A Topical Treatment Optimization Programme (TTOP) improves clinical outcome for calcipotriol/betamethasone gel in psoriasis: results of a 64-week multinational randomized phase IV study in 1790 patients (PSO-TOP).

Background: Around two-thirds of patients with psoriasis do not adhere to topical treatment. The Topical Treatment Optimization Programme (TTOP), a five-element tool, includes guidance for the conversation between dermatologists/nurses and patients, patient information material, telephone/e-mail helpdesks and treatment reminders. It has been developed by patients and dermatologists to help increase adherence to treatment in psoriasis.

Evaluation of adherence predictors for the treatment of moderate to severe psoriasis with biologics: the importance of physician-patient interaction and communication.

Background: Treatment efficacy of biologic agents in moderate to severe psoriasis is regarded as high with patient adherence being higher than for traditional therapies. However, use of biologics is connected to high discontinuation rates. The current investigator-initiated study was conducted to improve the understanding of adherence.

Wirksamkeit und Sicherheit von Fumarsäureestern in Kombination mit Phototherapie bei Patienten mit moderater bis schwerer Plaque-Psoriasis (FAST).

Hintergrund: Die Behandlung von Psoriasis-Patienten mit einer Kombination aus Fumarsäureestern (FSE, Fumaderm ) und Phototherapie (UV) ist verbreitet, wurde aber im Rahmen von Studien wenig untersucht. Bisher liegen lediglich Daten aus einer kleinen Pilotstudie vor. Intention dieser Studie war, eine FSE/UV-Kombinationsbehandlung an einem größeren Patientenkollektiv mit mittelschwerer bis schwerer Psoriasis zu untersuchen.

Efficacy and safety of fumaric acid esters in combination with phototherapy in patients with moderate-to-severe plaque psoriasis (FAST).

Background: While treatment of patients with moderate-to-severe psoriasis using a combination of fumaric acid esters (FAE, Fumaderm ) and phototherapy (UV) is common practice, there have been hardly any studies investigating this regimen. Available information is limited to data from a small pilot study. The objective of the present study was to evaluate FAE/UV combination therapy in a larger patient cohort with moderate-to-severe psoriasis.

An intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis (METOP): a 52 week, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial.

Background: Methotrexate is one of the most commonly used systemic drugs for the treatment of moderate to severe psoriasis; however, high-quality evidence for its use is sparse and limited to use of oral dosing. We aimed to assess the effect of an intensified dosing schedule of subcutaneous methotrexate in patients with moderate to severe plaque-type psoriasis.

Methods: We did this prospective, multicentre, randomised, double-blind, placebo-controlled, phase 3 trial (METOP) at 16 sites in Germany, France, the Netherlands, and the UK.

FamilyPso - a new questionnaire to assess the impact of psoriasis on partners and family of patients.

Background: Psoriasis is a lifelong disease for which there is no cure. It has been conclusively shown across all ethnicities that patients suffering from psoriasis have a significantly reduced health-related quality of life and a high disease burden.

Objective: Surprisingly little is known about the impact of a patient's psoriasis on partners or family members.

Retrospective data collection of psoriasis treatment with fumaric acid esters in children and adolescents in Germany (KIDS FUTURE study).

Background: Given that there is no standard systemic treatment for children and adolescents with plaque psoriasis, this non-interventional, multicenter, retrospective study collected data on the efficacy and safety of long-term treatment with fumaric acid esters (FAEs) in this particular patient group.

Patients And Methods: In patients younger than 18 years of age at the start of FAE treatment, data on efficacy and safety was retrospectively collected for at least 36 months.

Results: Data from 127 patients (aged 6-17 years) was collected for treatment durations of up to 60 months.

IncobotulinumtoxinA for the treatment of platysmal bands: a single-arm, prospective proof-of-concept clinical study.

Background: IncobotulinumtoxinA improves the appearance of facial rhytides and the aging neck.

Objective: To investigate the efficacy, safety, and subject satisfaction of incobotulinumtoxinA for platysmal band treatment.

Methods: Subjects (n = 23) with 2 to 4 platysmal bands (scoring ≥1 on a newly validated 5-point assessment scale) were enrolled.

Efficacy of a fixed combination of calcipotriol/betamethasone dipropionate topical gel in adult patients with mild to moderate psoriasis: blinded interim analysis of a phase IV, multicenter, randomized, controlled, prospective study.

Background: Psoriasis is a common, chronic, inflammatory skin disease with the majority of individuals having limited disease, treated with topical medication. However, special attributes of topical treatments like galenic/cosmetic properties or an inconvenient treatment schedule may result in low preference for topical treatments. Hence, there is strong medical need for a topical medication, which is highly efficacious, easy-to-use and preferred by both physicians and patients.

Development of an adherence-enhancing intervention in topical treatment termed the topical treatment optimization program (TTOP).

Psoriasis is a common, disabling, chronic, relapsing, inflammatory disorder of the skin with a worldwide prevalence of 2-3 % in which adherence to treatment is often poor. The majority of individuals have limited disease that is being treated with topical medication according to existing guidelines. Adherence rates are lower for topical compared with systemic treatment.

Non-adherence and measures to improve adherence in the topical treatment of psoriasis.

Psoriasis is a chronic, recurrent immune-mediated skin disease with a 2-3% prevalence in the Western population, which severely affects patients' quality of life and poses a considerable socioeconomic challenge. The majority of individuals have psoriasis in limited areas and topical products are the mainstay of therapy according to existing guidelines. It is known that medication adherence rates are lower for topical treatment than for systemic treatment.

Assessing adherence factors in patients under topical treatment: development of the Topical Therapy Adherence Questionnaire (TTAQ).

Medication adherence rates strongly depend on favorable disease outcomes. It is known that medication adherence rates are lower for topical treatment than for systemic treatment. However, to date no validated instrument for the assessment of adherence factors in topical treatment is available.

Onset, longevity, and patient satisfaction with incobotulinumtoxinA for the treatment of glabellar frown lines: a single-arm, prospective clinical study.

Background: IncobotulinumtoxinA (Bocouture(®)) is free from complexing proteins and effective for treating glabellar frown lines.

Purpose: To determine the efficacy, onset, and duration of action of incobotulinumtoxinA for the treatment of glabellar frown lines.

Patients And Methods: In this single-arm, prospective, proof-of-concept study, 23 patients were treated with 25 U incobotulinumtoxinA, equally split between five injection sites in the glabella.

Prospective validation of the "rhino conjunctivitis allergy-control-SCORE©" (RC-ACS©).

Background: Recently we reported the validation of the "Allergy-Control-SCORE© (ACS)" which assesses symptom severity as well as medication use on three dimensions lung, nose and eyes. The aim of this study was to test the validity of the score for eyes and nose.

Methods: One-hundred-twenty-one consenting subjects (age 19-65y), including 81 patients with allergic rhino-conjunctivitis (RC) and 40 healthy controls, participated in the study.

A prospective, split-face, randomized, comparative study of safety and 12-month longevity of three formulations of hyaluronic acid dermal filler for treatment of nasolabial folds.

Background: Data regarding several hyaluronic acids (HAs) used identically for facial tissue augmentation have heretofore been unavailable.

Objectives: This prospective, split-face, randomized, two-armed study sought to determine the long-term safety and effectiveness of three HAs (HA-1 (Belotero Basic/Balance), HA-2 (Restylane), and HA-3 (Juvéderm Ultra 3/Juvéderm Ultra Plus XC) in the treatment of nasolabial folds (NLFs).

Methods: Twenty participants in Arm A received HA-1 in one NLF and HA-2 in the other.

Benefit evaluation in the therapy of chronic wounds from the patients' perspective--development and validation of a new method.

Assessing therapeutic benefit of any drug and medical device is essential in registration and cost reimbursement decisions in Germany and in many nations. In this study, a method for the assessment of patient-relevant benefits in wound therapy was developed and validated. A total of 83 items on treatment benefit from the patients' perspective were collected in an open survey, including n = 50 patients with chronic wounds.

Local anesthetic effects of Lidocaine cream: randomized controlled trial using a standardized prick pain.

Background: ELA-max (4% lidocaine) and EMLA cream (lidocaine-prilocaine 2.5%) are topicals used for superficial anesthesia. Only few studies have been published on their comparative effectiveness in close-to-practice pain models.

[Treatment of crow's feet with two different botulinum toxin type A preparations in split-face technique].

Background: For the first time, the effectiveness of Xeomin®, and Dysport® in an dose-ratio of 1:3 treating crow's feet (FWS 2-3) was evaluated in a double-blind randomized pilot study.

Patients And Method: Xeomin® (12 units) was compared to Dysport® (36 units) in an intra-individual split-face technique in 22 patients over a period of 4 months. According to the facial-wrinkle-scale (FWS) patients were rated as responders with an improvement of at least 1 point in FWS.

Comparison of two botulinum toxin type A preparations for treating crow's feet: a split-face, double-blind, proof-of-concept study.

Background: This is the first double-blind, randomized, proof-of-concept study to compare the clinical effectiveness of botulinum toxin type A (BoNTA) free of complexing proteins with a BoNTA complex (BTXCo) in the treatment of crow's feet.

Patients And Method: Twelve U of each product were compared in an intra-individual study in 21 participants with a facial wrinkle scale (FWS) score of 2 to 3. Evaluations were done for up to 4 months.

Quality of life evaluation in wounds: validation of the Freiburg Life Quality Assessment-wound module, a disease-specific instrument.

Many patients with chronic wounds suffer not only directly from their wounds but also from high financial, social and psychological impairments, significantly reducing their quality of life. In order to provide an instrument both applicable to different patient populations and sensitive to areas of impact specific to certain skin diseases, the modular instrument 'Freiburg Life Quality Assessment' has been developed. Each disease-specific version of the instrument consists of a core module of generic items and items specific for a distinct skin disease.

[Does dilution have an impact on cosmetic results with BoNT/A? Complex-protein-free BoNT/A for treatment of glabella lines].

Background: In this 2-armed, randomized study we investigated the efficacy and tolerability of complex-protein-free botulinum neurotoxin type A (BoNT/A), applied in two different dilution volumes for treatment of glabellar lines.

Patients And Methods: 40 patients with grade 2-3 glabellar lines (Facial Wrinkle Scale) received treatment with 25U BoNT/A (Xeomin). 100U of botulinum neurotoxin were diluted in 2.

The patient benefit index: a novel approach in patient-defined outcomes measurement for skin diseases.

Evaluation of therapeutic benefits from the patient's perspective is important in medical decision-making and reimbursement. This study aimed at developing and validating an instrument on patient-defined needs and benefits in dermatology. The questionnaire was developed according to international guidelines.

Silica gel is as effective as acyclovir cream in patients with recurrent herpes labialis: results of a randomized, open-label trial.

Objective: To compare silica gel with acyclovir cream in the treatment of recurrent herpes labialis.

Methods: In this randomized, open-label, comparator-controlled trial, 74 patients with recurrent herpes labialis applied silica gel or acyclovir cream respectively over a period of 10 days. The treatment started within 24 hours of the first symptoms of a new recurrence.

Development and validation of a new instrument for the assessment of patient-defined benefit in the treatment of acne.

Background: Benefit assessment of drugs and medical products has become a legally established feature of medical research. A standardized assessment of benefits using scientifically sound and valid methods is essential.

Objective: Development, validation and practical evaluation of an instrument to record patient benefit in treatment of acne.

[Efficacy and benefit of a 5-FU/salicylic acid preparation in the therapy of common and plantar warts--systematic literature review and meta-analysis].

Background: (1) Salicylic acid (SA) and 5-Fluorouracil (5-FU) are effective drugs in wart therapy. (2) In Germany, increasing data on the benefit and the economic efficiency of drugs at Level I of evidence-based medicine are needed.

Methods: Evaluation of the effectiveness and benefits of a drug combination containing 0.