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Dermatitis clinical trials

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NCT ID: NCT03057860 Recruiting - Clinical trials for Moderate-to-severe Atopic Dermatitis

TREATgermany: German National Clinical Registry for Patients With Moderate-to-severe Atopic Dermatitis

TREATgermany
Start date: February 1, 2016
Phase:
Study type: Observational [Patient Registry]

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

NCT ID: NCT03055195 Terminated - Dermatitis, Atopic Clinical Trials

Efficacy and Safety Study of Mepolizumab in Subjects With Moderate to Severe Atopic Dermatitis

Start date: March 21, 2017
Phase: Phase 2
Study type: Interventional

Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils; thereby reducing the production and survival of eosinophils which may be therapeutic in subjects with atopic dermatitis (AD). This study will investigate the efficacy and safety of mepolizumab (100 milligram [mg] subcutaneous [SC] administered every 4 weeks) compared with placebo in adult subjects with moderate to severe atopic dermatitis (AD). Subjects will be randomized 1:1 to either placebo SC or mepolizumab SC. The study will comprise of a pre-screening period of up to approximately 4 weeks, a screening period of up to 2 weeks, followed by a 16-Week study treatment period (16 weeks with the last dose of study treatment at Week 12) and follow-up period of up to 4-week. The total duration of subject participation will be approximately 26 weeks. (Note: For subjects, who may need to stop treatment with a biologic, the total Pre-Screening and Screening period may last up to 20 weeks and total duration of participation in the study may be up to 40 weeks).

NCT ID: NCT03054428 Completed - Dermatitis, Atopic Clinical Trials

Efficacy and Safety of Dupilumab in Participants ≥12 to <18 Years of Age, With Moderate-to-severe Atopic Dermatitis

Start date: March 21, 2017
Phase: Phase 3
Study type: Interventional

The primary objective of the study was to demonstrate the efficacy of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe atopic dermatitis (AD). The secondary objective of the study was to assess the safety of dupilumab as a monotherapy in participants ≥12 years to <18 years of age with moderate-to-severe AD.

NCT ID: NCT03052348 Not yet recruiting - Clinical trials for Severe Atopic Dermatitis

Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Active Comparator in Atopic Dermatitis.

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

Atopic dermatitis (AD) is a chronic, relapsing inflammatory skin disease that occurs most commonly during early infancy and childhood. It is frequently associated with abnormalities in skin barrier function, allergen sensitization and recurrent skin infections. AD is a major public health problem worldwide, with prevalence in children of 10-20% and 2-5% of the general population. The skin of AD patients is susceptible to colonization and infection with Staphylococcus aureus (SA )which contribute significantly to the severity of the clinical manifestations of eczema, triggering a vicious cycle. Fusidic Acid (FA) cream is a topical antibiotic widely used in the treatment of skin and soft tissue infections and infected atopic dermatitis. However in recent years, the emergence of drug-resistant organisms, e.g. Methicillin- resistant Staphylococcus aureus (MRSA) has led to scrutiny of antibiotic use. Prolonged use of topical FA has been linked with emergence of FA-resistant Staphylococcus aureus (FRSA) . Fusidic acid is a natural antibiotic, extracted from cultures of Fusidium coccineum, which has a powerful antibacterial action. Topical use of Fusidic acid is fully in line with therapeutic strategies that recommend the use of an antibiotic with the narrowest activity spectrum to minimize the risk of resistance. In AD with infected lesions, combined treatment with antibiotic and steroid demonstrates greater efficacy over the use of steroid. Trial Design: A three-center, double blind, randomized ,phase II , parallel group, efficacy trial. Type of Intervention: A triple compounded cream containing a topical antibiotic , topical steroid and moisturizer. Type of control: Active control containing a double compounded cream comprising a topical steroid and moisturizer . Study population and Setting: A sample of 78 subjects will be recruited from Red Cross Children's Hospital , Nelson Mandela Academic Hospital and King Edward Hospital Estimated duration of trial: 12 months. Duration of participation: Each subject will participate in the trial for a maximum of 140 days. Primary endpoint: reduction in SCORAD scores; frequency of clinical flares for AD and improvement in the quality of life at 140 days. The benefit of this trial is that it provides a simple and effective approach to the management of atopic eczema.

NCT ID: NCT03051958 Completed - Atopic Dermatitis Clinical Trials

Internet-based Mindfulness and Exposure Treatment for Atopic Dermatitis

Start date: March 29, 2017
Phase: N/A
Study type: Interventional

Atopic dermatitis (AD) is highly prevalent and leads to suffering for the individual, increased risk of depressive symptoms and anxiety, and high societal costs. A few psychological treatment have been tested for AD, but to our knowledge none of them have been built on recently developed methods for optimizing exposure treatment. In addition, access to psychological treatment is limited and there is a need for new methods that could be easily disseminated. One possible solution to this problem is to deliver psychological treatment via the Internet, which has been tested in more than 100 randomized trials with good results for other clinical disorders than AD. The aim of this study was to test the effects of Internet-delivered mindfulness and exposure treatment (I-MET) for AD in a randomized controlled trial. We hypothesized that I-MET would lead to larger reductions of AD symptoms as well as psychological symptoms compared to treatment as usual.

NCT ID: NCT03051347 Completed - Psoriasis Clinical Trials

Asthma and Atopic Dermatitis Validation of PROMIS Pediatric Instruments

Start date: September 2016
Phase: N/A
Study type: Interventional

This is designated to validate patient-reported outcomes (PRO) measures in itch-specific pediatric skin conditions, such as atopic dermatitis, and examine the ability of a modified stigma instrument to assess the severity and type of stigma experienced in atopic dermatitis and other potentially stigmatizing conditions.

NCT ID: NCT03051321 Recruiting - Incontinence Clinical Trials

Maintaining Lower Levels of Care Through Automated Perineal Hygiene

Start date: April 1, 2017
Phase: N/A
Study type: Interventional

The inability to independently manage perineal hygiene after toileting is a common issue for those in assisted living and nursing home environments. It is associated with skin breakdown (dermatitis), increased nursing costs, and loss of patient self-esteem and independence. Water-based toileting has been evaluated as a possible adjunct to patient care, but its uptake has been limited by ineffective cleansing and drying. 40 subjects with limitations in independent capacity for perineal hygiene that require assistance with toileting will be recruited from a continued care retirement center. Subjects will be assessed for incontinence, and skin breakdown or irritation. Subjects will be provided a Wellness Toilet System, cleanser, and, if needed, zinc oxide barrier spray to be applied in cases of dermatitis. Investigators hypothesize that subjects given the device will remain more independent, with higher quality of life. Secondary hypotheses are that subjects will experience improved relationships with their caregivers, and that active dermatitis will be treated in those already with the condition, and prevented in those at risk.

NCT ID: NCT03050658 Recruiting - Atopic Dermatitis Clinical Trials

Bathing Babies and Allergy

BBA
Start date: February 7, 2017
Phase: N/A
Study type: Observational

Atopic dermatitis (AD) is a chronic allergic skin disease with onset in early childhood and increasing prevalence in Westernized countries. Current well newborn guidelines for washing babies with soap were adopted by U.S. hospitals in the 1970s, before the rise in prevalence of allergic disease and AD (also called eczema). Increased transepidermal water-loss (TEWL) in newborn skin at 2 days of life was recently identified as a predictor of AD and allergy development by age 2 years. Risk for AD in babies was also linked to decreased skin colonization with certain skin microflora, such as staphylococcal organisms. Together, these data raise the question of whether newborn skincare guidelines have the potential to modify a baby's risk for allergy development. Our current practice of washing babies with soap may alter TEWL or other natural factors in skin that protect babies from development of AD and allergy. More knowledge is needed about the impact of infant skincare practices on allergy development. The objective of this pilot study is to determine the impact of a baby's first bath on his/her transepidermal water loss (TEWL) and skin microflora. Study procedures will include collection of TEWL measurements and skin swabs for skin microflora analysis pre/post first bath in healthy term newborns at UVA. This data will serve as preliminary data for future studies.

NCT ID: NCT03050294 Completed - Psoriasis Clinical Trials

Evaluating Treatment Resistant Dermatitis TaroIIR

Start date: February 1, 2017
Phase: Phase 4
Study type: Interventional

Psoriasis and atopic dermatitis are chronic inflammatory disease that account for a significant amount of patients in most dermatological practices. Topical corticosteroid agents are often prescribed for treatment of both these conditions, especially when they are localized rather than wide spread. The development of resistance to treatment is termed tachyphylaxis. Poor adherence, rather than down regulation of receptors, may be the primary cause of tachyphylaxis to topical corticosteroids. The primary objective of the study is to determine, under conditions designed to assure good adherence, whether topical 0.25% desoximetasone spray improves clinical outcomes in patients who have resistant inflammatory skin disease defined by failure of previous topical steroid treatment.

NCT ID: NCT03050151 Completed - Eczema, Atopic Clinical Trials

Study of Dupilumab Auto-injector Device When Used by Patients With Atopic Dermatitis

Start date: February 28, 2017
Phase: Phase 1
Study type: Interventional

To collect data on actual-use to assess technical performance and user injections of dupilumab auto-injection device by patients with atopic dermatitis (AD).