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

Toxic Epidermal Necrolysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02795143
• Other study ID #: 2016P000845
• Status: Withdrawn
• Phase: N/A
• Start date: November 2016
• Est. completion date: June 2020

Study information

• Verified date: December 2016
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stevens-Johnson Syndrome
• Toxic Epidermal Necrolysis

Intervention

Drug:
• Isotretinoin

Other:
• Placebo

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days of hospitalization	Number of days patient will be hospitalized.	up to 14 days
Secondary	Percent of body surface affected (BSA)	Maximum body surface affected with TEN.	up to 14 days