Diagnosis of Basal Cell Carcinoma by Reflectance Confocal Microscopy: Study Design and Protocol of a Randomized Controlled Multicenter Trial.

BACKGROUND: Skin cancer, including basal cell carcinoma (BCC), has become a major health care problem. The limitations of a punch biopsy (at present the gold standard) as diagnostic method together with the increasing incidence of skin cancer point out the need for more accurate, cost-effective, and patient friendly diagnostic tools. In vivo reflectance confocal microscopy (RCM) is a noninvasive imaging technique that has great potential for skin cancer diagnosis. OBJECTIVE: To investigate whether in vivo RCM can correctly identify the subtype of BCC and to determine the cost-effectiveness of RCM compared with punch biopsy (usual care). STUDY DESIGN: Randomized controlled multicenter trial. METHODS: On the basis of 80% power and an alpha of 0.05, 329 patients with lesions clinically suspicious for BCC will be included in this study. Patients will be randomized for RCM or for a punch biopsy (usual care). When a BCC is diagnosed, surgical excision will follow and a follow-up visit will be planned 3 months later. Several questionnaires will be filled in (EQ-5D, EQ-5D VAS, iMTA PCQ, and TSQM-9). We will perform statistical analysis, cost-effectiveness, and patient outcome analysis after data collection. RESULTS: This research started in January 2016 and is ethically approved. We expect to finish this study at the end of 2018. CONCLUSIONS: In this study, we will investigate whether RCM is at least as good in identifying BCC subtypes as conventional pathological investigation of skin biopsies. Anticipating that RCM is found to be a cost-effective alternative, it saves on direct medical consumption like labor of the pathologist and other medical personnel as well as materials related to treatment failure with at least equal effectiveness. TRIAL REGISTRATION: Clinicaltrials.gov NCT02623101; https://clinicaltrials.gov/ct2/show/NCT02623101 (Archived by WebCite at http://www.webcitation.org/6id54WQa2).

Real-life Data on Patient Characteristics, Cost and Effectiveness of Field-directed Treatment for Actinic Keratoses: An Observational Study.

Actinic keratoses (AK) occur frequently; however, real-life clinical data on personalized treatment choice and costs are scarce. This multicentre one-year observational study investigated patient-characteristics, cost and effectiveness of methylaminolaevulinate photodynamic therapy (MAL-PDT), imiquimod (IMI) and 5-fluorour-acil (5-FU) in patients with AKs on the face/scalp. A total of 104 patients preferred MAL-PDT, 106 preferred IMI and 110 preferred 5-FU. At baseline, significant differences between treatment groups were found; most patients were severely affected (mean 32.5 AK in PDT-group, 20.2 in IMI-group, 22.8 in 5-FU-group). A mean reduction in lesions of 81% after MAL-PDT, 82% after IMI and 88% after 5-FU was found after one year. Annual costs were €1,950 for MAL-PDT, €877 for IMI and €738 for 5-FU. These results show that, compared with clinical trials, in the real-life clinical setting AK patients are usually more severely affected and treatment costs are much higher. Furthermore, patient characteristics are important factors in treatment choice.

A simple tool with which to study the course of chronic hand eczema in clinical practice: a reduced-item score.

BACKGROUND: Physicians need a simple, disease-specific tool with which to assess disease severity and the effect of therapeutic intervention in patients with chronic hand eczema. The currently available clinical scoring systems include numerous items, which makes them laborious to complete and limit their use in daily practice. OBJECTIVE: To develop a simple tool with which to assess disease severity of patients with chronic hand eczema. METHODS: We evaluated two tools, the Hand Eczema Severity Index (HECSI) and the Hand Eczema Area and Severity score, to determine their ability to predict the Investigator's Global Assessment (IGA) of disease severity in patients with moderate to severe hand eczema. We used a stepwise reduction analysis to determine a minimal set of significantly contributing items for predicting IGA. RESULTS: A three-item score, based on the highest observed value of induration, fissuring, and scaling, predicted IGA with a correlation of 0.667. The HECSI predicted the IGA with a correlation of 0.675. CONCLUSION: On the basis of this analysis, we propose a simple tool for clinical decision-making and evaluation of therapeutic intervention in daily practice.

Current and future treatment options for acne.

Acne is a frequent skin disease with abnormalities in the process of keratinization, sebaceous gland functioning and inflammation. In this review, our understanding of the pathogenesis of acne has been updated. An overview of efficacy and side effects of available anti-acne treatments is presented. Based on the present overview a recommendation for the treatment of various manifestations of acne is provided, also reconciling beneficial combinations of treatments. It is attractive to speculate that the increased insight into the pathogenesis of acne will create new treatment options. Challenging new options comprise blue light, photodynamic therapy, retinoic acid metabolism blocking agents and inhibitors of Th-1 cytokines.