Active clinical trials for "Dermatitis, Atopic"

Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system. Breastfed infant is beneficial to prevent the occurrence of infantile colic (IC) and atopic dermatitis (AD), which may through shaping a healthy microbiota. However, the gut microbiota biomarkers representing IC and AD have not yet been discovered. In addition, the effectiveness of supplement of HMO in infant formula reduce the incidence of IC and AD in infants is still debate.

This study is parallel group, placebo-controlled dose-ranging study to evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of GSK1070806 in adult participants with moderate to severe Atopic Dermatitis (AtD), who have previously been treated with medicated topical treatments or a biologic therapy.

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how effective upadacitinib is in treating AD. Upadacitinib is an approved drug for treating AD. Approximately 300 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in France. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

This is a Prospective, non-interventional (NIS) observational study in patients (≥6 years) with atopic dermatitis (AD) receiving dupilumab for the prospective evaluation of signs and symptoms, quality of life and disease control. The aim of this NIS is the characterization of the AD patient population in Germany, receiving dupilumab under everyday conditions in terms of their medical history, socio-demographic and disease-related characteristics, associated atopic comorbidities and type 2 inflammation diseases, concomitant therapy as well as previous systemic and ongoing AD treatments. In addition to the therapeutic response rate at Month 6, the long-term efficacy of dupilumab at Month 12 and Month 24 will be assessed by additional outcomes by measuring disease control in AD patients using questionnaires such as Atopic Dermatitis Control Tool (ADCT) and Recap of Atopic Eczema (RECAP). In addition, this NIS aims to assess the dosing pattern of dupilumab for AD, including variations in dosing regimen, reason for dupilumab treatment initiation or discontinuation, or change in therapy and concomitant therapies and duration of treatment. In addition, the effect of dupilumab in adult and pediatric AD patients with associated atopic comorbidities or type-2 inflammation diseases are observed, which corresponds to the clinical care situation. Finally, this NIS aims to collect long-term safety data in adult, adolescent and pediatric AD patients treated with dupilumab. Individual observation period is 2 years or until dupilumab is discontinued. Visits will be scheduled according to standard of care.

Study Description: This is a double-blind, randomized, phase 3 clinical trial for a topical formulation of a live biotherapeutic containing Roseomonas mucosa combined with ground cardamom seeds in a sucrose solution for patients with atopic dermatitis (AD). Participants will reconstitute the dried product in water and apply topically 2 or 3 times per week for 14 weeks. After 14 weeks, all interventions will cease, and participants will be followed for an additional 14 weeks to assess how long treatment effects last. During the course of study, we will assess disease severity (eg, itch, rash, and quality of life [QOL]) using a variety of AD assessments, ease of compliance with treatment, and changes in the microbiome profile of the skin. We hypothesize that topical treatment with Roseomonas mucosa, combined with ground cardamom seeds, will provide significantly more alleviation in AD symptoms than placebo, and that these effects will last beyond active treatment (due to the ability of the bacteria to colonize the patients' skin). Primary Objective: To determine if R mucosa combined with ground cardamom seeds can improve symptoms of AD in patients aged 2 and older, 14 weeks after treatment discontinuation. Secondary Objective: To determine if R mucosa combined with ground cardamom seeds can improve the Investigator s Global Assessment (IGA) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion. To determine if R mucosa combined with ground cardamom seeds can improve the Numerical Rating Scale (NRS) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion. To determine if R mucosa combined with ground cardamom seeds can improve the SCORing Atopic Dermatitis (SCORAD) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion. To determine if R mucosa combined with ground cardamom seeds can improve the Patient-Oriented Eczema Measure (POEM) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion. To determine if effects of R mucosa combined with ground cardamom seeds on the symptoms of AD differ by levels of pollution near home of residence. To determine if use of R mucosa permits less use of topical steroid treatments. To determine the safety of R mucosa use. Exploratory Objectives: To determine if patients and caregivers using topical R mucosa understand the instructions and precautions for use. To determine if topical R mucosa with cardamom seeds alters the skin microbiome profile during and after treatment. To determine if topical R mucosa colonizes the skin of patients during use. Primary Endpoint: Proportion of participants achieving a 90% improvement in Eczema Areav and Severity Index (EASI90; a measure of eczema rash) from baseline(week 0) to study completion (week 28). Secondary Endpoints: Proportion of adverse events (AEs). Mean number of average weekly topical steroid use over the study follow up. Change and percent change in IGA (a measure of eczema rash) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28). Change and percent change in NRS (subjective measure of itch) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28). Change and percent change in SCORAD (a combined metric of eczema itch, rash, QOL) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28). Change and percent change in QOL measures, POEM, from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28). Proportion of participants achieving a 90% improvement in EASI90 (a measure of eczema rash) from baseline (week 0) to study completion (week 28) in the high-pollution areas and low-pollution areas. Exploratory Endpoints: Accuracy of identifying correct answers to questions about product applications and precautions. Qualitative input regarding ease of use of product. Presence of treatment strain of R mucosa as assessed by genetic detection (using polymerase chain reaction [PCR] primer). Change in skin microbiome profile during and after treatment.

The aim of this study is to investigate the clinical therapeutic effects of a mixed Chinese herbal formula (CHF) in treating atopic dermatitis (AD) based on its effects on cytokine levels and immune cell counts. Th1/Th2/Th17/Th22-related cytokines will be assayed to determine the mechanisms of the anti-inflammatory and immunomodulatory effects of the mixed CHF in AD patients. The nature of the microbiome dysfunction underlying this disease will be explored. Investigators will also apply a metabolomics approach to reveal the plasma metabolites in AD patients of different TCM patterns as well as to monitor changes of plasma metabolome in AD patients under mixed CHF treatment, aiming to develop metabolic biosignatures for efficacy of mixed CHF in AD patients exhibiting specific TCM pattern. PK study will be conducted to exam blood concentration of the prescription in healthy volunteers and AD patients with good or poor drug response. The results will provide evidence for the precision treatment based on different TCM pattens of AD patients. Completion of this integrated project will provide innovative information for future clinical applications.

About 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

24 weeks open-label study with dupilumab and narrowband UVB phototherapy three times weekly for 12 weeks followed by 12 weeks of dupilumab monotherapy.

The 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.

The 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.