Sodium hypochlorite body wash in the management of Staphylococcus aureus-colonized moderate-to-severe atopic dermatitis in infants, children, and adolescents.

OBJECTIVES: A cleansing body wash containing diluted sodium hypochlorite (0.006% NaOCl) was evaluated for management of moderate-to-severe Staphylococcus aureus-colonized, atopic dermatitis in children. METHODS: A 6-week, prospective, open-label study was conducted with 50 evaluable participants (ages 6 months to 17 years) who had moderate-to-severe atopic dermatitis with S aureus skin colonization documented by culture. Participants were instructed to continue using their current medications while using the study product, 0.006% NaOCl body wash, once daily to affected areas for 6 weeks. Primary outcome measures were Investigator's Global Assessment, Eczema Area and Severity Index, and Body Surface Area scores. Secondary outcome measures were the Visual Analog Scale for pruritus, Family Dermatology Life Quality Index, and Patient Satisfaction Questionnaire for Problem Areas. A subject daily diary and a six-item subject questionnaire that provided information on preferences for bleach bath vs body wash were secondary outcome measures. RESULTS: Daily use of the 0.006% NaOCl body wash led to improvement for all outcome measures comparing baseline to 2-week and to 6-week evaluations. Of the 50 skin S aureus-positive subjects, 32/50 (64%) were still positive at 2 weeks. A 36.5% decrease in subject's daily record of topical corticosteroid application at end of study compared to baseline was found. Participant surveys indicated preferences for the body wash over bleach baths. CONCLUSIONS: Sodium hypochlorite (NaOCl) body wash improved all outcome measures for moderate-to-severe S aureus-colonized AD in infants, children, and adolescents. The limited reduction in S aureus further suggests that sodium hypochlorite has ameliorative effects other than antimicrobial actions.

Quantitative evaluation of skin shrinkage associated with non-invasive skin tightening: a simple method for reproducible linear measurement using microtattoos.

Non-invasive skin-tightening devices can induce thermal denaturation and skin shrinkage via externally applied radiofrequency emissions or high-frequency ultrasound. Therefore, the purpose of this study is to develop and test a method for measurement of skin reduction associated with application of such energy devices. Twenty-five healthy participants with mild to moderate skin laxity of the arms were enrolled. Pinpoint microtattoos were placed at each of the treatment sites to delineate two 6 × 12 cm rectangles per subject. A non-stretchable filament, tape and marking pen apparatus was used to measure the size of each rectangle before treatment and at follow-up visit by two blinded investigators. After randomization, one side received a single pass with a radiofrequency device (6.78 MHz), while the contralateral side received multiple passes. Participants underwent two treatment sessions to each side 2 weeks apart, and returned for follow-up 4 weeks after the second treatment. Length and area measurement were analyzed to assess precision and accuracy of measurements and to compare efficacy of treatment between pre- and post-treatment. Concordance correlation coefficients (CCC) demonstrated substantial inter-investigator reliability and precision in length measurements (CCC, 0.94 to 0.98 in pre-treatment; 0.95 to 0.98 in post-treatment). Measurements at the 6-week post-treatment follow-up demonstrated a statistically significant skin reduction in all six of the measured parameters. A simple skin measurement method requiring minimal instrumentation can quantitatively evaluate skin shrinkage associated with non-invasive skin-tightening devices.

The diagnostic value and histologic correlate of distinct patterns of shiny white streaks for the diagnosis of melanoma: A retrospective, case-control study.

BACKGROUND: Shiny white streaks (SWSs) are best visualized with polarized dermoscopy and correlate with dermal fibroplasia histopathologically. SWSs have been described at higher frequencies in melanomas than in benign nevi. OBJECTIVE: We assessed the diagnostic value of different patterns of SWSs and their histologic correlate in melanocytic lesions. METHODS: Polarized dermoscopic images of 1507 histopathologically diagnosed melanocytic neoplasms were analyzed for presence and pattern of SWSs. Histology was also reviewed for correlation. RESULTS: Among 1507 melanocytic neoplasms, SWSs were observed in 31 of 144 melanomas (22%) and 22 of 1363 benign neoplasms (1.6%) (P < .001). The sensitivity and specificity of SWSs for melanoma were 22% and 98%, respectively. Diffuse SWSs exhibited the greatest diagnostic value for melanoma, with sensitivity of 11.8% and specificity of 99.5%. Focal central and peripheral SWSs were comparable in diagnostic significance. The presence of SWSs was highly uncommon in dysplastic nevi, whereas in certain benign subgroups of nevi such as Spitz nevi and atypical genital special site nevi, SWSs were not uncommon. Diffuse SWSs correlated with greater breadth of deep fibroplasia than focal SWSs (P = .009), and SWSs correlated with greater Breslow depth among melanomas (P = .007). LIMITATIONS: This study was retrospective. CONCLUSION: Polarized dermoscopy is a valuable diagnostic tool in the identification of SWSs, a feature that is highly specific for melanoma.

Subcutaneous infiltration of carbon dioxide (carboxytherapy) for abdominal fat reduction: A randomized clinical trial.

BACKGROUND: Noninvasive fat removal is preferred because of decreased downtime and lower perceived risk. It is important to seek new noninvasive fat removal treatments that are both safe and efficacious. OBJECTIVE: To assess the extent to which carboxytherapy, which is the insufflation of carbon dioxide gas into subcutaneous fat, results in reduction of fat volume. METHODS: In this randomized, sham-controlled, split-body study, adults (body mass index, 22-29 kg/m2) were randomized to receive 5 weekly infusions of 1000 cm3 of CO2 to 1 side of the abdomen, and 5 sham treatments to the contralateral side. The primary outcome measures were ultrasound measurement of fat layer thickness and total circumference before and after treatment. RESULTS: A total of 16 participants completed the study. Ultrasound measurement indicated less fat volume on the side treated with carboxytherapy 1 week after the last treatment (P = .011), but the lower fat volume was not maintained at 28 weeks. Total circumference decreased nominally but not significantly at week 5 compared with baseline (P = .0697). Participant body weights did not change over the entire course of the study (P = 1.00). LIMITATIONS: Limitations included modest sample size and some sources of error in the measurement of circumference and fat layer. CONCLUSION: Carboxytherapy provides a transient decrease in subcutaneous fat that may not persist. Treatment is well tolerated.

Developing drugs for treatment of atopic dermatitis in children (≥3 months to <18 years of age): Draft guidance for industry.

Atopic dermatitis is the most common chronic skin disease, and it primarily affects children. Although atopic dermatitis (AD) has the highest effect on burden of skin disease, no high-level studies have defined optimal therapy for severe disease. Corticosteroids have been used to treat AD since the 1950s and remain the only systemic medication with Food and Drug Administration approval for this indication in children, despite published guidelines of care that recommend against this option. Several clinical trials with level 1 evidence have supported the use of topical treatments for mild to moderate atopic dermatitis in adults and children, but these trials have had little consistency in protocol design. Consensus recommendations will help standardize clinical development and trial design for children. The Food and Drug Administration issues guidance documents for industry as a source for "the Agency's current thinking on a particular subject." Although they are nonbinding, industry considers these documents to be the standard for clinical development and trial design. Our consensus group is the first to specifically address clinical trial design in this population. We developed a draft guidance document for industry, Developing Drugs for Treatment of Atopic Dermatitis in Children (≥3 months to <18 years of age). This draft guidance has been submitted to the Food and Drug Administration based on a provision in the Federal Register (Good Guidance Practices).

A single-institution assessment of superficial spreading melanoma (SSM) in the pediatric population: Molecular and histopathologic features compared with adult SSM.

BACKGROUND: The epidemiology of pediatric melanoma is distinct from that seen in adults. This is more distinguishable when pediatric patients are separated into prepubertal and adolescent groups. OBJECTIVE: In this study, we compared epidemiologic, clinical, histologic, and molecular characteristics of pediatric superficial spreading melanoma (SSM) in prepubertal and adolescent patients to that in adults. METHOD: We reviewed our database for pediatric melanomas, comparing SSM data between pediatric and adult cases for pathologic stage at presentation, ratio of radial to vertical growth phase, average Breslow depth and mitotic index, and frequency of fluorescence in situ hybridization (FISH) positivity. RESULTS: Of 84 pediatric melanomas, 38 were SSM, and 5 of the latter (6%) were prepubertal. There were no significant differences when pediatric and adult SSM were compared for stage at presentation, ratio of radial to vertical growth phase, average Breslow depth and mitotic count, or frequency of FISH positivity. A significant difference was detected for SSM arising from a precursor nevus (80% of pediatric cases versus 30% of adult cases). LIMITATIONS: Follow-up time was limited for both cohorts. CONCLUSIONS: SSM melanoma is infrequent in childhood, particularly in the prepubertal years. Features such as tumor stage, Breslow depth, mitotic activity, and FISH positivity suggest morphologic and molecular characteristics similar to those of adult SSM.

Rate of serious infection in patients who are prescribed systemic biologic or nonbiologic agents for psoriasis: A large, single center, retrospective, observational cohort study.

BACKGROUND: Systemic biologic and nonbiologic agents used to treat psoriasis may or may not contribute to serious infection (SI) risk. Safety data, particularly for biologic agents, and associated risk for SI, are scarce. The study's aim was to explore the risk for SI in psoriasis patients exposed to systemic biologic or nonbiologic agents. METHODS: A large, single-center electronic medical record repository was searched between January 2010 and December 2014. Records for patients prescribed a systemic agent for psoriasis (SAP) with psoriasis or psoriatic arthritis diagnoses were included (ICD-9 codes 696.1 and 696.0, respectively). SIs were those who required hospitalization, and/or injectable antibacterial, antiviral or antifungal therapy. SIs occurring within 120 days after exposure to a SAP, were included for study. RESULTS: A total of 1,346 patients were exposed to a SAP between January 2010 and December 2014; 27 (2%) had a SI. Comparing biologic and nonbiologic agent exposure, no statistically significant difference for risk of SI was detectable (p = .83). CONCLUSION: In this population, the SI rate for biologic and nonbiologic systemic agents was clinically indistinguishable, thereby supporting consideration of the entire spectrum of available systemic therapeutic agents, both biologic and nonbiologic agents, for management of moderate to severe psoriasis.

Score of Toxic Epidermal Necrosis Predicts the Outcomes of Pediatric Epidermal Necrolysis.

BACKGROUND/OBJECTIVES: Epidermal necrolysis (Stevens-Johnson syndrome and toxic epidermal necrolysis) includes immune-mediated, life-threatening inflammatory blistering disorders that can affect children. The Score of Toxic Epidermal Necrosis (SCORTEN) tool has accurately predicted the outcome of these disorders in adults but has not been tested in children. METHODS: We performed a retrospective chart review to compare the accuracy of the adult SCORTEN tool with that of two modifications tailored to children in predicting disease outcome. RESULTS: The longer the patient's median length of hospital stay was, the higher the adult and two proposed pediatric SCORTENs were. In addition, all patients who died had SCORTENs greater than 4. CONCLUSION: The pediatric-modified tools were not superior to the adult SCORTEN, which accurately predicted outcome.

Utility of recorded guided imagery and relaxing music in reducing patient pain and anxiety, and surgeon anxiety, during cutaneous surgical procedures: A single-blinded randomized controlled trial.

BACKGROUND: Guided imagery and music can reportedly reduce pain and anxiety during surgery, but no comparative study has been performed for cutaneous surgery to our knowledge. OBJECTIVES: We sought to determine whether short-contact recorded guided imagery or relaxing music could reduce patient pain and anxiety, and surgeon anxiety, during cutaneous surgical procedures. METHODS: Subjects were adults undergoing excisional surgery for basal and squamous cell carcinoma. Randomization was to guided imagery (n = 50), relaxing music (n = 54), or control group (n = 51). Primary outcomes were pain and anxiety measured using visual analog scale and 6-item short-form of the State-Trait Anxiety Inventory, respectively. Secondary outcomes were anxiety of surgeons measured by the 6-item short-form of the State-Trait Anxiety Inventory and physical stress of patients conveyed by vital signs, respectively. RESULTS: There were no significant differences in subjects' pain, anxiety, blood pressure, and pulse rate across groups. In the recorded guided imagery and the relaxing music group, surgeon anxiety was significantly lower than in the control group. LIMITATIONS: Patients could not be blinded. CONCLUSION: Short-contact recorded guided imagery and relaxing music appear not to reduce patient pain and anxiety during excisional procedures under local anesthetic. However, surgeon anxiety may be reduced when patients are listening to such recordings.

Psoriasis and Cardiometabolic Disease: A Brief, Focused, Educational Intervention on Cardiometabolic Risks.

BACKGROUND: To assess baseline knowledge and awareness of cardiometabolic comorbidities in subjects with psoriasis. To determine the impact of a verbal scripted educational intervention. METHODS: Fifty-six adults with a clinical diagnosis of moderate to severe psoriasis completed a 12-item questionnaire about psoriasis comorbidity awareness and knowledge at 2 time points: pre-intervention (PR-I) and post-intervention (PO-I). The PR-I questionnaire collected information on history of psoriasis and cardiometabolic disease. A 5-minute scripted educational intervention was administered during a single study visit to subjects immediately after PR-I but prior to PO-I questionnaires. Subjects also completed a final questionnaire at 2 months follow-up (2-MF). Responses were statistically analyzed using McNemar's test. RESULTS: Fifty-six subjects (26 females, 30 males, mean age 51 years, range 21 to 83 years) participated in the PR-I and PO-I and 46 (82%) participated in 2-MF. Significant improvements were noted for 10 of 11 questions between PR-I and PO-I, and 8 of the scores remained significantly improved (compared with baseline) at 2-MF (P<0.05). At 2-MF, 65% of subjects had seen a primary care physician within the 2-month interval from PO-I to 2-MF, and another 26% planned to visit a primary care physician in the near future. Furthermore, 85% had checked their blood pressure in the past 2 months. CONCLUSIONS: Measures of knowledge and awareness of psoriasis and cardiometabolic comorbidities were significantly improved at PO-I and retained for most measures at 2-MF. An educational intervention, as utilized in this study, warrants consideration to enhance cardiometabolic-based knowledge and awareness in patients with psoriasis.

J Drugs Dermatol. 2016;15(10):1176-1180.

Evaluation of benefit to educational material for photoprotection in those with cutaneous lupus erythematosus.

BACKGROUND: Photosensitivity (PS) in cutaneous lupus erythematosus (CLE) contributes to decreased quality of life (QoL). AIMS: We aimed to assess baseline knowledge about sun protection in persons with CLE and identify knowledge differences by race. Additionally, we aimed to determine the impact of a verbal educational intervention on photoprotection and CLE. METHODS: 31 adults with CLE were recruited from an academic-based dermatology clinic and completed a 17-item questionnaire about CLE and sun protection at three time points: pre- intervention (PR-I), post-intervention (PO-I), and 3-month phone follow up (3MF). An educational intervention using American Academy of Dermatology CLE and sun protection education materials was delivered between PR-I and PO-I. RESULTS: 31 subjects participated at PR-I and PO-I, and 25 subjects (81%) at 3MF. Baseline CLE-related PS and photoprotection knowledge differed significantly by race, with non-Caucasians demonstrating less knowledge (P= 0.049). Knowledge about sun exposure being linked to lupus increased from 81% to 97% (P=0.25) between PR-I and PO-I. At PR-I, 19% agreed that smoking was linked to lupus compared to 90% PO-I (P<0.001). There was increased knowledge of lupus risk for non-Caucasians, UV exposure indoors, and photo-avoidance during peak daytime (P<0.001). CONCLUSION: There is a baseline disparity in knowledge related to PS and photo protection in CLE by race. A short educational intervention successfully improved immediate lupus-related PS and sun exposure knowledge, but knowledge was not retained long-term. It appears educational materials must be improved.

Life-threatening dermatologic adverse events in oncology.

The incidences of life-threatening toxicities such as Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are inconsistently reported. The potential association of anticancer agents with SJS or TEN has not been systematically investigated. We searched the literature (Ovid: 1950 to June 2013 and PubMed: 1948 to June 2013) using terms for SJS/TEN and anticancer therapies. Primary case reports, case series, and clinical trials were included. In addition, MedWatch, the Food and Drug Administration Adverse Event Reporting System (FAERS), was searched (1968 to August 2012) for SJS/TEN reports associated with anticancer therapies. Proportional reporting ratios (PRR>2, N>3), empirical Bayes geometric mean (EBGM>2, N>3), and lower 95% confidence interval (EBGM0.05>2) were used as thresholds to constitute a signal of association between SJS/TEN and anticancer drugs. There were 46 SJS and 37 TEN cases associated with 18 and 22 anticancer drugs in the literature, respectively. Among cases in the FAERS, significant signals were associated with SJS for bendamustine and with TEN for bendamustine, busulfan, chlorambucil, fludarabine, lomustine, and procarbazine. Several drugs reported in the published literature to be associated with SJS/TEN were not found to have significant signals in FAERS. Proactive pharmacovigilance to detect and define safety signals serves to aid oncology practitioners in the recognition of possible, yet uncommon, serious, and/or life-threatening skin reactions.

Pain in naïve and non-naïve subjects undergoing nonablative skin tightening dermatologic procedures: a nested randomized control trial.

BACKGROUND: Pain is expected during noninvasive skin tightening and can be anxiety provoking, especially for those who have not had prior treatments. OBJECTIVE: To compare pain reported by patients naïve to nonablative skin tightening energy devices with those who were not naive. METHODS AND MATERIALS: The non-naïve group at least three nonablative laser procedures or one nonablative skin tightening procedure, and the naïve group no previous treatments. Four sites at each of two anatomic locations (periorbital and midface or cheek) were treated in each subject with needle prick, pulsed dye laser, radiofrequency, and ultrasound with the order of the interventions randomized. All interventions except ultrasound were also applied to three abdominal sites. The difference in mean pain scores between naïve and nonnaïve subjects were averaged over the anatomic sites. RESULTS: Ten naïve and 10 non-naïve subjects completed study procedures. Mean pain scores ranged from 1.3 to 4.9. The mean for all naïve conditions was 2.3 ± 1.0, vs 2.2 ± 1.4 for non-naïve conditions. There was no overall difference according to group, device, or anatomic area. CONCLUSIONS: There was no significant difference in pain between naïve and non-naïve subjects undergoing cutaneous energy treatments. Individual devices may elicit more pain at specific anatomic locations.