Study Stopped
PI (Responsible Party) transferred to new institution prior to enrollment and protocol was closed.
Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study
1 other identifier
interventional
N/A
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 6, 2016
CompletedFirst Posted
Study publicly available on registry
June 9, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 7, 2023
December 1, 2016
3.6 years
June 6, 2016
June 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of days of hospitalization
Number of days patient will be hospitalized.
up to 14 days
Secondary Outcomes (1)
Percent of body surface affected (BSA)
up to 14 days
Study Arms (2)
Isotretinoin
EXPERIMENTALIsotretinoin 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
Placebo
PLACEBO COMPARATORSubjects will be given placebo capsules twice a day.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 \>2Ă— 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Arturo Saavedra, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 6, 2016
First Posted
June 9, 2016
Study Start
November 1, 2016
Primary Completion
June 1, 2020
Study Completion
June 1, 2020
Last Updated
June 7, 2023
Record last verified: 2016-12
Data Sharing
- IPD Sharing
- Will not share