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154 active trials for Atopic Dermatitis

Sensory Nociceptive Nerve Fibers, Key Regulator of Immune Response Type 2 in Atopic Dermatitis

The skin is innervated by a network of nociceptive sensory neurons (nociceptors) whose primary function is the transmission of pain and pruritus signals to the central nervous system. Their role in atopic dermatitis (AD), characterized by an exacerbated type 2 immune response, is only partially understood. Nevertheless, large amounts of neuropeptides, including substance P (SP), are found in the serum of patients, their level being correlated with the clinical severity of AD. Mast cells (MC) are part of the cells of the immune system residing in the skin. MCs have neuro-receptors of the Mas-related G protein-coupled receptors family (MRGPR) and in particular MRGPRX2 (the receptor for cationic molecules [including SP] for MCs) through which they could communicate in a privileged way. with the nociceptors. Preliminary data obtained in mice show that its mouse orthologue "MrgprB2" is absolutely necessary for the development of type 2 immunity and the pathological characteristics of a preclinical "DA-like" model (manuscript in preparation). The investigators therefore hypothesize that the activation of MCs expressing MRGPRX2 by nociceptors producing SP plays a key role in the development of type 2 inflammation in AD in humans.

Start: May 2019

Evaluate the Efficacy of Using Modified Qing-Ying Decoction in Atopic Dermatitis Children

The study aims to evaluate the clinical efficacy and safety of the modified Qing-Ying Decoction (mQYD) for the treatment of subacute and chronic atopic dermatitis (AD) in children when compared to the placebo control through examining the clinical symptoms, quality of life, gut microbiome, and Chinese medicine body constitution. This is a parallel, randomized, placebo-controlled, double-blind clinical trial. Eligible subjects will be randomly allocated to receive oral mQYD granules or it's placebo granules. Subjects will have 12-week of treatment, and then a 4-week follow-up.

Start: August 2020

The Effectiveness of Antibacterial Therapeutic Clothing Based on Silver or Chitosan as Compared With Non-antibacterial Therapeutic Clothing in Patients With Moderate to Severe Atopic Dermatitis

Since 2000 therapeutic clothing or functional textiles based on silver or chitosan as antibacterial agents were introduced as therapeutics of atopic dermatitis (AD). These agents aim to reduce skin colonization with Staphylococcus (S.) aureus. S. aureus induces further dysregulation of the inflammatory process and increased colonization with S. aureus is correlated with increased AD severity. Based on the theoretical mode of action and clinical experience, we assume a higher effectiveness of antimicrobial therapeutic clothing compared to control therapeutic clothing on reducing AD severity. The goal of this study is to assess the effectiveness of antibacterial clothing based on silver or chitosan on the doctor-reported AD severity in patients with moderate to severe AD. Secondary goals are to retrieve information about the effect of antimicrobial clothing on clinical symptoms, quality of life, S. aureus colonization, AD medication use and the satisfaction regarding the clothing.

Start: March 2020

Study of Skin Microbiome in Atopic Dermatitis Patients

Everybody's skin has bacteria that normally lives on it. Previous research has shown that people with eczema have higher concentrations of a certain bacteria (S. aureus), especially when their disease is active. The purpose of this study is (a) to see if reductions in another skin bacteria (C. acnes) plays a role in the overgrowth of S. aureus in eczema patients, and (b) to examine how the types of bacteria present in the skin of patients with eczema or psoriasis change with disease activity.

Start: April 2019

The Utility of Functionally Relevant Signature Genes in Assessing the Clinical Outcomes of Dupilumab Treatment

The utility of functionally relevant signature genes in assessing the clinical outcomes of dupilumab treatment in the adult onset atopic dermatitis

Start: July 2020

PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter Coupled With Oral Vitamin D Supplementation vs. Placebo

Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients

Start: October 2015

A Phase I/IIa Study to Investigate the GM-XANTHO in Healthy Volunteers and Atopic Dermatitis Patients

A Phase I/IIa Study to Evaluate the Safety, Tolerability and Pharmacokinetics of GM-XANTHO in Healthy Volunteers and to Investigate its Efficacy and Safety Profile in Atopic Dermatitis Patients

Start: May 2020

Early Origins of Allergy and Asthma

Birth cohort study with recruitment during pregnancy to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, asthma, and metabolic conditions in the offspring.

Start: October 2018

Evaluating the Effects of Tradipitant vs. Placebo in Atopic Dermatitis (EPIONE2)

This is a multi-center, randomized, double-blind, placebo-controlled study to be conducted in the United States in subjects with atopic dermatitis.

Start: October 2019

A Phase ? Study of Hemay808 for Atopic Dermatitis Patients

Assess Hemay808 concentration of 1%/3%/7% for treatment of mild and moderate adult atopic dermatitis patients.

Start: April 2020

Vitamin D and Its Receptor Gene Polymorphisms in Lithuanian, Latvian and Taiwanese Patients With Atopic Dermatitis and Asthma

The role of vitamin D is well known in calcium and phosphate homeostasis; however, in addition to traditional functions, vitamin D has an important role in pathogenesis of different allergic diseases, such as asthma, atopic dermatitis (AD), and food allergy. There are evidences that lower cord blood vitamin D status is observed in infants with eczema. More-over, vitamin D level is decreased in subjects with asthma. One of the most important functions of vitamin D is to modulate the immune system response, both innate and adaptive, by suppressing Th2-type response and increasing natural killer cells. Vitamin D induces a higher level of IL-10, which is known as anti-inflammatory cytokine. Other studies have shown that vitamin D contributes to the conversion of CD4+ T cells to T regulatory cells. Recent studies showed that higher serum 25-hydroxyvitamin D level was associated with a reduced risk of asthma exacerbation and hospitalization. Vitamin D can enhance dexamethasone-induced MAP kinase phosphatase-1 (MKP-1) expression in peripheral blood mononuclear cells. Experimental data suggest that vitamin D can potentially increase the therapeutic response to glucocorticoid and can be used as an add-on treatment in steroid-resistant asthmatics. Vitamin D stimulates the production and regulation of skin antimicrobial peptides, such as cathelicidins, which have both direct antimicrobial activity and induced host cellular response by triggering cytokine release. Recent evidence suggests that low blood vitamin D level is a risk factor for food allergy. Vitamin D acts by binding to the vitamin D receptors (VDRs), which are located in a variety of tissues. VDRs have been identified on nearly all cells of the immune system including T cells, B cells, neutrophils, macrophages, and dendritic cells (DCs). Vitamin D deficiency predisposes to gastrointestinal infections by changing gut micro-biota, which may promote the development of food allergy. However the detail mechanism how vitamin D affects or protects the development of allergic diseases is still unknown. Vitamin D level is determined by sun exposure. Due to the fact that Lithuania, Latvia and Taiwan are located in different latitudes of north hemisphere with markedly different sun exposure, in this Joint collaboration study between Taiwan, Lithuanian and Latvia, we are going to study, (1). Serum vitamin D level in children and adults with AD and/or asthma in Lithuania, Latvia and Taiwan. (2). VDRs genetic polymorphisms of AD and/or asthma in children and adults in Lithuania, Latvia and Taiwan. (3). Finally, we would like to explore the gut microbiome of patients with AD and/or asthma in Lithuanian, Latvian and Taiwanese children and adults; and to estimate possible relationship between gut microbiome and vitamin D level and VDRs genetic polymorphisms. We believe that this study will be the first which compares the populations with different geographical and ecological factors having the same allergic diseases. We hope that these results will provide the answer about the role of vitamin D in the prevention, or in the future, in treatment of allergic diseases.

Start: January 2020

Dupilumab Impact on Skin Resident Memory T Cells

The main objective of the study consists in characterizing the immune cells that are present/persist in the skin and the blood of atopic dermatitis (AD) patients treated with Dupilumab, as well as with potent/very potent topical corticosteroids (TCS: betamethasone valerate cream 0.1% or clobetasol propionate cream 0.05%). A specific attention will be paid on the presence/persistence of skin Trm and ILCs. The study population will consist of 20 adult patients suffering from moderate to severe Atopic Dermatitis and eligible for Dupilumab treatment. (Patients should have inadequate response, intolerance or contraindication to systemic anti-inflammatory treatments). This is an exploratory, prospective, single-site, randomized, open labeled study. There is a treatment period of 168 days (24 weeks) and a post-treatment follow-up period of maximum 102 days.

Start: March 2020

Topically Applied AMTX-100 CF for Adult Patients With Mild to Moderate Atopic Dermatitis

This study determines the Maximum Tolerable Dose (MTD) by maximum BSA percentage treated and evaluates efficacy of various concentrations of AMTX-100 CF versus placebo (vehicle). The study has two parts: Phase I (Part 1): Approximately Twenty five (25) subjects with various treatable Body Surface Area (BSA) involvement of Mild to Moderate Atopic Dermatitis will be enrolled in the study and treated with 1.1% w/w AMTX-100 CF. Phase II (Part 2): Approximately One Hundred Twenty (120) subjects with Mild to Moderate Atopic Dermatitis with various treatable BSA involvement of Mild to Moderate Atopic Dermatitis will be randomized to be treated with different concentrations of AMTX-100 CF (low concentration (0.11% w/w), medium concentration (0.33% w/w) and high concentration (1.1% w/w)) or Vehicle (Placebo) in the study.

Start: March 2020

Topical L. Reuteri in Children With Atopic Dermatitis

This study evaluates the safety and efficacy of the probiotic L. reuteri vs control product as an adjuvant for improving the skin appearance of children with mild or moderate atopic dermatitis. All children will receive the standard of care. Half of the children will receive topical L. reuteri in emollient, while the other half will receive the standard of care plus control product

Start: February 2020

BioDay Registry: Data Collection Regarding the Use of New Systemic Treatment Options in Patients With Atopic Dermatitis

The BioDay Registry aims to address the need for daily practice data regarding the effectiveness and safety of new systemic treatment options in patients with AD and effect on other atopic comorbidities in a multicenter setting. The registry already consists of several additional modules concerning atopic comorbidities, like food allergy and asthma, and a module for conjunctivitis during dupilumab treatment.

Start: January 2018

The Factors Affecting Atopic Dermatitis in Children Age 1-3

This study evaluates the influence of different triggers on atopic dermatitis manifestation in children under 3 years old.

Start: March 2020

Identifying Atopic Dermatitis Patients at Risk for Developing Conjunctivitis During Dupilumab Treatment

Study on ophthalmological comorbidities and the underlying pathomechanisms of conjunctivitis during dupilumab treatment in atopic dermatitis (AD) patients. Patients participate in the Bioday Registry.

Start: February 2020

Inflammatory Cells From Various Pathologies

The objective of this experiment is to develop and validate in vitro methods to isolate inflammatory cells from skin biopsies for quantitative flow cytometry analysis. Real-time polymerase chain reaction (RT-PCR) will also be performed using skin biopsy samples to validate flow cytometry results. Such methods could eventually be used to better understand the pathophysiology and the mechanism of action of various medications in patients with atopic dermatitis, acne rosacea or vulgaris, HS, and systemic sclerosis. In this study, up to 15 healthy volunteers, 50 patients with atopic dermatitis, 15 patients with acne rosacea, 15 patients with psoriasis (to be used as control), 15 patients with acne vulgaris, 10 patients with psoriasis to develop a method of analysis for systemic sclerosis, and 10 patients with HS will be recruited. For the healthy volunteers, atopic dermatitis, psoriasis and HS groups, at least one (1) and a maximum of four (4) skin biopsies (4-5 mm) per subject will be performed. Biopsies will be performed on either the trunk or the limbs, excluding the hands and the feet. At least one (1) and a maximum of three (3) skin biopsies (2-3 mm) per subject will be collected for the acne rosacea and acne vulgaris groups from one or more body location(s) affected by the pathology. For patients with atopic dermatitis, an optional blood draw of up to 10 mL will be collected to measure serum IgE levels. For patients with atopic dermatitis, psoriasis, and HS, an optional blood collection of up to 50 mL will be collected to perform flow cytometry on circulating blood cells to study differences in flow cytometry results between cells extracted from biopsies and circulating cells.

Start: May 2014

The Role of Bacterial Toxins in Human Skin Disease

Atopic dermatitis and psoriasis are two skin diseases often associated with bacterial infections and inflammation. Studies indicate that skin cells from these patients may have some changes that make these patients more susceptible to bacterial infections. Inflammatory environment may have an effect on the function of skin cells. The purpose of this study is to learn more about skin cells (keratinocytes and fibroblasts) and how they regulate skin barrier function. To study this we need to establish skin cells that can be grown in the laboratory. We will use small skin biopsies from patients with atopic dermatitis, psoriasis and healthy people as a source of these cells. Since these skin cells have a limited lifetime when grown in laboratory as part of the project we would like to modify them, which allows them to grow for long time in the research laboratory. Some of the collected skin biopsies and isolated skin cells will be used to examine what gene products they make.

Start: September 2016

The Epidemiology, Management, and the Associated Burden of Mental Health, Atopic and Autoimmune Conditions in Alopecia Areata

This study series consists of three related studies and aims to explore and describe many important elements of Alopecia areata over three key areas: (i) the current epidemiology of Alopecia areata, (ii) the prevalence and incidence of psychiatric co-morbidities in people with Alopecia areata and (iii) the prevalence and incidence of autoimmune and atopic conditions in people with Alopecia areata.

Start: March 2020