[Drug therapy safety during pregnancy and breastfeeding].

The treatment of dermatological diseases during pregnancy and breastfeeding poses particular challenges for the therapist for medical and legal reasons. Maternal and fetal influencing factors must be taken into account and the special need for protection of the fetus, infant, and mother must be considered in the treatment decision, usually outside of the approval process. Due to the lack of or insufficient evidence for most therapies during pregnancy and breastfeeding, an individual risk-benefit assessment should always be carried out, which also takes into account the risk of nontreatment.

[Modern topical drugs-new developments in galenics and pharmacology].

The importance of topically applied pharmaceuticals, especially for the treatment of dermatological diseases, is still essential. Thanks to detailed knowledge of the organisation and function of the physicochemical barrier of the skin, new galenic concepts have increasingly been developed to market maturity in recent years. Colloidal drug carrier systems in particular, but also targeted physicochemical modifications of matrices are used to optimise the cutaneous bioavailability of topically applied drugs.

[Variants of biotechnological drugs in dermatology : Status quo and future].

Biotechnological drugs, so-called biopharmaceuticals, have complex structures, have special physicochemical characteristics and are subject to special regulatory laws. In addition to recombinant monoclonal antibodies, proteins and fusion proteins, a large number of biotechnological variations have been developed, of which antibody fragments, nanobodies, peptides, and antibody-drug conjugates in particular have found their way into clinical application. In addition to strategies for the treatment of oncological diseases, chronic inflammatory diseases in particular are being addressed, which are also becoming of great importance in dermatology.

Discussion of EMA Draft Guideline on Quality and Equivalence of Topical Products Based on Comparison of Approved Mometasone Furoate Drugs.

Introduction: Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) published a draft guideline on quality and equivalence of topical products, which includes request parameters regarding the quality of the newly developed generic product and test protocols for the implementation of equivalence tests regarding efficacy.

Methods: To date, no data are available on the quality and evidence of the proposed test conditions.

Combination therapy for Sneddon syndrome to reduce the incidence of cerebrovascular complications.

Background: Sneddon syndrome is an occlusive vasculopathy that presents clinically with generalized livedo racemosa on the skin and transient ischemic attacks, strokes, and cognitive or motor deficits in the central nervous system. Antiplatelet or anticoagulant therapy is recommended. Due to the limited therapeutic efficacy and the resulting serious complications, we propose combination therapy with additional infusion cycles of alprostadil and captopril and report initial long-term results.

Delivery of small hydrophilic molecules across the stratum corneum: Identification of model systems and parameters to study topical delivery of free amino acids.

Free amino acids (FAAs) constitute the largest component (∼40 %) of the so-called natural moisturizing factors of the skin. Their level declines in dry skin conditions and one strategy to overcome this problem may involve the topical delivery of FAAs through appropriate strategy. The objective of the present study was therefore to identify alternative skin models and study the corneocyte-water partition coefficients (K) and permeation coefficient (K) of 18 FAAs.

Secukinumab in adult patients with lichen planus: efficacy and safety results from the randomized placebo-controlled proof-of-concept PRELUDE study.

Background: Patients with lichen planus (LP) refractory to available therapies often experience a high disease burden, representing a population with a clear unmet need for new treatments.

Objectives: To evaluate the efficacy and safety of secukinumab 300 mg over 32 weeks in adult patients with biopsy-proven cutaneous LP (CLP), mucosal LP (MLP) or lichen planopilaris (LPP) that is inadequately controlled by topical corticosteroids.

Methods: PRELUDE was a randomized double-blind placebo-controlled phase II proof-of-concept study that enrolled patients with CLP, MLP or LPP.

Delivery of free amino acids into and through the stratum corneum of the skin using micro emulsions and microemulsion-based hydrogels: Formulation, characterization, and ex- permeation studies.

Free amino acids constitute the largest portion (40%) of the natural moisturizing factor. Their level might decline and cause dry skin condition. The treatment strategy involves the replenishment of these components to the skin, and, to our knowledge, there are no reports that involve dermal delivery of free amino acids.

[Practical problems with the use of topicals in geriatric dermatology].

Changes related to aging affect all layers of the skin and are influenced by both intrinsic conditions and extrinsic factors. The extent of the senescent changes can vary enormeously in seniors, so that an individual assessment is useful and often necessary. Of particular clinical importance are changes in the epidermis, which entail a complex reduction of the barrier function and a reduction in the compensatory capacity with regard to exogenous noxae.

Recommendations for risk minimization when using Janus kinase inhibitors for the treatment of chronic inflammatory skin diseases.

In accordance with article 20 of Regulation (EC) No 726/2004, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has re-evaluated the safety of Janus kinase inhibitors for the treatment of inflammatory diseases and formulated safety information deviating from the previous indications in the respective summary of product characteristics of the products concerned. These refer to the consideration of a possibly increased risk of venous thromboembolic or severe cardiovascular events, an increased infection rate and an increase in the prevalence of skin cancer across drugs and indications. Therefore, in patients with independent risk factors (age 65 years and older, smokers or former smokers, patients with oral contraception or hormone replacement therapy and other risk factors), it is recommended to use Janus kinase inhibitors therapeutically only if there are no suitable treatment alternatives.

Epilation and depilation in the genital area - motivation, methods, risks and recommendations from a dermatological point of view.

Pubic hair removal is a body modification practice done worldwide for different socio-cultural reasons, which is more common in women than in men, more common in younger than in older people, and more common in sexually active people than in abstinent individuals. Since there is no medical indication for genital epilation and depilation, with a few exceptions, there is only very limited evidence in the literature about the methods used and their risks. In order to provide users with guidance from a dermatological perspective on the use of different procedures and associated risks, the existing data were collected, analyzed and evaluated in a systematic literature search.

Efficiency of cutaneous heat diffusion after local hyperthermia for the treatment of itch.

Background: Today, itching is understood as an independent sensory perception, which is based on a complex etiology of a disturbed neuronal activity and leads to clinical symptoms. The primary afferents (pruriceptors) have functional overlaps with afferents of thermoregulation (thermoceptors). Thus, an antipruritic effect can be caused by antagonizing heat-sensitive receptors of the skin.

[Recommendations for individual comorbidity risk assessment in adult patients with psoriasis].

It has long been known that chronic inflammatory systemic diseases, such as psoriasis, pose a high risk of developing comorbidities. In everyday clinical practice, it is therefore of particular importance to identify patients who have an individually increased risk profile. In patients with psoriasis, the comorbidity patterns "metabolic syndrome", "cardiovascular comorbidity" and "mental illness" were identified as particularly relevant in epidemiological studies depending on the duration and severity of the disease.

[Impact of preservatives in topicals on the cutaneous microbiota].

Preservatives are used to stabilize topical preparations and protect the user from the influence of pathogenic microbes. After the application of a topical preparation, the matrix undergoes a metamorphosis, and by proportional evaporation of the hydrophilic phase the preservative may accumulate on the skin surface. This is believed to lead to antiseptic effects and may influence the diversity of the cutaneous microbiota.

Permethrin Steal Effect by Unmasked Corneocytic Keratin in Topical Therapy of Scabies.

Introduction: The use of epicutaneously applied permethrin in the treatment of common scabies is considered to be the first-line therapy. Due to increasing clinical treatment failure, the development of genetic resistance to permethrin in Sarcoptes scabiei var. hominis has been postulated.

Hyperhidrosis: A Central Nervous Dysfunction of Sweat Secretion.

Hyperhidrosis (HH) is a central nervous dysfunction characterized by abnormally increased sweating due to a central dysregulation of sweat secretion. HH significantly affects the quality of life of patients in their private, social and professional environments. Physiologically, sweating is a mechanism that regulates body temperature, but it may also be triggered by emotional or gustatory stimuli.

Supersaturation as a Galenic Concept for Improving the Cutaneous Bioavailability of Drugs in Topical Therapy.

The essential force that allows an epicutaneously applied drug to penetrate the skin is mediated by diffusion. The physicochemical properties of the skin tissue at the site of application and the concentration gradient of the dissolved drug between the vehicle and the stratum corneum are decisive here. One way to specifically improve these diffusion conditions is to use supersaturation.

Pharmakologie der Januskinase-Inhibitoren - Teil 2: Pharmakodynamik: Pharmacology of inhibitors of Janus kinases - Part 2: Pharmacodynamics.

Als niedermolekulare Substanzen haben die Januskinase-Inhibitoren unterschiedliche, dosisabhängige pharmakologische Bindungsselektivitäten, die allerdings keine verlässlichen Aussagen über die klinische Spezifität gewünschter oder unerwünschter Wirkeffekte ermöglichen. Es ist deshalb von besonderer Bedeutung zu erkennen, dass die Pharmakodynamik der einzelnen Januskinase-Inhibitoren in Abhängigkeit der behandelten Indikation wesentlich durch die variablen Regulationsebenen des JAK/STAT-Signalwegs sowie der pharmakokinetischen Bedingungen bestimmt wird. Vor diesem Hintergrund wird deutlich, dass alleinig klinische Studiendaten in definierten Indikationen für die Bewertung der Wirksamkeit und Sicherheit von Januskinase-Inhibitoren geeignet sind.

Pharmacology of inhibitors of Janus kinases - Part 2: Pharmacodynamics.

As small molecules, the Janus kinase inhibitors have different, dose-dependent pharmacological binding selectivities, which, however, do not allow reliable statements about the clinical specificity of desired or side effects. It is therefore of particular importance to recognize that the pharmacodynamics of the individual Janus kinase inhibitors as a function of the treated indication is essentially determined by variable levels of regulation of the JAK/STAT signaling pathway and the pharmacokinetic conditions. Against this background, it becomes clear that only clinical trial data in defined indications are suitable for evaluating the efficacy and safety of Janus kinase inhibitors.