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Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN)

2014-08-27 03:42:42 | BioPortfolio

Summary

To determine whether treatment of patients who have toxic epidermal necrolysis with a drug called remicaide increases the number of patients who are alive 30 days laters.

Description

This is a pilot (preliminary) study. Patients with a diagnosis of TEN will be asked to consider participating. The study intervention is a single intravenous dose of remicaide (5 mg/kg). Standard supportive care will be given. The percentage of patients alive at 30 days after treatment with remicaide will be compared to historical controls.

Study Design

Allocation: Non-Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Toxic Epidermal Necrolysis

Intervention

Remicaide (infliximab)

Location

Loyola University Medical Center
Maywood
Illinois
United States
60153

Status

Recruiting

Source

Loyola University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:42:42-0400

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Medical and Biotech [MESH] Definitions

Protein exotoxins from Staphylococcus aureus, phage type II, which cause epidermal necrolysis. They are proteins with a molecular weight of 26,000 to 32,000. They cause a condition variously called scaled skin, Lyell or Ritter syndrome, epidermal exfoliative disease, toxic epidermal necrolysis, etc.

An exfoliative disease of skin seen primarily in adults and characterized by flaccid bullae and spreading erythema so that the skin has the appearance of being scalded. It results primarily from a toxic reaction to various drugs, but occasionally occurs as a result of infection, neoplastic conditions, or other exposure.

A subgroup of PARAPSORIASIS itself divided into acute and chronic forms. The acute form is characterized by the abrupt onset of a generalized, reddish-brown, maculopapular eruption. Lesions may be vesicular, hemorrhagic, crusted, or necrotic. Histologically the disease is characterized by epidermal necrolysis. The chronic form shows milder skin changes with necrosis.

A 6-kDa polypeptide growth factor initially discovered in mouse submaxillary glands. Human epidermal growth factor was originally isolated from urine based on its ability to inhibit gastric secretion and called urogastrone. EPIDERMAL GROWTH FACTOR exerts a wide variety of biological effects including the promotion of proliferation and differentiation of mesenchymal and epithelial cells.

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