View clinical trials related to Dermatitis, Atopic.
Filter by:The purpose of phase I clinical trial is to evaluate safety and efficacy in subjects with over Moderately subacute and chronic Atopic Dermatitis after inject. Also, The purpose of phase IIa clinical trial is to determine clinically proper dose capacity of FURESTEM-AD Inj. by evaluating safety and efficacy based on SCORAD INDEX in subjects with over Moderately subacute and chronic Atopic Dermatitis.
this study has been request by french health authorities to evaluate the use of flixovate in infants and its place in the treatment pathway. this study has 2 main pbjectives: 1/ Evaluation of changes in the prescription share of Flixovate® compared to other topical corticosteroids (low, medium and high potency) in the population of infants aged from 3 to 12 months, from 1st January 2010 to 31st December 2012. 2/Description of the conditions of use of Flixovate® in infants aged less than 12 months (infant profile, dosage form, dosage, treatment duration, prior, concomitant and subsequent treatments etc.).
This is an open-label, randomized, comparative study, including 4 phases: SCREENING, ACUTE, MAINTENANCE and FOLLOW-UP. Subjects will complete the SCREENING phase to check the eligibility within 7 days after they sign the written informed consent form. All eligible subjects will be enrolled in ACUTE phase to receive twice daily Fluticasone propionate (FP) 0.05% cream up to 4 weeks. The efficacy and safety in ACUTE phase will be assessed every 2 weeks up to 4 weeks or until Treatment Success which depends on which time point comes first. Then subject can get into the MAINTENANCE phase receiving either emollient twice daily plus FP 0.05% cream once daily twice a week (Group A), or emollient twice daily (Group B), by 1:1 randomization. The treatment duration in MAINTENANCE phase will be up to 20 weeks. The efficacy and safety in MAINTENANCE phase will be assessed every 4 weeks up to 20 weeks or until AD relapse that depends on which time point comes first. If subjects don't experience relapse during MAINTENANCE phase, subsequent FOLLOW-UP phase applying emollient twice daily won't be longer than another 12 weeks. Total study duration is up to 37 weeks. All subjects receive FP 0.05% cream twice daily up to 4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After randomization in MAINTENANCE phase, subjects either receive emollient twice daily extendedly plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites (Group A), or emollient twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase, all subjects apply emollient twice daily up to 12 weeks. This study will enrol 120 subjects, and propose at least 80 subjects to be randomized. Study Endpoints/Assessments: Primary endpoint is to observe the median time to the first relapse of AD during MAINTENANCE phase. Secondary endpoints are: 1. Median time to the first relapse of AD during the whole study (including maintenance phase and follow-up phase. 2. Numbers of recurrent patients at the end of MAINTENANCE phase; 3. Numbers of recurrent patients at the end of FOLLOW-UP phase; 4. The effective rates (proportion of "treatment success" patients) during ACUTE phase (V3, W-2±2days;V4, W0±2days ) 5. Evaluate the safety during the whole study duration (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively); 6. Evaluate visual skin assessment for signs of cutaneous atrophy, epidermal thickening / lichenification and abnormal pigmentation changes during the whole study duration (ACUTE phase, MAINTENANCE phase, FOLLOW-UP phase respectively); 7. The change of Quality of Life (QoL) from baseline at the end of MAINTENANCE phase; 8. The change of Quality of Life (QoL) from baseline at the end of FOLLOW-UP phase; 9. Subjects' post-study evaluation to drugs.
To demonstrate the ability of Aurstat to reduce pruritus in subjects with mild to moderate atopic dermatitis. Efficacy results will be based on subject assessment, IGA, and photographic evidence based on ordinal scales for tolerability.
Patients with atopic dermatitis treated with conventional treatment plus Dialyzed Leukocyte Extracts (DLE-oral Transferon) as adjuvant, have better clinical outcome than patients treated only with conventional treatment.
Our central hypothesis is that dietary limitations introduced by food allergy will contribute to increased food insecurity in households with food allergic children when compared to food insecure households without food allergic children.
The Polish Mother and Child Cohort is multicentre prospective study on different exposures. Prospective cohort study design enables identification of exposures that may influence pregnancy outcome and chil-dren's health, verification of such exposures by biomarker measurements and notification of any changes in exposure levels. The aim of the study is to evaluate the impact of exposure to different environmental factors during pregnancy and after birth on pregnancy outcome and children's health. Specific research hypotheses refer to the role of heavy metals, exposure to polycyclic aromatic hydrocar-bons (PAHs) and environmental tobacco smoke (ETS) in the aetiology of intrauterine growth retardation (IUGR), preterm delivery (PD) and the risk of respiratory diseases, allergy and poor mental and physical development. It is also intended to explain the role of oxidative stress and nutritional status of the pregnant women. The impact of occupational exposures and stressful situations on pregnancy outcome will be evaluated from question-naire data. The results of the study will help to determine levels of child prenatal and postnatal exposure in several areas of Poland and their im-pact on course and outcome of pregnancy and children's health. This protocol concerns the children that are followed-up from birth to the age of 2 years to determine long term effects of pre- and postnatal environmental exposures.
To assess the efficacy of multiple dupilumab (REGN668/SAR231893) dose-regimens, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).
The purpose of this study is to evaluate the effect of topical roflumilast on the reduction of atopic dermatitis lesions in adults with atopic dermatitis.
The purpose of the study is to investigate the effectiveness and cost-effectiveness of the integrated care program of a statutory health insurance offering additional homeopathic treatment to their members