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Dermatitis, Atopic clinical trials

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NCT ID: NCT02475447 Completed - Atopic Dermatitis Clinical Trials

Safety, Pharmacokinetics and Preliminary Efficacy of Asimadoline in Pruritus Associated With Atopic Dermatitis

Start date: July 2015
Phase: Phase 2
Study type: Interventional

Kappa-opioid receptors mediate the sensation of itch in animals and humans. Asimadoline is an orally active, selective kappa-opioid receptor agonist and has demonstrated efficacy in several preclinical pruritus models. The purpose of this Phase 2 study is to evaluate the safety, tolerability and clinical efficacy of asimadoline in patients with pruritus associated with atopic dermatitis.

NCT ID: NCT02466152 Completed - Dermatitis, Atopic Clinical Trials

Pharmacokinetic Study of Topical GSK2894512 Cream

Start date: May 28, 2015
Phase: Phase 1
Study type: Interventional

This study will assess the systemic exposure and pharmacokinetic parameters of GSK2894512 following twice daily topical administration of 1% and 2% cream in adult subjects with AD, and will provide information about the systemic safety as well as local safety and tolerability following twice daily application to up to 35% body surface area (BSA) of affected skin of subjects with AD. It will be an open-label, sequential study consisting of 2 cohorts. A cohort of 6 subjects (Cohort 1) will apply GSK2894512 (cream, 2%) to affected skin on an area ranging from 15 to 35% of the total BSA for 20 days plus a final dose on Day 21. Cohort 2 will consist of 6 subjects that will apply 1% cream. Cohort 2 will follow the same procedures as Cohort 1.

NCT ID: NCT02465606 Completed - Atopic Dermatitis Clinical Trials

A Study to Evaluate the Safety of Lebrikizumab Compared to Topical Corticosteroids in Adult Patients With Atopic Dermatitis

Start date: July 30, 2015
Phase: Phase 2
Study type: Interventional

The primary objective for this study is to evaluate the safety of lebrikizumab compared with Topical Corticosteroids (TCS) alone in patients with persistent moderate to severe Atopic Dermatitis (AD) that is inadequately controlled with TCS.

NCT ID: NCT02456480 Completed - Atopic Dermatitis Clinical Trials

Pharmacodynamics of Omiganan (CLS001) in Patients With Atopic Dermatitis

Start date: May 2015
Phase: Phase 2
Study type: Interventional

To assess the pharmacodynamics, safety/tolerability, and efficacy of omiganan in patients with mild to moderate atopic dermatitis (AD).

NCT ID: NCT02449850 Active, not recruiting - Obesity Clinical Trials

Preventing Atopic Dermatitis and ALLergies in Children

PreventADALL
Start date: December 14, 2014
Phase: N/A
Study type: Interventional

The primary objective is of the PreventADALL study is to test if primary prevention of allergic diseases is possible by simple and low cost strategies, and secondary to asses the impact of xenobiotic exposure and microbiota in and on the body and the environment on allergic disease development. The secondary objective is an exploratory focus to investigate early life risk factors for development of non-communicable diseases, including asthma and allergic diseases as well as for diseases that may share common risk factors, including cardiovascular disease, obesity and diabetes. Design: A multi-national population-based prospective birth cohort with a factorial designed randomized controlled intervention trial of two clinical interventions; skin care 0-9 months and early food introduction by 3-4 months, thereafter observation only. Recruitment in three cities (Oslo, Ostfold and Stockholm) of approximately 2500 mother-child pairs is done in two steps; first pregnant women are recruited and enrolled at the 18-weeks ultrasound investigation (n=approximately 2700) and thereafter their new-born babies are included. Randomization into four groups is done by the postal code or "township" to ensure all four intervention-groups within each "township". Visits for biological and environmental sampling, observations and investigations will be at the relevant pediatric departments (at 3-6-12-24-36 months of age) and through childhood into adulthood thereafter, provided sufficient funding.

NCT ID: NCT02426359 Completed - Clinical trials for Moderate to Severe Atopic Dermatitis

Safety and Efficacy Study of Q301 in Moderate to Severe Atopic Dermatitis Patients

Start date: April 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, double-blind, vehicle-controlled, parallel-group comparison study to evaluate the safety and efficacy of Q301 Cream vs. vehicle in adult subjects with moderate to severe AD. Study drug (Q301 Cream or vehicle) will be administered topically twice a day for 8 consecutive weeks.

NCT ID: NCT02424253 Completed - Atopic Dermatitis Clinical Trials

A Study to Determine the Efficacy of ZPL-3893787 in Subjects With Atopic Dermatitis

Start date: May 18, 2015
Phase: Phase 2
Study type: Interventional

This was a randomized, double blind, placebo controlled, parallel group study in approximately 90 subjects with moderate-severe AD Eczema Area and Severity Index (EASI) ≥12 and ≤ 48 (0-72 scale). Following a run-in subjects were randomized to receive either oral 30 mg ZPL-3893787 once daily (od) or placebo od for 8 weeks (56 days).

NCT ID: NCT02411162 Completed - Dermatitis, Atopic Clinical Trials

A Single Dose Phase I Exploratory Study in Healthy Volunteers With GSK2894512 Cream

Start date: July 7, 2015
Phase: Phase 1
Study type: Interventional

This will be an open-label, non-randomized, single-center study to assess the residency of GSK2894512 in the skin of healthy adult male volunteers with normal barrier function. The study will have two parts, Cohort 1 (Part A) followed by Cohort 2 (Part B). The study will assess the residence time in human skin . The primary objective is to evaluate the residency time in skin following topical application of two formulations of GSK2894512 Cream. The total study duration will be of 15 days including 1 to 7 days of treatment period, 8 to 14 days of post treatment period and 1 day of follow up. The screening period will be up to 28 days prior to Baseline (Day 1).

NCT ID: NCT02407756 Completed - Atopic Dermatitis Clinical Trials

A Study to Determine the Safety and Tolerability of Dupilumab (REGN668/SAR231893) in Patients Aged ≥6 to <18 Years With Atopic Dermatitis (Eczema)

Start date: March 31, 2015
Phase: Phase 2
Study type: Interventional

The primary objective of the study is to characterize the safety and pharmacokinetics (PK) of dupilumab in pediatric patients with moderate-to-severe atopic dermatitis (AD) (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age). The secondary objective of the study is to explore the immunogenicity and efficacy of dupilumab in pediatric patients with moderate-to-severe AD (for adolescents ≥12 to <18 years of age) or severe AD (for children ≥6 to <12 years of age).

NCT ID: NCT02401178 Completed - Atopic Dermatitis Clinical Trials

The Role of Filaggrin and FADS Genes on the Concentrations of PUFA Towards Its Effect on Atopic Dermatitis in Infants

FLG-FADSgen
Start date: May 2014
Phase:
Study type: Observational

The incidence of atopic dermatitis has increased dramatically in this years. Atopic dermatitis occurs due to complex interactions between genetic and environmental factors. One of the genes that consistenly linked with AD occurences is filaggrin gene (FLG gene). Mutation on the gene can induce disruption in epidermal cytoskeleton aggregation which serves to form protein-lipid, thereby disrupting the skin permeability to water and outside particles such as allergens.8-14 Several attempts have been made to prevent the occurences and progressivity of AD, one of them is LCPUFA supplementation. Until now, the clinical and meta-analysis studies have shown inconsistent results, but LCPUFA intervention in early life gives more consistent and protective results. In this study investigators would like to know about the influence of FLG gene mutation to the occurrence of atopic dermatitis, to know the composition of LCPUFA in early life in order to see protective effects of several LCPUFA, to see the influences of FADS1 and FADS2 gene polymorphism towards LCPUFA concentration from umbilical artery and buccal swab in early life and at the time AD occurs, to know about the diet at the time of AD occurrence, and to know the role of the ratio of DHA towards AA level in the development of AD due to their antagonistic effects, and to see the interactions between FLG gene, FADS gene and LCPUFA level in the development of AD.