Faculty Bibliography

Various extracts of polypodium leucotomos (PLE) applied topically or taken orally have been shown to have several beneficial antioxidant, photoprotectant, antimutagenic, and immunoregulatory effects. Modern studies have evaluated the efficacy of PLE orally as a photoprotective agent and for use in several photo-aggravated dermatologic disorders such as polymorphous light eruption, other photodermatoses, and melasma. No articles have been published evaluating the safety of PLE. We performed a PUBMED search for any randomized clinical trials related to PLE, or anapsos, a synonym. The primary safety endpoint of the review was any mention of an adverse event, side effect, or toxicity. Overall, 19 human and 6 basic science studies were included spanning over 40 years of research. Oral PLE was administered at daily doses ranging from 120 mg to 1080 mg. No adverse effects were reported in laboratory studies. In humans, side effects (gastrointestinal complaints and pruritus) were mild to moderate and found only in very small numbers of patients overall (16/1016 [2%]). This review concludes PLE is well tolerated at all doses administered and associated with a negligible risk of side effects

J Drugs Dermatol. 2015;14(3):254-259.

OBJECTIVE: To determine if the high negative predictive value of a multispectral digital skin lesion analysis that has been previously found in an academic-based trial would be similar in a community-based setting with its expected different distribution of pigmented lesions. DESIGN: Data were collected from patients undergoing routine skin examinations over a one-year period at a community-based practice in Florida. All lesions that were selected for biopsy to rule out melanoma were also imaged with multispectral digital skin lesion analysis prior to biopsy. Histopathological diagnoses and multispectral digital skin lesion analysis results were reviewed and compared with findings from a prior primarily academic center-based multispectral digital skin lesion analysis trial. SETTING/PARTICIPANTS: Community-based clinical setting in Florida. MEASUREMENTS: Negative predictive value, sensitivity, and specificity. RESULTS: One hundred thirty-seven consecutive lesions were selected for biopsy and also analyzed via multispectral digital skin lesion analysis. All 21 cases with multispectral digital skin lesion analysis "Low Disorganization" readings were all histologically benign (100% negative predictive value, 95% lower confidence boundary = 96.9%). The negative predictive value and the sensitivity were not significantly different than what was found in the prior academic-based multispectral digital skin lesion analysis trial. Multispectral digital skin lesion analysis also correctly identified all high-risk lesions, which were subsequently confirmed via histology to be one invasive melanoma and 15 moderately dysplastic nevi (100% sensitivity). Specificity with multispectral digital skin lesion analysis was significantly higher than reported in the academic-based multispectral digital skin lesion analysis trial (18% vs. 10%, p=0.02). CONCLUSION: Because of the high negative predictive value achieved by multispectral digital skin lesion analysis, lesions with readings of "Low Disorganization" may be considered for observation versus biopsy. Similar to what was noted in the academic center setting, multispectral digital skin lesion analysis may help dermatologists reduce the number of unnecessary biopsies while improving diagnostic accuracy.

OBJECTIVE: To observe how a multispectral digital skin lesion analysis device was used by dermatologists in a community-based clinical setting and determine differences from a university-based environment. DESIGN: Use of multispectral digital skin lesion analysis was incorporated into a community-based practice by 12 dermatologists across six clinics over seven consecutive days with the data provided by the device integrated as an adjuvant to their clinical evaluation for their pigmented lesion management decisions. Multispectral digital skin lesion analysis results were collected electronically for lesions prior to biopsy, and histopathological evaluation was performed for the biopsied lesions. Multispectral digital skin lesion analysis and pathology results were then compared to assess the degree of morphological disorganization. SETTING/PARTICIPANTS: Study of 160 consecutive patients in community-based clinical setting. MEASUREMENTS: Proportion of "low" and "high" disorganization lesions identified by multispectral digital skin lesion analysis. RESULTS: Of the 344 pigmented skin lesions analyzed by multispectral digital skin lesion analysis, 255 were high disorganization, 113 of which were biopsied. Of the 89 lesions evaluated by multispectral digital skin lesion analysis to be low disorganization, seven were biopsied and all pathology was benign. Data demonstrate a higher rate of multispectral digital skin lesion analysis low disorganization readings for pigmented skin lesions (32% for single use per patient lesions, p<0.0001; 26% for all lesions, p<0.0001) than observed in the pigmented lesions clinics providing data for the university-based clinical study (10%). CONCLUSION: Multispectral digital skin lesion analysis in the community-based clinical setting may outperform specificity results from the university-based clinical trial study, perhaps because of a higher proportion of subtle lesions encountered at high-risk pigmented lesion clinics of participating major academic centers as compared with those in a community-based practice setting.

OBJECTIVE: Risk prediction models for primary malignant melanoma thus far have relied on qualitative patient information. The authors propose a quantitative diagnostic predictive probability model using Multispectral Digital Skin Lesion Analysis for melanoma and other high-risk pigmented lesions and evaluate its effectiveness optimizing biopsy decisions by dermatologists. DESIGN: Data from 1,632 pigmented lesions analyzed by a Multispectral Digital Skin Lesion Analysis device were used to perform a logistic regression analysis. This new quantitative melanoma or melanoma/atypical melanocytic hyperplasia/high-grade dysplastic nevus probability model was then evaluated to determine its impact on dermatologist decisions to biopsy pigmented lesions clinically suggestive of melanoma. Participants were given an electronic keypad and answered "yes" or "no" if they would biopsy each of 12 pigmented lesions when presented first with patient history, clinical images, and dermoscopic images and again when subsequently shown Multispectral Digital Skin Lesion Analysis data. SETTING/PARTICIPANTS: Study of 191 dermatologists at a medical conference. MEASUREMENTS: Sensitivity, specificity, biopsy accuracy, overall biopsy rate, and percentage dermatologists biopsying all five melanomas. RESULTS: Dermatologists were significantly more sensitive, specific, and accurate while decreasing overall biopsy rates with Multispectral Digital Skin Lesion Analysis probability information. CONCLUSION: Integration of Multispectral Digital Skin Lesion Analysis probability information in the biopsy evaluation and selection process of pigmented lesions has the potential to improve melanoma sensitivity of dermatologists without the concomitant costs associated with additional biopsies being performed.

BACKGROUND: The rates of short-term clearance of actinic keratoses appear to be comparable in clinical trials of topical treatments used in field therapy, but direct comparisons of efficacy results can be problematic. Trials use different efficacy end points, have different study designs, involve different anatomic sites, and enroll different patient populations. In addition, because adherence in real-world clinical practice differs from that observed in clinical trials, conclusions drawn from efficacy outcomes can be misleading. The objective of this review was to examine the efficacy end points used in studies of topical therapy for actinic keratosis, address other factors influencing efficacy outcomes in these studies, and discuss the possible influence of nonadherence on effectiveness. METHODS: Review of the available literature on topical therapy for actinic keratosis. RESULTS: The end points used to determine efficacy of therapies for actinic keratosis include a disparate group of outcomes, which can often make comparison between studies impossible. CONCLUSIONS: Efficacy end points of clinical studies designed to assess the treatment of actinic keratosis should be standardized to facilitate between-trial comparisons, and studies should focus on the end points that are most clinically relevant.