Active clinical trials for "Dermatitis"

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, important information is missing on the use patterns and outcomes with upadacitinib in a real-world setting. Therefore, the purpose of this observational study is to help inform real-world usage patterns regarding the safety and effectiveness and duration of response of upadacitinib in adolescent and adult AD participants >=12 years old in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD. Around 975 adolescent and adult participants who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled worldwide. Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

A clinical characterization of a large cohort of patients with different severities of AD and ocular symptoms/atopic keratoconjunktivitis (AKC). The data will contribute to assess the frequency of complications in order to give a rationale for focused prevention and treatment strategy.

This study aims at evaluating the effect of a topical product on the improvement of quality of life and pain of patients suffering from atopic dermatitis or other skin diseases with dryness or severe xerosis. Patients aged 16 years and over are asked to apply the product once or twice a day for 2 months. They may be prescribed a corticosteroid upon decision of the dermatologist.

As structured and detailed data on the management of AD, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in Switzerland, the planned registry will overcome this gap. It will provide data on the medical care of patients with AD for health care research and allow to study the efficacy and safety of approved and available therapies for AD in daily life.

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.