Photodynamic therapy with a 5-ALA patch does not increase the risk of conversion of actinic keratoses into squamous cell carcinoma: Results of a multicentre non-interventional study.

BACKGROUND: It is important to collect data about the risk of transformation of an actinic keratosis (AK) lesion into squamous cell carcinoma (SCC) after a single photodynamic therapy (PDT) with 5-ALA patch for a longer follow-up period under daily routine. QUESTIONS ADDRESSED: The purpose of this non-interventional study (NIS) was to collect data on the frequency of occurrence of SCCs in the treated area during an interval of 2 years after a single 5-ALA patch-PDT. EXPERIMENTAL DESIGN: This prospective observational case-only study included patients with mild AK lesions on the head and face treated with 5-ALA patch-PDT according to the Summary of Product Characteristics (SPC). RESULTS: In 370 patients, the risk of transformation of their treated AK lesion into SCC was 0.073% with its exact 95% confidence interval using the Poisson distribution of [0.009%, 0.262%]. The rate of complete clinical clearance on lesion basis after 3 months was 84.3%. CONCLUSION: The efficacy and the safety results show no observation of an increased risk for conversion of an AK into a SCC 2 years after a single 5-ALA patch-PDT. Additionally, the high clinical complete remission rate under routine conditions is comparable to the rates observed in the approval trials.

Chronic spontaneous urticaria - a management pathway for patients with chronic spontaneous urticaria.

Chronic spontaneous urticaria (CSU) is a common and challenging disease, especially with respect to healthcare provision in the context of the German statutory health insurance system. If treatment with second-generation antihistamines is unsuccessful, current guidelines recommend further therapeutic options. However, most of these are off-label. This discrepancy between treatment according to guidelines and the ability to prescribe drugs at the expense of the statutory health insurance (reimbursability) often leads to uncertainties in everyday clinical practice. In addition, physicians prescribing certain drugs are faced with the difficulty of measuring and documenting therapeutic success/outcome. Respective outcome measurement methods have not yet been established in daily practice. Using a consensus process, a working group composed of dermatologists in private practice and specialized urticaria centers has defined a practical pathway for the implementation of current treatment recommendations based on the 2013 S3 guidelines for urticaria. Here, we present a diagnostic and therapeutic management pathway for CSU. Further, we discuss prescription issues in daily practice, including updosing of antihistamines, with regard to cost-effectiveness and drug approval on the basis of published studies and current legislation. Constituting the highest treatment level, the use of cyclosporine A, montelukast, and omalizumab, which has recently become available as therapeutic option, is reviewed. The urticaria control test (UCT) is presented as a valid outcome measure in routine practice. Our objective was to provide physicians in private practice with a practical guideline-based therapeutic decision tool, taking into account the requirements imposed by the statutory health insurance system. It is not meant to replace individualized history taking or treatment of this heterogeneous disease. Rather, we would like to suggest reference points for clinical diagnosis and treatment of CSU.

Vitamin D supply: from sun or pill? - Attitudes and recommendation on vitamin D and impact on sun protection practices among German general practitioners evaluated by the network of dermato-oncologists, Onkoderm e.V.

Recommendations concerning the intake of vitamin D and/or sunlight exposure in the handling of patients with vitamin D deficiency remain a matter of debate. The present study of the German network of dermato-oncologists (Onkoderm e.V.) refers to an inquiry conducted among general practitioners on this and related issues. Based on 448 answers provided to 10 distinct questions, the consulted physicians recommended vitamin D intake (94% replies) and/or exposure to sunlight (63% replies) in their patients with vitamin D deficiency. An average of approximately 26 min daily unprotected exposure to sunlight at midday in spring and summer was recommended. Nevertheless, 91% of the physicians considered the use of creams protecting against sunlight to be judicious. However, only 54% of physicians considered it worthwhile practice to protect oneself intensively against UV radiation. This study indicates evidence of a reduction in sun protection practices. Yet, approximately 25% of the patients were considered to present vitamin D deficiency and, hence, recommendations to prevent or correct the latter situation should not be ignored. Nevertheless, we consider that there is a need to focus messages regarding sun exposure and for continued sun protection practices. These messages should specifically focus on the vitamin D issue to ensure that the incidence of skin cancer does not increase.