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

N/A

Waitlist Available

Led By Arturo Saavedra, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 14 days

Awards & highlights

All Individual Drugs Already Approved

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).

Eligible Conditions

Severe skin reaction

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of days of hospitalization

Secondary study objectives

Percent of body surface affected (BSA)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: IsotretinoinExperimental Treatment1 Intervention

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

Group II: PlaceboPlacebo Group1 Intervention

Subjects will be given placebo capsules twice a day.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Isotretinoin

FDA approved

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