sorafenib 400 mg by mouth daily or a matching placebo in a 1:1 ratio. We found no statistically significant difference in the median change in AaPO2 from baseline to 12 weeks between the patients allocated to sorafenib (4.5 mm Hg; IQR, -3.8 to 7.0 mm Hg) and those allocated to placebo (-2.4 mm Hg; IQR, -4.8 to 8.2 mm Hg; P = 0.70). There was also no difference between the groups in terms of degree of intrapulmonary shunting by contrast echocardiography. Sorafenib significantly reduced circulating levels of angiogenic markers, including vascular endothelial growth factor receptors (P < 0.01) and TIE2-expressing M2 monocytes (P = 0.03), but it reduced the mental component scores of the Short Form 36 (P = 0.04), indicating a worse quality of life. In conclusion, sorafenib did not change the AaPO2 or other disease markers at 3 months in patients with HPS. Alternative antiangiogenic therapies or treatments targeting other pathways should be investigated.

Voigt-Futcher pigmentary demarcation lines.

Pigmentary demarcation lines (PDLs) are physiological abrupt transitions between hyperpigmented and lighter skin, a common and sometimes troubling feature of normal skin. They are seen in a majority of dark-complexioned women and a substantial percentage of light-complexioned ones too. We review this salient finding and approaches to its management.

Use of a novel 589-nm solid-state laser for treatment of facial erythema.

OBJECTIVE: To evaluate the efficacy and safety associated with use of a 589-nm solid-state laser for treatment of facial erythema. METHODS: A prospective, IRB-approved study was conducted. Participants who were interested in treatment for facial erythema were recruited. They received four monthly treatments with the 589-nm laser. Erythema of the right and left face was graded on a scale of 0-4, 4 being most severe, by both investigators and participants prior to each treatment and at follow-up. Safety was assessed by any reported side effects. RESULTS: Twenty-four participants enrolled in the study, 16 women (67%) and 8 men (33%), with an average age of 51.1 years. Investigator grades showed a statistically significant improvement in erythema of 31% for both the right and left face. Participant grades showed a statistically significant improvement in erythema of 23.2% for the right face and 22.8% for the left face. Side effects were limited to transient erythema posttreatment. CONCLUSION: A 589-nm solid-state laser achieved a modest improvement in facial erythema when evaluating results 1 month after four monthly treatments. No major safety issues were reported.

Differentiating Nonpermanent Injectable Fillers: Prevention and Treatment of Filler Complications.

Though the incidence of complications and adverse events with dermatological fillers is inherently low, practitioners should be well versed in both prevention of filler complications and the treatment algorithms for addressing "granulomas," nodules, infection, and vascular compromise. Appropriate preventative measures, coupled with timely and effective treatment, are critically important for patient safety and satisfaction. In addition to the preventive measures and treatment algorithms outlined here, the authors emphasize that the broad classification and treatment of nodules as "granulomas" is likely to lead to ineffective treatment, or worse, unnecessary exposure to incorrect treatment. In practice, nodules are classified and treated based on clinical manifestation (eg, late vs early or noninflammatory vs inflammatory) rather than on histology. Indeed, classification of a nodule as a granuloma requires a histological examination, rarely available (or necessary) in clinical practice to guide treatment. Thus, the apparent inflammatory nature of the nodule and the time of onset should drive treatment approach. The treatment algorithms presented here are based on these clinically meaningful parameters.

Current treatments of acne: Medications, lights, lasers, and a novel 650-µs 1064-nm Nd: YAG laser.

The treatment of acne, especially severe acne, remains a challenge to dermatologists. Therapies include retinoids, antibiotics, hormones, lights, lasers, and various combinations of these modalities. Acne is currently considered a chronic rather than an adolescent condition. The appropriate treatment depends on the patient and the severity of disease. The purpose of this study was to review current therapies for acne of all severities and to introduce the 650-µs 1064-nm laser for the treatment of acne.

IPL vs PDL in treatment of facial erythema: A split-face study.

BACKGROUND: Lasers and noncoherent intense pulse light sources effectively treat vascular lesions. Intense pulsed light (IPL), a nonablative treatment for photorejuvenation, uses a flashlamp which emits noncoherent light between 400 and 1400 nm. The light may be filtered to target a specific chromophore. The pulsed dye laser (PDL), at 595 nm, has been the historical standard of care in the treatment of facial erythema. We sought to determine whether IPL may be used in lieu of PDL in reducing facial erythema. OBJECTIVES: To determine whether IPL may be used to treat facial erythema with equal efficacy as PDL used at nonpurpuric settings. METHODS: Prospective investigation of a cohort of 15 subjects with unwanted bilateral facial erythema. Subjects presented for two treatments with an IPL (BBL™ BroadBand Light; Sciton, Palo Alto, CA) to one half of the face and PDL (Cynergy™; Cynosure, Westford, MA) to the other half. RESULTS: Patients with facial erythema may be successfully treated with IPL or PDL. CONCLUSIONS: Intense pulsed light and pulsed dye laser with nonpurpuric settings were equally effective in reducing facial erythema.