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Dermatitis clinical trials

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NCT ID: NCT02732314 Completed - Dermatitis, Atopic Clinical Trials

Efficacy and Tolerability of New Topical Formulations in Subjects With Atopic Dermatitis

Start date: March 2016
Phase: Phase 4
Study type: Interventional

This is a 13 week randomized, double blind, parallel group, in home use study among approximately 60 male and female subjects, ages 12 to 65 years old inclusive, with atopic dermatitis (AD) SCORAD >16. Treatment group assignments will be balanced by disease severity, age, and body location of AD lesions. The study will consist of a 1 week washout phase and 12 week treatment phase. During the washout phase, subjects will be provided with a bar soap for bathing and showering and must refrain from using any other products on their body (excluding the face) including topical corticosteroids, ointments, lotions, sunscreens, etc. During the treatment phase, subjects will be randomized to 1 of 4 test legs. Throughout the treatment phase, the subjects will be required to use only the provided bar soap for bathing and showering and will apply their test product twice per day, once in the morning and once in the evening. No additional creams, moisturizers, lotions or cleansers other than those provided will be permitted for the duration of the study. Normal facial or hair care products are permitted, however, they must not contain anti-bacterial ingredients (e.g. antidandruff shampoo, acne products, etc). SCORAD, EASI and PGA will incorporate whole body assessments. However, at the Baseline visit, subjects will have an active inflammatory lesion site and adjacent non-lesion, non-inflammatory site identified and marked for all instrumental and biopsy evaluations at Baseline and subsequent visits. Instrumental evaluations, imaging, expert visual grading and self-assessments will be performed throughout the study. Tolerability will be evaluated by incidence of AE's (defined per CTCAE), exacerbation of AD lesions, application site reactions/infections, and lab evaluations throughout the study. There will be additional consumption and compliance checks as well as dermatologic evaluations to ensure the subject's condition does not become extensively worse at each visit. A subset of subjects will have 2mm punch biopsies collected from the designated lesion and non-lesion sites at 3 time points throughout the study. The subset of subjects will be determined by subject willingness to participate in the biopsy portion as well as dermatologic evaluation and determination of biopsy candidacy.

NCT ID: NCT02729324 Not yet recruiting - Clinical trials for Nasopharyngeal Neoplasms

Comparison of Efficacy and Safety Between Medical Radiation Protectants (FORRAD®) and Trolamine (Biafine) for the Management of Radiation Dermatitis in Patients With Nasopharyngeal Carcinoma Receiving IMRT

Start date: April 2016
Phase: Phase 2
Study type: Interventional

Radiation therapy remains the principal treatment for nasopharyngeal carcinoma (NPC). Although intensity modulated radiation therapy (IMRT) has been widely used in China nowadays, radiation dermatitis is still common. It has an impact on pain and quality of life, and if severe, may lead to interruption of the radiation schedule for the patient. Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. However, as long as grade ≥2 radiation dermatitis is developed, trolamine is not allowed to use any more. Medical Radiation Protectants (FORRAD®) is a new kind of topical agents for prevention and treatment of radiation dermatitis. It could be used during the course of radiotherapy, even when grade ≥2 dermatitis is developed. This randomized phase II study is aimed to assess the effectiveness and safety of Medical Radiation Protectants (FORRAD®) for the prevention and treatment of acute radiation-induced dermatitis of grade 3 or higher during IMRT for patients with NPC, compared with trolamine.

NCT ID: NCT02724449 Completed - Dermatitis Clinical Trials

A Clinical Evaluation of 3M Cavilon Advanced Barrier Film for the Treatment of Incontinence Associated Dermatitis (IAD)

Start date: August 2014
Phase: N/A
Study type: Interventional

The purpose of this study is to obtain information concerning the safety and effective use of a protective barrier film in patients experiencing severe incontinence associated dermatitis.

NCT ID: NCT02716415 Completed - Diaper Dermatitis Clinical Trials

Trial Comparing Calmoseptine Ointment and Desitin Diaper Rash Paste in Diaper Dermatitis in Neonates and Infants

Start date: March 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the efficacy and safety of Calmoseptine Ointment and Desitin Maximum Strength 40% Zinc Oxide Diaper Rash Paste in the treatment of diaper dermatitis among Neonates and Infants.

NCT ID: NCT02716181 Completed - Atopic Dermatitis Clinical Trials

Efficacy of the "Атопик Soothing Cream" in Children With Mild to Moderate Atopic Dermatitis

Start date: December 29, 2016
Phase: N/A
Study type: Interventional

A Double-Blind Randomized Placebo-Controlled Trial to Evaluate the Efficacy of the "Атопик Soothing Cream" in Children with Mild to Moderate Atopic Dermatitis

NCT ID: NCT02713035 Terminated - Dermatitis, Atopic Clinical Trials

Behavioral Self-Help Intervention for Pediatric Atopic Dermatitis and Eczema Patients

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

Patients with atopic dermatitis and eczema often struggle with habitual scratching that is not well-controlled even with optimal medical therapy. Our goal is to create a behavioral intervention to help children with eczema reduce scratching. The investigators hope that the intervention will improve clinical outcomes and quality of life, as well as provide an easily implemented way for clinicians to educate patients and parents about behavioral modification techniques.

NCT ID: NCT02700373 Completed - Contact Dermatitis Clinical Trials

A Phase I, Single-Center Study of PDC-APB in Healthy Volunteers

Start date: March 2016
Phase: Phase 1
Study type: Interventional

This is a randomized, double-blind, placebo-controlled, single ascending dose study to assess the safety and tolerability of PDC-APB by intramuscular (IM) injection compared to placebo.

NCT ID: NCT02691507 Completed - Atopic Dermatitis Clinical Trials

Trial to Determine the Therapeutic Benefit of an OTC Cream on Dry, Itchy Skin of Adults and Children With Eczema

Start date: February 2016
Phase: Phase 2
Study type: Interventional

The objective of this 1 week trial is to evaluate the efficacy of an over-the-counter (OTC) 1% colloidal oatmeal skin protectant cream in adults and children with mild to moderate AD.

NCT ID: NCT02690753 Completed - Pressure Ulcers Clinical Trials

Pressure Ulcer Prevention: a Turn and Positioning System Combined With Incontinence Care and Tailored/Standard Repositioning

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

The prevalence of pressure ulcer in hospitals is 7,3% - 23%. The primary etiological factors are pressure or pressure combined with shear. Prevention is very important and comprises: preventive skin care including cleansing and protecting the skin from exposure to moisture, the systematic repositioning of the patient, the offloading of the heels from the surface of the bed, the use of adequate bed support surfaces and an adequate nutritional status. The development and implementation of a risk based prevention plan for individuals identified as being at risk is strongly recommended. Limited compliance exists towards pressure ulcer preventive interventions. 25,5% of the patients at risk receive fully adequate prevention in bed. The reposition frequence is adequate in 55% of patients at risk. There is a lack of rigorously performed research addressing the effectiveness of devices or risk based protocols to improve compliance. Health care budgets are limited, priorities should be set in the allocation of health care resources. The primary aim of this study is to compare the effectiveness of the turn and position system (Prevalon®Turn and Position System 2.0, SAGE) versus standard care to improve reposition frequence in patients at risk. The second aim is to compare the effectiveness of a tailored protocol versus standard care to improve reposition frequence in patients at risk. The third aim is to compare the effectiveness of standardized incontinence care versus standard care to improve the incidence of pressure ulcers and incontinence-associated dermatitis (IAD). Also a health economic evaluation will be performed. The study will be performed in hospital setting (university and general hospitals) in a random sample of 226 patients aged > 18 who are at risk of developing pressure ulcers. Patients will be recruited from three types of wards: intensive care units, geriatric wards and rehabilitation wards. Patients will be included in the study for a period of 8 days.

NCT ID: NCT02683928 Completed - Atopic Dermatitis Clinical Trials

To Assess the Safety and Activity of GBR 830, Compared to Placebo, in Adults With Moderate-to-severe Atopic Dermatitis

Start date: March 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine the effect of GBR 830 on biomarkers in atopic dermatitis to enable further studies in this indication.