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

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Treatments: Isotretinoin

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.