WithdrawnNot Applicable

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

Stopped: PI (Responsible Party) transferred to new institution prior to enrollment and protocol was closed.

United States0Started 2016-11

Plain-language 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).

Who can participate

Age range18 Years – 69 Years

SexALL

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Inclusion criteria

✓. 18 - 69 years of age
✓. Has biopsy-proven toxic epidermal necrolysis (TEN)
✓. If female, should not be of childbearing potential defined as:

Exclusion criteria

✕. Unknown HIV status and unwilling to undergo HIV testing
✕. Women of childbearing potential
✕. Pregnancy
✕. Breastfeeding
✕. Fasting serum triglyceride levels \>25% of upper limit of normal
✕. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase levels \>2× upper limit of normal (ULN)
✕. Known allergy to isotretinoin
✕. History of suicidal attempt, psychosis, major depression or other serious mood disorders

What they're measuring

Number of days of hospitalization

Timeframe: up to 14 days

Trial details

NCT IDNCT02795143

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06

View on ClinicalTrials.gov More Toxic Epidermal Necrolysis trials