Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study

Toxic Epidermal Necrolysis Clinical Trial

Official title: Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to determine whether isotretinoin is helpful in treating patients with an adverse cutaneous drug eruption known as toxic epidermal necrolysis (TEN).

Clinical Trial Description

Toxic epidermal necrolysis (TEN) is a potentially life-threatening skin disorder characterized by widespread redness, blistering and peeling of skin.

Currently, supportive care in the standard treatment for patients with TEN. Isotretinoin, an FDA-approved medication commonly used for treating severe acne induces differentiation of certain inflammatory cells and thus may potentially be helpful in treating patients with TEN.

This is a randomized, placebo-controlled, double-blind, pilot study comparing the efficacy and safety of isotretinoin versus placebo in treating subjects with toxic epidermal necrolysis (TEN).

Approximately 40 subjects who satisfy all inclusion and exclusion criteria will be randomly assigned in a 1:1 ratio to either isotretinoin or placebo which they will take for up to 14 days. The end of the study is defined as the time the subject is discharged from the hospital. Participants will primarily be assessed for percent body surface affected (BSA) and number of days of hospitalization. ;

Related Conditions & MeSH terms

• Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis

• NCT number: NCT02795143
• Study type: Interventional
• Source: Massachusetts General Hospital
• Status: Withdrawn
• Phase: N/A
• Start date: November 2016
• Completion date: June 2020