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Responses of Immune and Non-Immune Cells to Glucocorticoids

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Genomic Responses of Human Immune and Non-Immune Cells to Glucocorticoids

Background: The immune system defends the body against bacteria and other harmful invaders. But it can overact and attack healthy cells by mistake. The group of drugs called glucocorticoids (GCs) can calm down an overactive immune system. But they often cause negative side effects. Researchers want to learn how human genes respond to GCs. Genes live inside each cell of the body. They tell our cells how to function. Researchers hope the results of this study will show them how to develop better drugs that will have the benefits of GCs without the side effects. Objectives: To study how human genes respond to glucocorticoid drugs. Eligibility: Healthy adult volunteers ages 18 64. Design: Participants will be screened with a medical history and physical exam. They will have a heart test and blood tests. The study visit will last about 6 hours. Participants will have medical history, physical exam, and 3 blood draws. Participants will have a skin biopsy. An injection will numb the skin on one arm. Then a tool will remove a piece of skin about as big as a pencil eraser. A GC cream will be applied to the other arm. Participants will get the GC study drug for 30 minutes. It will be a liquid that will drip through a needle placed in an arm vein. Participants will have a skin biopsy of the arm that had the cream applied. Participants will have follow-up calls 1 and 4 days later. They will be asked about reactions or other health problems.

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Pharmaceutical medication involved common.study.methods.has-drugs-yes
Patients and healthy individuals accepted common.study.methods.is-healthy-no

Drug - Methylprednisolone sodium succinate(Solu-Medrol)

Methylprednisolone sodium succinate for injection, USP (SOLU-MEDROL sterile powder, Pfizer, Inc.) is an anti-inflammatory glucocorticoid which occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. 125-milligram Act-O-Vial (AOV) System: Each 2 mL AOV (when mixed) contains methylprednisolone sodium succinate equivalent to 125 milligrams methylprednisolone; also 1. ...read more on ClinicalTrials.org

Drug - Topical methylprednisolone (Advantan emulsion 0 /1%)

1 g Advantan emulsion 0.1% (Bayer) contains methylprednisolone aceponate (21-acetoxy-11beta-hydroxy-6alpha-methyl-17-propionyloxy-1,4-pregnadiene-3,20-dione) 1 mg, as the active ingredient. It is an oil-in-water emulsion containing medium chain triglycerides, caprylic-capric-stearic triglyceride, polyoxyethylene alcohol 2-stearylether, polyoxyethylene alcohol-21-stearylether, benzyl alcohol, disodium edetate, glycerol, and purified water.

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Genomic Responses of Human Immune and Non-Immune Cells to Glucocorticoids

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NCT02798523

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penl5b