Faculty Bibliography

Background: More than 90% of ~2.5 million surgical biopsies performed to rule out melanoma in the U.S. alone are benign and classified as neither invasive melanomas nor melanomas in situ by histopathology. A recently described adhesive patch skin biopsy based noninvasive gene expression test (pigmented lesion assay; PLA) demonstrated utility and differentiated benign from malignant pigmented skin lesions with a test performance that exceeded visual inspection (VI) and a sensitivity that matching the criterion standard of dermatopathology. However, cost and outcome implications of using this molecular test versus VI have not been evaluated.
Objective(s): To determine potential cost savings and impact on outcome of PLA use versus VI in patients with pigmented cutaneous lesions suggestive of melanoma. Design and setting: Health economic analyses were performed from average U.S. insurance reimbursement values, comparing the real-world impact of the PLA with VI. Data sources were from published clinical validation and utility studies as well as from routine use of the test in U.S. dermatology practices, augmented by fee schedules of CMS.
Result(s): The biopsy ratio declined from 12.5 for VI to 2.4 for PLA use; correspondingly, the number needed to excise (NNE) declined from 2.85 for VI to 1.37 for PLA use. The 1.77-fold increase in specificity of PLA over VI also resulted in lower costs for initial biopsy ($211), subsequent excisions ($86), surveillance management ($77), and management of melanoma ($508). There was $31 average savings from avoidance of lost work productivity, and improvement in patient experience as assessed by quality adjusted life years (gain of 0.016 years). Conclusions and relevance: The higher accuracy of PLA use versus VI resulted in fewer unnecessary procedures and office visits, while not compromising early melanoma detection. The consequence effects are potentially reduced direct medical costs, reduced work productivity loss, and improved patient experience and care.
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Background: The topical adhesive 2-octyl cyanoacrylate has been used as an alternative to sutures for closure of skin in a variety of surgical procedures. While there have been benefits in terms of ease of application and cosmetic result, a high incidence of allergic contact dermatitis and exothermic reactions has been a barrier to use. Objectives. To investigate the feasibility of using a novel formulation of 2-octyl cyanoacrylate (Actabond-Bergen Medical Products, Morris Plains, New Jersey) for skin closure after surgical excision of cutaneous lesions.
Method(s): We examined the results of office-based surgical excision procedures using a novel formulation of 2-octyl cyanoacrylate for skin closure. Photographs were taken preoperatively, intraoperatively (open wound, before adhesive application, following adhesive application), and 2 weeks after surgery. At follow-up, all incisions were examined for cosmetic result, skin edge separation, erythema, and abscess formation. Patient satisfaction was also assessed.
Result(s): Ten lesions in 9 consecutive patients undergoing cutaneous excision by two surgeons were included in the study. The average age of included patients was 42. Lesions were excised from the trunk (6) and extremities (4). Lesion types included 3 dysplastic nevi, 3 sebaceous cysts, 3 lipomas, and 1 squamous cell carcinoma. At 2-week follow-up, all wounds were healed without any signs of dehiscence or infection. All wounds demonstrated esthetic closure without suture tracts. None of the patients developed allergic contact dermatitis or burns. On a 1-10 scale, respondents' average satisfaction with the method was 7.7. For patients who had previous skin suture closures, 83% preferred adhesive. Conclusion and relevance. A novel formulation of 2-octyl cyanoacrylate topical adhesive demonstrated feasibility as a potential alternative to the use of sutures for skin closure. In this small case series, all patients had an excellent esthetic result with no complications. Compared with previous iterations of 2-octyl cyanoacrylate, there were no allergic or exothermic reactions in this pilot series. Larger studies need to be performed to further determine advantages that may exist using this closure method compared with standard techniques.
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The Pigmented Lesion Assay (PLA) is a gene expression test that helps rule out melanoma and has the potential to reduce the need for surgical biopsies of atypical pigmented skin lesions. Utilizing a new technological platform for the non-invasive profiling of skin, the assay analyzes samples collected from adhesive patches for expression of two key genes (PRAME and LINC00518) known to be overexpressed in melanoma. The test result is binary (positive/negative) based on the detection of one or both genes. PLA positive cases are generally biopsied to establish the histopathologic diagosis, while PLA negative cases are considered for ongoing monitoring. The combination of visual inspection with histopathology, the current gold standard for melanoma diagnosis, has a relatively low negative predictive value (NPV) of approximately 83%, meaning that 17% of melanomas will be interpreted as benign lesions. In contrast, the PLA has a very high NPV (>99%). Further, with its high specificity (69-91%), use of the PLA can reduce the number of false positive samples subjected to histopathology review. By adding the PLA to the current care pathway, the number of surgical biopsies needed to find a melanoma (number needed to biopsy) is markedly reduced from 20-25 biopsies for dermatologists and 39 biopsies for physician assistants, to an average of 2.7. To date, unnecessary surgical procedures of benign lesions have been reduced by 88% based on a sample of more than 20,000 analyzed cases. This has resulted in fewer missed melanomas and significant cost savings to health care systems.

IMPORTANCE/OBJECTIVE:A 31-gene expression profile (31-GEP) test to predict metastatic risk in patients with cutaneous malignant melanoma has previously been validated and is available for clinical use. The impact of the availability of such a test on clinical decision-making has previously been studied. However, little is known about which factors play a role in clinicians' decision to utilize the test. OBJECTIVE:To determine factors affecting clinicians' decisions to utilize the 31-GEP test for metastatic risk stratification in patients with cutaneous malignant melanoma. DESIGN, SETTING, AND PARTICIPANTS/METHODS:Dermatologists attending a national conference completed a series of questions based around four clinical vignettes using an audience response system. The vignettes and associated questions were designed to determine the impact of three factors-Breslow thickness, ulceration, and sentinel lymph node biopsy status-on the decision to order the 31-GEP test. Main Outcomes and Measures: The percentage of respondents who would order the 31-GEP test in the various clinical scenarios was quantified. Differences between groups were assessed using the chi-squared test. RESULTS:A total of 181/187 individuals completed the survey (96.8% response rate). For tumors with a Breslow thickness ≥0.5 mm, a majority of respondents reported that they would recommend the 31-GEP test. Ulceration was associated with a statistically significant increase in the percentage of clinicians who would recommend the assay for all but the thickest (2.1 mm) tumors. A negative SLN was only associated with a statistically significant increase in the percentage of clinicians who would recommend the test for the thinnest (0.26 mm) tumors (22% to 34%, P=0.033). CONCLUSIONS AND RELEVANCE/CONCLUSIONS:Ulceration appears to be the most important factor impacting clinicians when deciding to order the 31-GEP test to assess risk for melanoma metastasis. J Drugs Dermatol. 2018;17(5):544-547. <p>THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.</p>.

Though screening for skin cancer is an essential practice in dermatology, limited data are published on dermatologists' total body skin examination (TBSE) behaviors. We surveyed 6500 dermatologists on their TBSE practices, including questions about less commonly examined body sites. We found varied TBSE practices among all dermatologists and discrepancies in examinations between dermatologists of opposite genders. J Drugs Dermatol. 2018;17(5):516-520.

BACKGROUND:The value of additional photoprotection provided by use of high SPF sunscreens is controversial and limited clinical evidence exists. OBJECTIVE:To compare the sunburn protection provided by SPF100+ and SPF50+ sunscreen in conditions of actual use. METHODS:199 healthy men and women (≥18 years) participated in a natural sunlight, single exposure, split face, randomized, double blind study in Vail, Colorado. Each participant wore both sunscreens simultaneously during activities with no usage restrictions other than treatment area designation. Erythema was clinically assessed the day following exposure. Comparative efficacy was evaluated through bilateral comparison of sunburn between treatment areas and erythema score as evaluated separately for each treatment area. RESULTS:Following an average 6.1 ± 1.3 hours of sun exposure, investigator blinded evaluation identified 55.3% (110/199) of the participants as more sunburned on the SPF50+ and 5% (10/199) on the SPF100+ protected side. Post exposure, 40.7% (81/199) of the participants exhibited increased erythema scores ≥ 1 on the SPF50+ protected side as compared to 13.6% (27/199) on the SPF100+. LIMITATIONS/CONCLUSIONS:Single day exposure may not extrapolate to benefits of longer-term protection. CONCLUSION/CONCLUSIONS:SPF100+ sunscreen was significantly more effective in protecting against sunburn than SPF50+ sunscreen in actual-use conditions. TRIAL REGISTRATION/BACKGROUND:ClinicalTrials.gov(NCT02952235).

Multispectral digital skin lesion analysis (MSDSLA) is both sensitive and specific in the detection of malignant melanoma by dermatologists and nondermatologists, and data have shown that MSDSLA can be a valuable tool in the evaluation of pigmented skin lesions (PSLs). This study aimed to aggregate data from 7 prior studies to provide a comprehensive overview and evaluate the consistency of the effects of MSDSLA when used in conjunction with clinical examination and dermoscopy to evaluate PSLs.

BACKGROUND:Studies show that sunscreen under real-life conditions is often not reapplied and/or applied insufficiently. This study investigated the durability of 2 current sunscreens with different SPF protection over an 8-hour period under simulated real-life conditions. METHODS:Participants (n=24) were randomized into two study groups utilizing either 2 mg/cm2 (FDA testing concentration) or 1 mg/cm2 (real-life application levels) of sunscreen. Two current SPF 15 and 70 sunscreens were applied to test spots on each participant's back. SPF values were obtained at baseline, 3.5, and 8 hours after initial application, during which subjects completed 30 minutes of moderate exercise followed by 80 minutes of water exposure. RESULTS:Participants in both dose study groups revealed only a 15-40% overall decrease in their SPF protection 8 hours after application. The study group that received half the FDA test concentration of sunscreen achieved approximately half or less the labeled SPF. At 8 hours, the test sites that received SPF 70 maintained an average SPF greater than 64 (2 mg/cm2 application) and 26 (1 mg/cm2 application). Similarly, the SPF 15 product test sites revealed an in vivo protection of 13 (2 mg/cm2) and 7 (1 mg/cm2). CONCLUSION/CONCLUSIONS:This study demonstrates that current sunscreens may be durable on skin even following significant exercise and water exposure, suggesting that reapplication intervals may be longer than currently recommended. In addition, the higher SPF sunscreen maintained a skin cancer-protective level of SPF following extended use. <p><em>J Drugs Dermatol. 2018;17(1):116-117.</em></p>.