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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief 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).

Detailed Summary:

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.


Sponsor: Massachusetts General Hospital

Current Primary Outcome: Number of days of hospitalization [ Time Frame: up to 14 days ]

Number of days patient will be hospitalized.


Original Primary Outcome: Same as current

Current Secondary Outcome: Percent of body surface affected (BSA) [ Time Frame: up to 14 days ]

Maximum body surface affected with TEN.


Original Secondary Outcome: Same as current

Information By: Massachusetts General Hospital

Dates:
Date Received: June 6, 2016
Date Started: November 2016
Date Completion: June 2020
Last Updated: December 5, 2016
Last Verified: December 2016