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

Primary Purpose

Toxic Epidermal Necrolysis

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isotretinoin
Placebo
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toxic Epidermal Necrolysis focused on measuring TEN

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 18 - 69 years of age
  2. Has biopsy-proven toxic epidermal necrolysis (TEN)

  3. If female, should not be of childbearing potential defined as:

    • Have not had menstrual periods for 12 months in a row (menopause) OR
    • Had bilateral oophorectomy or total hysterectomy OR
    • Have a ovarian disorder that would make pregnancy not possible

Exclusion Criteria:

  1. Unknown HIV status and unwilling to undergo HIV testing
  2. Women of childbearing potential
  3. Pregnancy
  4. Breastfeeding
  5. Fasting serum triglyceride levels >25% of upper limit of normal
  6. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels >2× upper limit of normal (ULN)
  7. Known allergy to isotretinoin
  8. History of suicidal attempt, psychosis, major depression or other serious mood disorders
  9. Currently taking vitamin A supplements, tetracyclines, phenytoin, corticosteroids, IVIg or St. John's Wort
  10. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments
  11. Participation in an interventional study within the past 30 days.

Sites / Locations

  • Massachusetts General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Isotretinoin

Placebo

Arm Description

Isotretinoin will be given at the following dosage: Dosing will be as listed on the table below. Weight in Kg Total Daily Dose 40-49 Kg 40mg 50-89 Kg 80mg 90-150 Kg 120mg

Subjects will be given placebo capsules twice a day.

Outcomes

Primary Outcome Measures

Number of days of hospitalization
Number of days patient will be hospitalized.

Secondary Outcome Measures

Percent of body surface affected (BSA)
Maximum body surface affected with TEN.

Full Information

First Posted
June 6, 2016
Last Updated
June 5, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02795143
Brief Title
Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study
Official Title
Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Withdrawn
Why Stopped
PI (Responsible Party) transferred to new institution prior to enrollment and protocol was closed.
Study Start Date
November 2016 (undefined)
Primary Completion Date
June 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxic Epidermal Necrolysis
Keywords
TEN

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Isotretinoin
Arm Type
Experimental
Arm Description
Isotretinoin will be given at the following dosage: Dosing will be as listed on the table below. Weight in Kg Total Daily Dose 40-49 Kg 40mg 50-89 Kg 80mg 90-150 Kg 120mg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Subjects will be given placebo capsules twice a day.
Intervention Type
Drug
Intervention Name(s)
Isotretinoin
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of days of hospitalization
Description
Number of days patient will be hospitalized.
Time Frame
up to 14 days
Secondary Outcome Measure Information:
Title
Percent of body surface affected (BSA)
Description
Maximum body surface affected with TEN.
Time Frame
up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 - 69 years of age Has biopsy-proven toxic epidermal necrolysis (TEN) If female, should not be of childbearing potential defined as: Have not had menstrual periods for 12 months in a row (menopause) OR Had bilateral oophorectomy or total hysterectomy OR Have a ovarian disorder that would make pregnancy not possible Exclusion Criteria: Unknown HIV status and unwilling to undergo HIV testing Women of childbearing potential Pregnancy Breastfeeding Fasting serum triglyceride levels >25% of upper limit of normal Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels >2× upper limit of normal (ULN) Known allergy to isotretinoin History of suicidal attempt, psychosis, major depression or other serious mood disorders Currently taking vitamin A supplements, tetracyclines, phenytoin, corticosteroids, IVIg or St. John's Wort Has any condition that, in the opinion of the investigator, would make participation not be in the best interest (for example, compromise the well-being) of the participant or that could prevent, limit, or confound the protocol-specified assessments Participation in an interventional study within the past 30 days.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arturo Saavedra, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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