[Decision criteria and patient characteristics for patient-oriented treatment of field cancerization : Standardized algorithm for personalized treatment concepts]. / Entscheidungskriterien und Patientencharakteristika zur patientenorientierten Therapie der Feldkanzerisierung : Ein standardisierter Bewertungsalgorithmus für individuelle Behandlungskonzepte.

BACKGROUND: Actinic keratosis (AK), which frequently affects larger skin areas (field cancerization), is characterized by chronic course. Weighing therapy-specific advantages and disadvantages of field-oriented therapy for individual patients is challenging. OBJECTIVES: The main objective was the development of patient-oriented decision criteria for the pragmatic classification of field-directed AK treatment options in patients with a predisposition for field cancerization (patient types 1-3). MATERIALS AND METHODS: The development of the decision criteria and patient typology was based on a nominal respectively structured multilevel group process. The developed algorithm was then subsequently applied for the systematic evaluation of field-directed AK therapies. RESULTS: Patient-relevant criteria for the treatment decision included (among others): effectiveness, selectivity, safety, duration of therapy, cosmesis, patient preference and comorbidities. With regard to the decision criteria and patient types in which field therapy was the treatment of choice, daylight photodynamic therapy notably met the requirement profile. CONCLUSION: The definition of patient-relevant and therapy-related decision criteria in AK field therapy allows a systematic yet practice-oriented approach to classify specific treatment options and to derive individual treatment decisions.

Thiamidol containing treatment regimens in facial hyperpigmentation: An international multi-centre approach consisting of a double-blind, controlled, split-face study and of an open-label, real-world study.

OBJECTIVE: Tyrosinase is the rate-limiting enzyme in melanogenesis. Thiamidol is the most potent inhibitor of human tyrosinase out of 50 000 tested compounds. In clinical studies, it was shown to improve facial hyperpigmentation, post-inflammatory hyperpigmentation and age spots significantly. To identify the optimal number of daily Thiamidol applications, we conducted a split-face study comparing the efficacy and tolerability of four-times with two-times daily application. Subsequently, we evaluated the efficacy and tolerability of a typical face care regimen containing Thiamidol in a real-world study. METHODS: The split-face study was double-blind, randomized, controlled, including two Thiamidol containing products (serum and day care SPF 30). The serum was applied twice daily on one half of the face and the day care SPF30 twice-daily on the whole face. The real-world study was open-label, observational, including three Thiamidol containing products (day care SPF 30 in the morning, serum and night care in the evening). In both studies, subjects with mild-to-moderate facial hyperpigmentation applied the products over 12 weeks. Assessments included clinical and subjective grading of hyperpigmentation, skin condition, hemi-/modified MASI, chromameter and clinical photography. RESULTS: In the split-face study (n = 34), hyperpigmentation, skin roughness and hMASI improved all significantly (P < 0.001) versus baseline, with first visible results after two weeks of twice-daily application. The four-times daily application led to significant improvement versus the two-times daily application. In the real-world study (n = 83), all evaluated parameters, including skin condition and chromametry (n = 30), improved significantly (P < 0.001) in comparison with baseline and the corresponding preceding visits. The subjects judged the cosmetic properties of the products positively. In both studies, the products were well tolerated. CONCLUSION: Four-times daily Thiamidol improves facial hyperpigmentation significantly more than two-times daily and is well tolerated by the subjects. The real-world study with a typical face care regimen containing Thiamidol shows improvement of facial hyperpigmentation and confirms tolerability. Furthermore, the data provide evidence for the suitability of this three-product Thiamidol regimen for day-to-day life.

OBJECTIF: La tyrosinase est l'enzyme qui limite le taux de mélanogénèse. Le Thiamidol est le plus puissant inhibiteur de la tyrosinase humaine parmi les 50 000 composés testés. Lors d'études cliniques, il a été démontré qu'il améliore de manière significative l'hyperpigmentation du visage, l'hyperpigmentation post-inflammatoire et les taches de vieillesse. Afin d'identifier le nombre optimal d'applications quotidiennes de Thiamidol, nous avons mené une étude hémi-visage comparant l'efficacité et la tolérance d'une application quatre fois par jour à une application deux fois par jour. Par la suite, nous avons évalué l'efficacité et la tolérance d'un régime de soins du visage typique contenant du Thiamidol dans le cadre d'une étude en situation réelle. MÉTHODES: L'étude hémi-visage était en double aveugle, randomisée et contrôlée, incluant deux produits contenant du Thiamidol (sérum et soin de jour SPF 30). Le sérum a été appliqué deux fois par jour sur une moitié du visage, et le soin de jour SPF30 deux fois par jour sur l'ensemble du visage. L'étude en situation réelle était ouverte, observationnelle, et comprenait trois produits contenant du Thiamidol (soin de jour SPF 30 le matin, sérum et soin de nuit le soir). Dans les deux études, les sujets présentant une hyperpigmentation faciale légère à modérée ont appliqué les produits pendant 12 semaines. Les évaluations comprenaient une évaluation clinique et subjective de l'hyperpigmentation, de l'état de la peau, du hémi/modifié MASI, du chromamètre et de la photographie clinique. RÉSULTATS: Dans l'étude hémi-visage (n = 34), l'hyperpigmentation, la rugosité de la peau et l'hMASI se sont tous améliorées de manière significative (P < 0.001) par rapport à la ligne de base, avec des effets devenus visibles aprés deux semaines d'application deux fois par jour. L'application quatre fois par jour a apporté une amélioration significative par rapport à l'application deux fois par jour. Dans l'étude en situation réelle (n = 83), tous les paramѐtres évalués, y compris l'état de la peau et la chromamètrie (n = 30) se sont améliorés significativement (P < 0.001) par rapport à la ligne de base et aux visites précédentes correspondantes. Les sujets ont jugé positivement les propriétés cosmétiques des produits. Dans les deux études, les produits ont été bien tolérés. CONCLUSION: L'application de Thiamidol quatre fois par jour, améliore l'hyperpigmentation du visage de maniѐre plus significative que deux fois par jour et est bien toléré par les sujets. L'étude en situation réelle avec un régime de soins du visage typique contenant du Thiamidol montre une amélioration de l'hyperpigmentation faciale et confirme la tolérance. En outre, les données fournissent des preuves de l'adéquation de ce régime de trois produits à base de Thiamidol pour le soin quotidien.

Medical needs and major complaints related to pruritus in Germany: a 4-year retrospective analysis using Google AdWords Keyword Planner.

BACKGROUND: It is difficult to estimate the prevalence of acute and chronic pruritus in the population at large due to a lack of affected persons seeking medical assistance. OBJECTIVE: To discover the incidence of pruritus in Germany and determine what the most common related complaints are via an analysis of Google's search volume. METHODS: From June 2013 to April 2017, the Google AdWords Keyword Planner was utilized to select and critically assess relevant keywords for 'pruritus'. RESULTS: Among a total of 13 691 470 German language Google searches on the topic of pruritus, it was found that the most searched for terms included atopic eczema (24.3%) and the layman's term for psoriasis ('Schuppenflechte'; 17.8%), as well as just psoriasis (13.4%). 'Juckreiz', the German word for pruritus, was determined to be only the sixth most searched for term (2.9%). Anal pruritus and pruritus of the entire body comprised the most searched for localizations. The various factors that impact pruritus, particularly skin conditions and disorders, were established to be among the most searched for terms (72.6%). A decreased monthly search volume was associated with the changing seasons; the summertime had the lowest number of searches for pruritus. CONCLUSION: The Google search engine analysis provided insight for this study into the unexpectedly large number of unmet medical needs of those suffering from pruritus within Germany, especially that of specific localizations on the body.

Patient-reported health outcomes in patients with non-melanoma skin cancer and actinic keratosis: results from a large-scale observational study analysing effects of diagnoses and disease progression.

BACKGROUND: Non-melanoma skin cancer (NMSC) and actinic keratosis (AK) are very common among fair-skinned individuals. A disease continuum from AK to squamous cell carcinoma (SCC) has been frequently postulated. AK and NMSC may influence quality of life (QL) of patients, and it can be suspected that disease progression entails a QL reduction. The purpose of this study was to document QL in patients with NMSC and AK using the health-outcome questionnaire EQ-5D-5L. METHODS: The study was designed as a non-interventional, prospective, cross-sectional study. Patients with AK, SCC, basal cell carcinoma (BCC) or multiple diagnoses were enrolled in this study in 29 dermatological centres across Germany. Patients were asked to complete the EQ-5D-5L (compromising EQ Index and EQ VAS), and the dermatologists provided diagnosis, disease history and treatment data. RESULTS: A total of 1184 patients were enrolled and diagnosed as follows: 73% AK, 49% BCC and 17% SCC. 66% had a single diagnosis, 28% two different diagnoses and 6% three different diagnoses. QL was strongly associated with patients' diagnosis. Patients with a single AK diagnosis had significantly higher mean EQ VAS (78) than patients with BCC (74), SCC (72), and BCC plus SCC (69), P < 0.050. When the effects of disease progression were calculated, patients with AK plus SCC reported significantly less mean EQ VAS (71) than patients with a single AK diagnosis (78), P < 0.011. CONCLUSIONS: While rarely being imminently life-threatening, NMSC and AK have an impact on QL as quantified by the EQ-5D-5L. This impact is associated with diagnosis (AK vs. NMSC) and clinical progression (AK vs. AK plus SCC). Both lead to a clear decline in QL. This shows that disease progression is perceived and judged as detrimental by patients and that AK and NMSC should be diligently treated to preserve and restore QL.

Daylight photodynamic therapy versus cryosurgery for the treatment and prophylaxis of actinic keratoses of the face - protocol of a multicenter, prospective, randomized, controlled, two-armed study.

BACKGROUND: Photodynamic therapy with daylight (DL-PDT) is efficacious in treating actinic keratosis (AK), but the efficacy of field-directed, repetitive DL-PDT for the treatment and prophylaxis of AK in photodamaged facial skin has not yet been investigated. METHODS/DESIGN: In this multicenter, prospective, randomized, controlled, two-armed, observer-blinded trial, patients with a minimum of 5 mild-to-moderate AK lesions on photodamaged facial skin are randomly allocated to two treatment groups: DL-PDT with methyl aminolevulinate (MAL) and cryosurgery. In the DL-PDT group (experimental group), 5 treatments of the entire face are conducted over the course of 18 months. After preparation of the lesion and within 30 min after MAL application, patients expose themselves to daylight for 2 h. In the control group, lesion-directed cryosurgery is conducted at the first visit and, in the case of uncleared or new AK lesions, also at visits 2 to 5. The efficacy of the treatment is evaluated at visits 2 to 6 by documenting all existing and new AK lesions in the face. Cosmetic results and improvement of photoaging parameters are evaluated by means of a modified Dover scale. Primary outcome parameter is the cumulative number of AK lesions observed between visits 2 and 6. Secondary outcome parameters are complete clearance of AK, new AK lesions since the previous visit, cosmetic results independently evaluated by both patient and physician, patient-reported pain (visual analogue scale), patient and physician satisfaction scores with cosmetic results, and patient-reported quality of life (Dermatology Life Quality Index). Safety parameters are also documented (adverse events and serious adverse events). DISCUSSION: This clinical trial will assess the efficacy of repetitive DL-PDT in preventing AK and investigate possible rejuvenating effects of this treatment. (Trial registration: ClinicalTrials.gov Identifier: NCT02736760). TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02736760 . Study Code Daylight_01. EudraCT 2014-005121-13.

Consensus statement on prevention and management of adverse effects following rejuvenation procedures with hyaluronic acid-based fillers.

Facial fillers play an important role in the correction of facial changes associated with ageing. They offer quick treatments in the outpatient setting with minimal subsequent downtime that provide predictable, natural-looking, long-lasting results. Adverse reactions after hyaluronic acid injections tend to be mild or moderate and rather temporary. However, as with all injected or implanted biomaterials, severe adverse events can occur and patients must be fully informed of potential risks prior to undergoing treatment. A panel of experts from Germany (D), Austria (A) and Switzerland (CH) developed recommendations, and this study provides the 'DACH Consensus Recommendations' from this group specifically on the use of hyaluronic acid fillers. The aim is to help clinicians recognize potential risks and to provide guidance on how best to treat adverse events if they arise. Contraindications to hyaluronic acid fillers are also detailed, and ways to prevent adverse events occurring are discussed. Hyaluronic acid-based products are claimed to be very close to an ideal tissue augmentation agent; nevertheless, profound medical, anatomical and product knowledge are of paramount importance to minimize the occurrence of adverse reactions.

A randomized, double-blind, phase III, multicentre study to evaluate the safety and efficacy of BF-200 ALA (Ameluz(®) ) vs. placebo in the field-directed treatment of mild-to-moderate actinic keratosis with photodynamic therapy (PDT) when using the BF-RhodoLED(®) lamp.

BACKGROUND: Multiple actinic keratosis (AK) lesions may arise from the cancerization of large, sun-damaged skin areas. Although photodynamic therapy (PDT) is considered the most effective therapeutic option, the efficacy and safety of field treatment of multiple AK lesions with PDT has never before been tested in a pivotal trial. OBJECTIVES: To evaluate the efficacy, safety and cosmetic outcome of BF-200 ALA (a nanoemulsion formulation containing 10% aminolaevulinic acid hydrochloride) combined with the BF-RhodoLED(®) lamp for the field-directed treatment of mild-to-moderate AK with PDT. METHODS: The study was performed as a randomized, multicentre, double-blind, placebo-controlled, parallel-group, phase III trial with BF-200 ALA and placebo in seven centres in Germany. A total of 94 patients were enrolled in this study; 87 were randomized (55 patients received BF-200 ALA, 32 received placebo). Patients received one PDT. If residual lesions remained at 3 months after treatment, PDT was repeated. Illumination was performed with the PDT lamp BF-RhodoLED (635 nm ± 9 nm) until a total light dose of 37 J cm(-2) was achieved. RESULTS: BF-200 ALA was superior to placebo with respect to patient complete clearance rate (91% vs. 22%, P < 0·0001) and lesion complete clearance rate (94·3% vs. 32·9%, P < 0·0001) after a maximum of two PDTs. The confirmatory analysis of all key secondary variables supported this superiority" should not be skipped since this is an important result. Treatment-emergent adverse events (TEAEs) were experienced by 100% of the BF-200 ALA group and 69% of the placebo group. The most commonly reported TEAEs were TEAEs of the application site. The cosmetic outcome was improved in the BF-200 ALA group compared with placebo. CONCLUSIONS: Field-directed therapy with BF-200 ALA and BF-RhodoLED lamp is highly effective and well tolerated for multiple mild-to-moderate AK lesions, providing greatly improved skin quality.

Daylight photodynamic therapy with MAL cream for large-scale photodamaged skin based on the concept of 'actinic field damage': recommendations of an international expert group.

Conventional PDT (c-PDT) is a widely used and approved non-invasive treatment for actinic keratosis (AK). Recent clinical, histological and immunohistochemical observations have shown that c-PDT with methyl aminolevulinate (MAL) may also partially reverse the signs of photodamage. However, pain and the need for special light source equipment are limiting factors for its use, especially in the treatment of large areas. More recently, daylight PDT (DL-PDT) has been shown to be similar to c-PDT in the treatment of AK, nearly painless and more convenient to perform. To establish consensus on recommendations for the use of MAL DL-PDT in patients with large-scale photodamaged skin. The expert group was comprised of eight dermatologists. Consensus was developed based on the personal experience of the experts in c-PDT and DL-PDT, and results of an extensive literature review. MAL DL-PDT for large areas of photodamaged skin was evaluated and recommendations based on broad clinical experience were provided. As supported by evidence-based data from multicentre studies conducted in Australia and Europe, the authors defined the concept of 'actinic field damage' which refers to photodamage associated with actinic epidermal dysplasia, and provide comprehensive guidelines for the optimal use of DL-PDT in the treatment of actinic field damage. The authors concluded that MAL DL-PDT has a similar efficacy to c-PDT at 3-month (lesion complete response rate of 89% vs. 93% in the Australian study and 70% vs. 74% in the European study (95% C.I. = [-6.8;-0.3] and [-9.5;2.4] respectively) and 6-month follow-ups (97% maintenance of complete lesion response) in the treatment of AKs. The authors agree that DL-PDT is not only efficacious but also nearly pain-free and easy to perform, and therefore results in high patient acceptance especially for the treatment of areas of actinic field damage.

[Botulinum toxin in dermatology]. / Botulinumtoxin in der Dermatologie.

Treatment with botulinum toxin (BTX) type A has become increasingly important in various clinical areas in dermatology. Particularly popular is the therapy with BTX for hyperkinetic lines associated with muscles of facial expression in aesthetic dermatology, which is the most frequent wrinkle treatment undertaken worldwide. Therapy with BTX also ranks high in curative dermatology. Injections with BTX are the most effective nonoperative therapy for hyperhidrosis. Common indications for the treatment of hyperkinetic lines with BTX are presented in this publication. Therapy of glabellar lines, which has received regulatory approval, is presented in detail. In the second part, treatment of focal hyperhidrosis with emphasis on axillary hyperhidrosis is addressed. In the hand of the experienced practitioner, treatment with BTX in a suitable area of indication is a very safe and effective procedure that leads to remarkable treatment results, associated with a very high patient satisfaction.