Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02795143
Status:
WITHDRAWN
Last Update Posted:
2023-06-07
First Post:
2016-06-06
Brief Title:
Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions ACDEs A Pilot Study
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions ACDEs A Pilot Study
Status:
WITHDRAWN
Status Verified Date:
2016-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI Responsible Party transferred to new institution prior to enrollment and protocol was closed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None