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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Toxic Epidermal Necrolysis

Intervention / Treatment
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* Drug: Isotretinoin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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: 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: 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 Currently taking vitamin A supplements, tetracyclines, phenytoin, corticosteroids, IVIg or St. John's Wort 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 Participation in an interventional study within the past 30 days.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Isotretinoin<br>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 | Drug: Isotretinoin<br> <br> |
| Placebo Comparator: Placebo<br>Subjects will be given placebo capsules twice a day. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days of hospitalization | Number of days patient will be hospitalized. | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of body surface affected (BSA) | Maximum body surface affected with TEN. | up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEN