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Dermatitis clinical trials

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NCT ID: NCT03901144 Completed - Dermatitis, Atopic Clinical Trials

A NOVel Moisturiser for Atopic Dermatitis: Effect on the Skin Barrier

Start date: February 21, 2019
Phase: Phase 2
Study type: Interventional

Atopic dermatitis (AD) is among the most common chronic types of inflammatory skin disease and it is characterised by exacerbations or relapses over years. The patients have a genetically impaired skin barrier that can be evaluated by measuring the transepidermal water loss (TEWL), which is increased in both dry skin and clinically normal skin in AD patients. Moisturisers are first line treatment for AD patients and moisturisers are the most prescribed products in dermatology. The use of moisturisers have been found to reduce the need for steroids. The newly developed moisturizing cream 1107.57 is intended for people with dry skin symptoms, such as dryness, itching, and flaking. As most people with dry skin of different origin have an impaired skin barrier function, it is important to investigate the possible influence on the skin barrier after long-term (several weeks') treatment. It is of utmost importance to evaluate different moisturisers head-to-head in order to facilitate an evidence-based choice of moisturiser. The primary objective of the trial is to determine whether applying the test cream 1107.57 for 4 weeks is superior in terms of skin barrier strengthening, when compared with (1) no treatment and (2) two reference creams in adults with a predisposition to a skin barrier defect. Secondary objectives are to determine whether there is a difference between 1107.57 and (1) no treatment and (2) the two reference creams in skin moisturization, tolerability, cream consumption and safety. Participants will treat their lower volar forearms for 28 days with three different creams (test cream and two reference creams) and leave one area untreated as a control. Each forearm will have two different treatment areas and treatment allocation will be randomized. One Finger Tip Unit (FTU) of each cream will be applied twice daily on the designated study area for 28 days. On day 1 and 29 the transepidermal water loss (TEWL) and skin capacitance is measured on their forearms to evaluate the effect on skin barrier function and skin hydration. Furthermore, on day 31, after challenge with 1 % sodium lauryl sulphate (SLS) on day 29, the susceptibility to irritation caused by SLS will be evaluated visually and by measuring TEWL on their forearms. Study participants will attend visits at the start of randomised therapy and on day 5, 15, 29 and 31. During the study period the participants will also grade and evaluate the tolerability of the different creams.

NCT ID: NCT03898427 Completed - Atopic Dermatitis Clinical Trials

Scratch Behavior Under Standard of Care

SOC
Start date: April 4, 2019
Phase:
Study type: Observational

Wrist-worn accelerometers and associated data analysis platforms will provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic Atopic Dermatitis (AD) population. The overall research aim is to evaluate the sensitivity of digital devices to capture drug-induced (standard of care treatments; SOC) quantitative changes in nighttime scratch and sleep quantity in AD subjects. In the current study, the investigators aim to evaluate the ability of wrist-worn accelerometers to detect significant and clinically meaningful changes in scratch behavior and sleep quantity in patients with symptomatic AD aged 2 to 75 years, receiving topical SOC treatment for AD. To evaluate this experimental paradigm, using wearable accelerometers, traditional patient-reported outcome measures/observer-reported outcome (ObsRO) (PRO/ObsRO), thermal videography and physician assessments of AD will be assessed in a well-controlled observational methodology study that has both an in-patient and out-patient portions within the study.

NCT ID: NCT03883828 Completed - Clinical trials for Radiation Dermatitis

Bacterial Decolonization to Prevent Radiation Dermatitis

Start date: June 3, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether bacterial decolonization of the nares and skin prior to treatment with radiotherapy (RT) for patients with cancers of the head and neck or breast, can prevent high-grade radiation dermatitis (RD) and improve quality of life. This study is being conducted because prior studies from this research group have found bacterial colonization in the nose prior to initiation of RT to be associated with an increased risk of high-grade RD. Patients in the treatment arm will receive pretreatment with mupirocin ointment to the nares and chlorhexidine wash to the body while patients in the control arm will receive standard of care treatment. Bacterial cultures will be taken from the nares and skin, and participants will also complete a quality of life questionnaire before and after RT.

NCT ID: NCT03874039 Completed - Atopic Dermatitis Clinical Trials

Sweat and Gas Sensor for Healthy Skin and Atopic Dermatitis

Start date: January 15, 2019
Phase:
Study type: Observational

Pilot study of a wearable gas and sweat skin sensor

NCT ID: NCT03873220 Completed - Atopic Dermatitis Clinical Trials

Monitoring Of Scratch Via Accelerometry In Children

MOSAIC
Start date: December 14, 2018
Phase:
Study type: Observational

Sleep sensors, wrist worn accelerometers, polysomnography (PSG), and associated data analysis platforms would provide quantitative and qualitative knowledge regarding the action of scratching and sleep quantity in a symptomatic atopic dermatitis (AD) population. The overall aim of this research is to validate the use of sensor technology and digital measures to quantitatively and qualitatively evaluate scratch and sleep in AD patients, and specifically in this study in children ages 2 to 11 years. To evaluate this experimental paradigm, the investigators propose using wearable accelerometers, a sleep sensor, PSG, videography and associated traditional patient-reported outcome measures/clinical outcome assessments (PRO/COA) in patients/caregivers with AD in a well-controlled in-laboratory and at-home study.

NCT ID: NCT03871998 Completed - Food Allergy Clinical Trials

Short-term Topical Application to Prevent Atopic Dermatitis

STOP AD
Start date: April 16, 2019
Phase: N/A
Study type: Interventional

This is a randomised, open-label, controlled study designed to investigate the effect of short-term neonatal skin barrier protection using a commercially available moisturiser on the prevention of atopic dermatitis and food allergy in high risk children.

NCT ID: NCT03868098 Completed - Dermatitis, Atopic Clinical Trials

Different Application Rates of Crisaborole Ointment 2% in Adults With Mild to Moderate Atopic Dermatitis

Start date: May 21, 2019
Phase: Phase 4
Study type: Interventional

This study is being conducted to evaluate the efficacy and safety of 3 different application rates of topically applied Crisaborole ointment 2% over vehicle in adults with mild to moderate atopic dermatitis (AD). In each subject four application areas will be identified. Each subject will receive 4 treatments: the 3 different application rates of the active treatment and the vehicle. The areas will be randomly assigned to treatment with topical Crisaborole ointment 2% and vehicle, once daily, for 2 weeks, without occlusion.

NCT ID: NCT03831646 Completed - Psoriasis Clinical Trials

Clinical, Psychological and Genetic Characteristics in Dermatological Patients

Start date: January 20, 2019
Phase:
Study type: Observational

Atopic dermatitis (AD) and psoriasis (PS) are chronic, relapsing dermatological disorders with a high rate of psychiatric co-morbid pathology represented with depression. Brain Derived Neurotrophic Factor (BDNF) belongs to the neurotrophin family and widely studied in pathophysiology of psychiatric and dermatological disorders. A biological stress response system by altered hypothalamic-pituitary-adrenal (HPA) axis as well hypothalamic-pituitary-gonadal (HPG) axis may contribute to dermatoses and psychiatric disorders development. Various factors including gender, genetic, psychological stress, socioeconomic factors also affect the course of dermatoses. A 10-week, case-control study evaluate clinical, psychological and biochemical parameters in AD and PS patients, and healthy control volunteers (HC) depending on gender and BDNF rs6265 gene polymorphism. All parameters are evaluated twice: at disease exacerbation (study baseline) and week 10. The following methods are conducted: assessment of dermatological status, using Scoring of Atopic Dermatitis (SCORAD) and Psoriasis Area and Severity Index (PASI); assessment of depression and anxiety according to DSM-V criteria and with Hamilton Depression Rating Scale (HAM-D) and with Hamilton Anxiety Rating Scale (HAM-A); analysis of serum BDNF (ng/ml), cortisol (nmol/L), testosterone (ng/dL) and IgE levels (IU/ml, AD only); DNA extraction and genotyping of BDNF variants.The study will last during 4-5 months.

NCT ID: NCT03826901 Completed - Atopic Dermatitis Clinical Trials

Delgocitinib Cream for the Treatment of Moderate to Severe Atopic Dermatitis During 8 Weeks in Adults, Adolescents, and Children

Start date: February 20, 2019
Phase: Phase 1
Study type: Interventional

This is a multi-center, open-label trial to evaluate safety and pharmacokinetics of topical delgocitinib cream applied to pediatric subjects (2-17 years) and adult subjects (18 years and above) with atopic dermatitis.

NCT ID: NCT03824886 Completed - Pressure Ulcer Clinical Trials

Enhancing SKIN Health and Safety in Aged CARE

SKINCARE
Start date: October 1, 2018
Phase: N/A
Study type: Interventional

Aged long-term care receivers are affected by various adverse skin conditions like pressure ulcers, incontinence-associated dermatitis, dryness, intertrigo and many more. Prevention of these skin problems and the provision of general hygiene and skin care activities are key areas of nursing practice. Numerous condition specific guidelines are available and are implemented separately. The more guidelines exist, the more difficult it is for nurses to implement them all. On the other hand, there is a huge overlap in terms of aetiology, pathogenesis and prevention of aforementioned skin conditions. The overall aim of this trial is to test the feasibility and to estimate possible effects of a comprehensive skin care package targeting main nursing relevant skin problems at the same time. Therefore a study will be performed in nursing homes of the state of Berlin comparing the skin care package to standard care. Residents' safety and subjective wellbeing will increase combined with improvements in professional competence of nurses. An advisory board consisting of international experts agreed already to supervise the trial.