TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis...
Moderate-to-severe Atopic DermatitisAbout 60% of all patients with AD are adults. However, the prevalence and incidence is significantly higher in childhood and adolescence. Some children, adolescents and adults with moderate-to-severe AD cannot be sufficiently controlled with topical treatments alone and require intermittent or continuous treatment with systemic immunomodulating agents or UV-therapy. Systematic reviews indicate that although several different interventions for moderate-to-severe AD have been studied in clinical trials, strong recommendations are only possible for Dupilumab in adults and the short-term use of cyclosporin A (CSA). Pharmaceutical treatment of patients suffering from AE is diverse and frequently not in line with the current guidelines (for example S2-guideline in Germany). Large head-to-head trials are missing so that long-term effectiveness of systemic interventions for moderate-to-severe AD is speculative. In this situation, clinical registries can provide valuable information for evidence-based clinical decision making. Extension of TREATgermany to children and adolescents is necessary as moderate-to-severe AD is frequent in this age group, but the effectiveness of existing topical and systemic agents in the routine care setting on clinical severity, patient-reported outcomes, and the course of AD and associated atopic and non-atopic comorbidities over time is still poorly understood it is unclear how many children and adolescents cannot be effectively controlled with the avoidance of trigger factors, patient education, and topical anti-inflammatory treatment alone innovative agents will become available for these age groups within the next years and reference data will be necessary to evaluate their effectiveness and indication criteria adequate evidence regarding patient needs in children and adolescents with moderate-to-severe AD is urgently needed to provide value-based healthcare for this vulnerable patient group Best-practice models of transition from adolescent to adult care of patients with moderate-to-severe AD do not exist yet, but constitute a prerequisite for the establishment of efficient patient care
Ultrasonic Perfusion Imaging in Post-mastectomy Irradiated Patients
Breast ReconstructionRadiation Dermatitis2 moreThe purpose of this study is to evaluate post-mastectomy breast skin blood supply (perfusion) after radiation therapy, and before and after fat grafting to the breast(s).
The Role of Interleukin-1 Beta Targeted Therapy for Patients Suffering From Allergic Contact Dermatitis...
Allergic Contact DermatitisThe study will investigate if Anakinra can ameliorate allergic contact dermatitis in participants with known nickel allergy
NiPPeR Randomised Trial - Child Follow Up Study
ObesityChildhood12 moreThere is an increasing focus on the need to optimise nutrition, lifestyle and metabolism of parents before and during pregnancy and of the infant after birth, but as yet there is limited understanding of the specific influences and of the underlying mechanisms. This study is a follow up of children from the NiPPeR trial of a nutritional drink enriched with micronutrients, myo-inositol and probiotics taken preconception and during pregnancy. In this setting we will examine the influence of parental nutrition, lifestyle and metabolism before and during pregnancy on child growth, development and well-being; ascertaining growth, adiposity, metabolism, neurobehavioural and health outcomes in the children, and characterising the underlying mechanisms. The data collected will allow identification of the contributions of parental and offspring characteristics, nutritional, lifestyle and medical factors, social and economic status, ethnicity, genetics, metabolism and microbes to promoting healthy growth, body composition and wellbeing in the children.
Dupixent and Narrowband UVB for Atopic Dermatitis
Atopic Dermatitis24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.
Skin Efficacy and Tolerability of a Cosmetic Product Combination Over 3 Months in Subjects With...
Atopic DermatitisEczema-Prone SkinThe aim of this exploratory study is to investigate the short- and long-term efficacy and tolerability of a cosmetic product combination consisting of a body lotion and an intensive care product in subjects with atopic eczema over 3 months of use. Efficacy is assessed by instrumental measurements of skin condition (sub-panel), clinical examinations, and questionnaires.
A Study of a Probiotic Food Supplement Containing B. Infantis (EVC001) in Healthy Breastfed Infants...
HealthyThe purpose of this study is to assess the effect of B. infantis (EVC001) versus placebo supplementation, in healthy breastfed infants at risk of developing atopic dermatitis (AD), on cumulative incidence of physician-diagnosed AD during the first year of life.
Eucrisa for Atopic Dermatitis
Mild to Moderate Atopic DermatitisPatients with mild to moderate atopic dermatitis will be asked to participate in helping the study team determine how well the medication works for atopic dermatitis. Participants will not be told that adherence will be monitored. Patients will be dispensed topical crisaborole 2% ointment (Eucrisa®) in a medication tube fitted with a Medication Event Monitoring System (MEMS) cap if they agree to participate. This cap records dates and times the bottle is opened and this data can be downloaded and tabulated with the associated software. Investigators and subjects will be blinded to the adherence data until the final treatment (12 month) session. The study subjects will be randomized to two groups. After baseline visit, both groups will come for a follow-up visit at 1 month, 3 months, 6 months, and 12 months. The intervention group will also be asked to complete an online treatment response survey designed to improve adherence at weekly intervals for 6 weeks, then monthly thereafter. The study will consist of a 12-month Treatment Phase. Study subjects will be instructed to apply the medication twice daily (morning and evening) to all of their AD lesions. They will be instructed to apply the smallest amount of study medication possible that is sufficient to cover all lesions. These instructions are standard-of-care for patients with AD. Subjects will be asked to bring their medication tubes with them at each visit. At each visit, the study coordinator will weigh the medication tube and download the MEMS cap data. Disclosure of the adherence monitoring will occur at the 12 month visit (or end of treatment), at which time the results of the subject's adherence behavior will be used to supply individualized treatment options for each subject (feedback session). At each visit, drug tubes will be measured for weight to determine the amount of study medication used. This data will be correlated with the extent of BSA involved and the response of the disease. The MEMS caps will be downloaded at each visit.
Nutrients-fortified Egg Consumption on Eczema Condition in Individuals With Eczema
EczemaAtopic3 moreThe study aims to assess the effects of daily consumption of nutrients-fortified eggs on eczema condition in individuals with eczema. It is hypothesised that daily consumption of nutrients-fortified egg, which is rich in antioxidants, will improve eczema conditions in individuals with eczema as compared to consumption of regular eggs.
Xerosis and Use of Topical Moisturizer
Xerosis Due to Atopic DermatitisThe primary hypothesis is that routine measurement of trans epidermal water loss (TEWL) rates and stratum corneum (SC) hydration levels will promote patient adherence to maintenance moisturizer therapy and prevent disease relapse. The project will consist of a trial in which thirty subjects with xerosis receive moisturizer therapy and are randomized to receive either no intervention, a weekly electronic survey to assess patient's response to daily moisturizer, or daily monitoring of the effectiveness of a moisturizer with a portable hydration measurement device. The study team will measure adherence to daily moisturizer use objectively in all three groups with electronic monitors attached to the containers of the moisturizer. The adherence measure will allow the study determine how well moisturizers work for xerosis when that are well used. The study team anticipate that in the no intervention group, adherence will be abysmal and that in the group reporting their response to treatment weekly, adherence will be much better. This will give the study team negative and positive controls for assessing the effect of home barrier monitoring on treatment adherence.