A case of multiple familial trichoepitheliomas responding to treatment with the Hedgehog signaling pathway inhibitor vismodegib.

Multiple familial trichoepitheliomas (MFT) is an autosomal dominantly inherited disease characterized by multiple skin appendage tumors. We describe a patient showing a continuous spectrum of follicular differentiated neoplasms including classical trichoepitheliomas but also infiltrative growing and finally metastasizing malignant follicular differentiated tumors. Germline mutation analysis revealed a nonsense mutation in the cylindromatosis (CYLD) gene.

Effect of Crossover in Oncology Clinical Trials on Evidence Levels in Early Benefit Assessment in Germany.

Background: In oncology clinical trials, crossover is used frequently but may lead to uncertainties regarding treatment effects.

Objective: To investigate the handling of evidence from crossover trials by the European Medicines Agency (EMA) and the German Federal Joint Committee (G-BA).

Methods: For oncology medicines with early benefit assessments before January 2015, presence of crossover, clinical data, EMA requests for additional data, and G-BA benefit ratings/evidence levels were analyzed from manufacturers' dossiers, G-BA appraisals, European Public Assessment Reports, and original publications.

Inconsistent approaches of the G-BA regarding acceptance of primary study endpoints as being relevant to patients - an analysis of three disease areas: oncological, metabolic, and infectious diseases.

Background: Previous evaluations of oncological medicines in the German early benefit assessment (EBA) procedure have demonstrated inconsistent acceptance of endpoints by regulatory authorities and the Federal Joint Committee (G-BA). Accepted standard endpoints for regulatory purposes are frequently not considered as patient-relevant in the German EBA system. In this study the acceptance of clinically acknowledged primary endpoints (PEPs) from regulatory trials in EBAs conducted by the G-BA was evaluated across three therapeutic areas.

Targets for Neoadjuvant Therapy - The Preferences of Patients with Early Breast Cancer.

Therapists and administrative bodies consider a pathological complete remission as an independent and relevant endpoint in evaluations of the clinical utility of neoadjuvant therapy for early breast cancer. The present study aims to investigate which treatment outcomes of a neoadjuvant therapy are considered by the patients themselves to be relevant. With the help of analytic hierarchy process (AHP) methods patient preferences about the treatment targets of neoadjuvant therapy were assessed quantitatively.

Aetiology, comorbidities and cofactors of chronic leg ulcers: retrospective evaluation of 1 000 patients from 10 specialised dermatological wound care centers in Germany.

Numerous comorbidities and cofactors have been known to influence wound healing processes. In this multicentre study, clinical data of 1 000 patients with chronic leg ulcers from ten specialised dermatological wound care centers were analysed. The patient cohort comprised 567 females and 433 males with an average age of 69·9 years.

Cold atmospheric plasma for local infection control and subsequent pain reduction in a patient with chronic post-operative ear infection.

Following surgery of cholesteatoma, a patient developed a chronic infection of the external auditory canal, including extended-spectrum β-lactamase producing Escherichia coli, which caused severe pain. The application of cold atmospheric plasma resulted in a significant reduction in pain and clearance of bacterial carriage, allowing antibiotics and analgesics to be ceased.

[Current detection rates of multiresistant gram negative bacteria (3MRGN, 4MRGN) in patients with chronic leg ulcers].

Background: Due to the increasing problem of antibiotic resistance in gram-negative pathogens, the Commission for Hospital Hygiene and Infection Prevention (KRINKO) decided to establish a new clinically oriented definition of multi-resistance. Gram-negative pathogens with a multidrug-resistance (MRGN) are divided into those with resistance to three (3MRGN) or four (4MRGN) antibiotic groups.

Patients And Methods: In this multicenter study which was done in ten dermatological wound clinics, the bacteriological swabs from up to 100 patients with chronic leg ulcers per center were analyzed according to the current classification KRINKO and evaluated.

W.A.R. scores in patients with chronic leg ulcers: results of a multicentre study.

Objective: To assess the individual patient's risk of wound infection using the wounds-at-risk (W.A.R.

Bacteriological pathogen spectrum of chronic leg ulcers: Results of a multicenter trial in dermatologic wound care centers differentiated by regions.

Background: In almost every chronic wound different bacteria species can be detected.

Patients And Methods: Retrospective, multicenter evaluation of bacterial swab results from 2010 and 2011 in patients with chronic leg ulcer treated in 10 dermatologic wound care centers from 5 regions in Germany.

Results: Data of 970 patients were analyzed.

Randomized placebo-controlled human pilot study of cold atmospheric argon plasma on skin graft donor sites.

Cold atmospheric plasma has already been shown to decrease the bacterial load in chronic wounds. However, until now it is not yet known if plasma treatment can also improve wound healing. We aimed to assess the impact of cold atmospheric argon plasma on the process of donor site healing.

Five patients with melanosis of the nipple and areola clinically mimicking melanoma.

Background: Pigmented lesions on the nipple and areola concern patients and physicians as melanoma and pigmented mammary Paget's disease must be considered in the differential diagnoses. There have been only six case reports of melanosis of the nipple and areola in the medical literature yet five cases presented to our department in a 26-month period.

Method: Five women aged between 26 and 34 years presented with pigmentation of the areola and/or nipple.

Cold atmospheric plasma devices for medical issues.

Cold atmospheric plasma science is an innovative upcoming technology for the medical sector. The plasma composition and subsequent effects on cells, tissues and pathogens can vary enormously depending on the plasma source, the plasma settings and the ambient conditions. Cold atmospheric plasmas consist of a highly reactive mix of ions and electrons, reactive molecules, excited species, electric fields and to some extent also UV radiation.

Cold atmospheric air plasma sterilization against spores and other microorganisms of clinical interest.

Physical cold atmospheric surface microdischarge (SMD) plasma operating in ambient air has promising properties for the sterilization of sensitive medical devices where conventional methods are not applicable. Furthermore, SMD plasma could revolutionize the field of disinfection at health care facilities. The antimicrobial effects on Gram-negative and Gram-positive bacteria of clinical relevance, as well as the fungus Candida albicans, were tested.

Contact-free inactivation of Candida albicans biofilms by cold atmospheric air plasma.

Candida albicans is one of the main species able to form a biofilm on almost any surface, causing both skin and superficial mucosal infections. The worldwide increase in antifungal resistance has led to a decrease in the efficacy of standard therapies, prolonging treatment time and increasing health care costs. Therefore, the aim of this work was to demonstrate the applicability of atmospheric plasma at room temperature for inactivating C.

Successful and safe use of 2 min cold atmospheric argon plasma in chronic wounds: results of a randomized controlled trial.

Background: The development of antibiotic resistance by microorganisms is an increasing problem in medicine. In chronic wounds, bacterial colonization is associated with impaired healing. Cold atmospheric plasma is an innovative promising tool to deal with these problems.

A randomized two-sided placebo-controlled study on the efficacy and safety of atmospheric non-thermal argon plasma for pruritus.

Background: To look into new potential indications for physical plasma and because some reports suggest plasma having antipruritic effects, we investigated the treatment of pruritus that often represents a therapeutic challenge.

Objectives: To assess the efficacy and safety of cold atmospheric argon plasma as add-on-therapy in pruritic diseases.

Methods: We treated 46 patients with various pruritic diseases with cold plasma for 2 min daily in addition to standard treatment.

Plasma medicine: possible applications in dermatology.

As a result of both the better understanding of complex plasma phenomena and the development of new plasma sources in the past few years, plasma medicine has developed into an innovative field of research showing high potential. While thermal plasmas have long been used in various medical fields (for instance for cauterization and sterilization of medical instruments), current research mainly focuses on application of non-thermal plasmas. Experiments show that cold atmospheric plasmas (CAPs) allow efficient, contact-free and painless disinfection, even in microscopic openings, without damaging healthy tissue.

Plasma applications in medicine with a special focus on dermatology.

The recent tremendous progress in understanding physical plasma phenomenon, together with the development of new plasma sources has put growing focus on the application of plasmas in health care. Active plasma components, such as molecules, atoms, ions, electrons and photons, reactive species, ultraviolet radiation, optical and infrared emission and heat have the ability of activating, controlling and catalysing reactions and complex biochemical procedures. Thermal and non-thermal (i.

A first prospective randomized controlled trial to decrease bacterial load using cold atmospheric argon plasma on chronic wounds in patients.

Background: Bacterial colonization of chronic wounds slows healing. Cold atmospheric plasma has been shown in vitro to kill a wide range of pathogenic bacteria. Objectives To examine the safety and efficiency of cold atmospheric argon plasma to decrease bacterial load as a new medical treatment for chronic wounds.