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

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Mass General Brigham

Status

Withdrawn

Conditions

Toxic Epidermal Necrolysis

Treatments

Drug: Isotretinoin
Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT02795143
2016P000845

Details and patient eligibility

About

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).

Full 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.

Sex

All

Ages

18 to 69 years old

Volunteers

No 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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

0 participants in 2 patient groups, including a placebo group

Isotretinoin
Experimental group
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
Treatment:
Drug: Isotretinoin
Placebo
Placebo Comparator group
Description:
Subjects will be given placebo capsules twice a day.
Treatment:
Other: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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