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
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.
Study Type
Interventional
Primary Outcome
Number of days of hospitalization
Secondary Outcome
Percent of body surface affected (BSA)
Condition
Toxic Epidermal Necrolysis
Intervention
Isotretinoin
Study Arms / Comparison Groups
Isotretinoin
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
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
November 2016
Completion Date
June 2020
Primary Completion Date
June 2020
Eligibility Criteria
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.
Gender
All
Ages
18 Years - 69 Years
Accepts Healthy Volunteers
No
Contacts
Arturo Saavedra, MD, PhD, 617-726-5066, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02795143
Organization ID
2016P000845
Responsible Party
Principal Investigator
Study Sponsor
Massachusetts General Hospital
Study Sponsor
Arturo Saavedra, MD, PhD, Principal Investigator, Massachusetts General Hospital
Verification Date
December 2016