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BACKGROUND AND OBJECTIVE: It is essential for physicians to be fully informed regarding adverse events and malfunctions associated with medical devices that occur in routine practice. There is limited information on this important issue in the medical literature, and it is mostly based on initial studies and case reports. More advanced knowledge regarding device adverse events is necessary to guide physicians towards providing safe treatments. The FDA requires that manufacturers and device users submit medical device reports (MDRs) for suspected injuries from device use or malfunction. The database of MDRs, entitled Manufacturer and User Facility Device Experience (MAUDE) enables the FDA to monitor device performance and identify potential safety issues. STUDY DESIGN/MATERIALS AND METHODS: We employed the following search strategy to identify reported adverse events. We searched the MAUDE electronic database on the FDA website in December 2013: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm We collected all reported cases between 1991 and December 2013. The search terms utilized included a comprehensive list of device manufacturers, specific product names, and the wavelengths/technology of the devices used in the field of dermatology. RESULTS: Our search yielded 1257 MDRs. Forty-five MDRs were excluded due to insufficient data. The data is broken down into the adverse events observed, such as, but not limited to: blistering, burns, scarring, dyschromia, fat loss, and nerve palsy. The MDRs describe the adverse event and attempt to determine if it was related to device malfunction versus operator error. Radiofrequency devices, diode lasers, and intense pulsed light devices were the most commonly reported devices related to injuries. CONCLUSION: 1257 MDRs, from a myriad of devices used in dermatology, have been reported to the FDA as of December 2013. Despite the underreporting of adverse events, the MAUDE database is an untapped resource of post-market surveillance of medical devices. The database can offer additional information, which combined with the initial device studies and published case reports from our colleagues, will help raise awareness and improve patient safety.

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BACKGROUND: Despite being the gold standard for lower extremity reticular vein treatment, few studies have yet evaluated foam sclerotherapy for hand veins. OBJECTIVE: This retrospective study evaluates the safety and efficacy of foam sclerotherapy for reticular veins of the dorsal hands. METHODS: A telephone-based questionnaire was used for patient self-assessment of overall improvement, satisfaction, prevalence of adverse events, and willingness for repeat treatment after foam sclerotherapy with sodium tetradecyl sulfate (STS). All patients had been treated with foam STS of 0.25% to 1.0% concentration using room air. RESULTS: Twenty-one of 45 patients were successfully contacted, with a total of 54 treatment sessions performed on 38 hands. Overall, patients reported scores of 2.55 ± 0.56 for overall improvement (0 = none, 1= mild, 2 = moderate, and 3 = complete resolution) and 1.79 ± 0.41 for satisfaction with results (0 = not satisfied at all, 1 = mildly satisfied, and 2 = very satisfied), with few significant treatment-related adverse events. Most patients stated they would undergo another treatment if needed. CONCLUSION: This single-center experience found that foam sclerotherapy with STS is a safe and effective treatment for reticular veins of the dorsal hands with excellent long-term patient satisfaction.

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BACKGROUND & OBJECTIVE: Laser hair removal has become an increasingly popular method to remove unwanted or excessive hair. We have assessed the relative efficacy and discomfort associated with competing hair removal techniques, namely a high average power 810 nm diode laser using an "in-motion" technique with a market-leading 810 nm device with a single-pass vacuum-assisted technique. This study has determined the long-term (6-12 months) hair reduction efficacy and the relative pain induction intensities of these devices. STUDY DESIGN/MATERIALS AND METHODS: Prospective, randomized, side-by-side comparison of either the legs or axillae was performed comparing the Soprano XL 810 nm diode in super hair removal (SHR) mode (Alma Lasers, Buffalo Grove, IL) hereafter known as the "in-motion" device vs. the LightSheer Duet 810 nm diode laser (Lumenis) hereafter known as the "single pass" device. Five laser treatments were performed 6 to 8 weeks apart with 1, 6, and 12 months follow-ups for hair counts. Pain was assessed in a subjective manner by the patients on a 10-point grading scale. Hair count analysis was performed in a blinded fashion. RESULTS: There was a 33.5% (SD 46.8%) and 40.7% (SD 41.8%) reduction in hair counts at 6 months for the single pass and in-motion devices respectively (P = 0.2879). The average pain rating for the single pass treatment (mean 3.6, 95% CI: 2.8 to 4.5) was significantly (P = 0.0007) greater than the in-motion treatment (mean 2.7, 95% CI 1.8 to 3.5). CONCLUSIONS: This data supports the hypothesis that using diode lasers at low fluences and high average power with a multiple pass in-motion technique is an effective method for hair removal, with less pain and discomfort, while maintaining good efficacy. The 6 month results were maintained at 12 month for both devices.

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BACKGROUND: Pulsed dye laser (PDL) is the gold standard for treatment of port-wine stain (PWS) birthmarks but multiple treatments are required and complete resolution is often not achieved. Posttreatment vessel recurrence is thought to be a factor that limits efficacy of PDL treatment of PWS. Imiquimod 5% cream is an immunomodulator with antiangiogenic effects. OBJECTIVE: We sought to determine if application of imiquimod 5% cream after PDL improves treatment outcome. METHODS: Healthy individuals with PWS (n = 24) were treated with PDL and then randomized to apply posttreatment placebo or imiquimod 5% cream for 8 weeks. Chromameter measurements (Commission Internationale de l'Eclairage L∗a∗b∗ colorspace) for 57 PWS sites (multiple sites per patient) were taken at baseline and compared with measurements taken 8 weeks posttreatment. The Δa∗ (change in erythema) and ΔE (difference in color between normal-appearing skin and PWS skin) were measured to quantify treatment outcome. RESULTS: Two patients developed minor skin irritation. Other adverse effects were not noted. Average ∆a∗ was 0.43 for PDL + placebo sites (n = 25) and 1.27 for PDL + imiquimod sites (n = 32) (P value = .0294) indicating a greater reduction in erythema with imiquimod. Average ∆E was 2.59 for PDL + placebo and 4.08 for PDL + imiquimod (P value = .0363), again indicating a greater color improvement with imiquimod. LIMITATIONS: Effects were evaluated after a single treatment and duration of effect is unknown. CONCLUSION: Combined selective photothermolysis and antiangiogenic therapy may enhance PWS treatment efficacy.

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BACKGROUND: Many patients with rosacea cannot tolerate extended treatment periods with topical agents because their skin sensitivity is often increased. OBJECTIVE: To determine the long-term efficacy and tolerability of a new moisturizing lotion for improving the signs and symptoms of mild-to-moderate rosacea. METHODS: In a 48-week, open-label study, a moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK-124 (0.125%, Pyratine-XR, Senetek PLC, Napa, CA) was applied twice daily by 18 subjects with mild-to-moderate rosacea. Clinical improvements were assessed by the treating physician. Skin barrier function was measured by transepidermal water loss after treatment. Tolerability and cosmetic outcome were evaluated by subjects. RESULTS: Subjects experienced a mean 44 percent reduction in erythema severity and a mean 89 percent reduction in inflammatory lesion count at week 48. Reductions were significant (P < 0.05) in both erythema and lesions at weeks 24, 36 and 48. Statistically significant (P < or = 0.05) improvements in telangiectasias, transepidermal water loss and dryness were noted. Overall clinical improvement was observed in 81 percent of subjects and the investigator's global assessment steadily improved throughout the study. Treatments were well-tolerated and cosmetically acceptable. Treatment-induced skin irritation was not observed. CONCLUSION: The new moisturizing lotion containing furfuryl tetrahydropyranyladenine as PRK 124 is efficacious, does not irritate skin, and is well tolerated for at least 48 weeks.

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BACKGROUND AND OBJECTIVE: Recently, there has been much debate regarding the long-term efficacy of fractional resurfacing devices. While pulsed CO(2) laser resurfacing is considered a highly effective treatment, fractionated resurfacing is a newer modality and its long-term efficacy has yet to be assessed. We report the long-term outcomes of subjects previously treated with fractional CO(2) resurfacing for photodamaged skin and acne scars. STUDY DESIGN/MATERIALS AND METHODS: Ten subjects from our previous studies who received fractional resurfacing for the treatment of acne scarring and photodamage returned for long-term follow-up visits at 1 and 2 years, respectively. Investigators graded maintenance of improvement on a quartile scale based on clinical photography. RESULTS: Subjects maintained 74% of their overall improvement at their long-term visits compared to 3-month follow-up visits. While clinical improvement was maintained long-term, the results were not as remarkable as those seen at 3-month visits. The authors speculate that results seen at 3 months may be enhanced by persistent inflammatory changes, as evidenced by heat shock protein 47 activity and ongoing collagen remodeling seen in previous histologic studies. Relaxation of tightening is to be expected with any procedure along with the natural progression of aging. However, patient satisfaction was upheld long-term. CONCLUSION: Fractional CO(2) laser resurfacing does have long-term efficacy and persistence of improvement of acne scarring and photodamage compared to baseline. However, additional treatments may be necessary to enhance long-term results.

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There is an increasing demand for minimally-invasive cosmetic procedures to arrest the aging process. Botulinum toxin type A injections are the most commonly used nonsurgical cosmetic procedures in the United States. There has been research spanning over two decades dedicated to safety, efficacy, dosing, and complications of botulinum toxin type A. There are now two Food and Drug Administration (FDA) approved botulinum toxin type A options in the United States: Botox(®) and Dysport(™), with new advances being made in the field.

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BACKGROUND: A phase 2 trial was conducted to evaluate the efficacy of a topical antiviral, sorivudine, as an adjuvant to valacyclovir for the treatment of acute herpes zoster. METHODS: In this randomized, placebo-controlled, double-blind trial, 25 patients were treated with either sorivudine or placebo cream. All patients began 7 days of valacyclovir treatment on day 3. Zoster lesion swab samples and samples of peripheral blood mononuclear cells were collected periodically throughout the study and were analyzed for varicella-zoster virus (VZV) DNA by use of both qualitative and real-time polymerase chain reaction. Serum samples collected periodically throughout the study were analyzed for VZV DNA by use of real-time polymerase chain reaction. RESULTS: VZV DNA was detected in all 3 sample types, and the number of viral copies correlated with the progression of herpes zoster. No statistically significant differences were seen between the placebo- and sorivudine-treated groups with respect to clinical characteristics or laboratory test results. CONCLUSION: The detection of VZV DNA in the serum and peripheral blood mononuclear cells of all 25 zoster patients documents that viremia is a common manifestation of herpes zoster. Sorivudine cream appears to be a safe and well-tolerated adjuvant therapy; however, further phase 2 studies are needed to determine its clinical efficacy for the treatment of herpes zoster. Trials registration. ClinicalTrials.gov identifier: NCT00652184.

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Herpes simplex virus (HSV) infection is a highly prevalent condition responsible for significant morbidity and occasional mortality each year. Approximately half of all patients infected by HSV will experience at least one recurrence in their lifetime. For these recurrences, traditional therapy has included both suppressive and episodic treatment with nucleoside analogs. In regards to episodic treatment, 2- to 5-day oral regimens are best studied and most commonly reported. As with any medical condition having a well-understood mechanism of action and targeted treatment, therapeutic intervention is only as effective as allowed by patient compliance. Based on these concerns, recent studies have focused on shorter, less complicated, and more affordable options. This review delineates the evidence for single-day treatments of orolabial and genital herpes. Randomized, double-blind studies of both valacyclovir and famciclovir as single-day episodic therapy for HSV have been reported in the literature. Although no head-to-head studies between the drugs have been performed, both regimens produced significant improvement in healing time and symptom resolution over placebo. Single-day therapy for HSV infection is appealing for multiple reasons. First, it simplifies the regimen, increasing likelihood of patient compliance. Additionally, it allows complete delivery of the medication at the onset of symptoms, when viral replication is highest and intervention has greatest effect. Lastly, the reduced number of pills necessary for single versus multiple day therapy decreases the overall cost of treatment per episode, an important factor in modern-day healthcare.

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This review focuses on Epstein-Barr virus (EBV) infection, diagnosis, and current treatment, with emphasis on EBV-associated mucocutaneous manifestations in primary infections, acute EBV-associated syndromes, chronic infections, lymphoproliferative disorders, and lymphomas. In primary infection, EBV infects B cells and can cause mucocutaneous manifestations in infectious mononucleosis or acute EBV-associated syndromes such as Gianotti-Crosti syndrome and hemophagocytic syndrome. EBV then persists in the majority of humans generally without causing disease. In some cases, however, latent EBV infection may result in diseases such as hydroa vacciniforme, hypersensitivity to mosquito bites, and lymphoproliferative disorders such as plasmablastic lymphoma, oral hairy leukoplakia, and post-transplant lymphoproliferative disorders, particularly in immunocompromised patients. Latent EBV infection has also been implicated in a variety of malignant conditions such as Burkitt lymphoma, Hodgkin lymphoma, nasopharyngeal carcinoma, and Kikuchi histocytic necrotizing lymphadenitis. Since the immune system is critical in preventing the progression of EBV disease, the immunologic status of the patient plays a crucial role in the subsequent development of pathologies.

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BACKGROUND: Psoriasis is a chronic and disabling disease affecting patients' quality of life. OBJECTIVES: Over the past decade, there has been significant growth in the knowledge of the proinflammatory pathways involved in psoriasis, including the role of increased levels of TNF. This knowledge has led to the increased use of biologic therapy, with such drugs as etanercept, a soluble TNF receptor fusion protein, aimed at inhibiting the actions of TNF. The goal of biologic generation is to provide selectively targeted therapy with fewer adverse events than traditional therapies. METHODS: Etanercept has been studied extensively and Phase III studies have been completed. CONCLUSION: Clinical data reviewed for etanercept-treated moderate to severe psoriasis have shown good efficacy, tolerability and a low adverse event profile.

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