Clinical trial NCT02795143: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Toxic Epidermal Necrolysis
Keywords: TEN
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2016-06-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Number of days of hospitalization
timeFrame: up to 14 days
Secondary outcomes:
measure: Percent of body surface affected (BSA)
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Arturo Saavedra, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: