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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02795143

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Toxic Epidermal Necrolysis	Drug: Isotretinoin Other: Placebo	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Nov 1, 2016

Anticipated Primary Completion Date :

Jun 1, 2020

Anticipated Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Isotretinoin 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
Placebo Comparator: Placebo Subjects will be given placebo capsules twice a day.	Other: Placebo

Arm

Intervention/Treatment

Experimental: Isotretinoin

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

Placebo Comparator: Placebo

Subjects will be given placebo capsules twice a day.

Other: Placebo

Outcome Measures

Primary Outcome Measures

Number of days of hospitalization [up to 14 days]
Number of days patient will be hospitalized.

Secondary Outcome Measures

Percent of body surface affected (BSA) [up to 14 days]
Maximum body surface affected with TEN.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 69 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02114

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator: Arturo Saavedra, MD, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arturo P Saavedra, Principal Investigator, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT02795143

Other Study ID Numbers:

2016P000845

First Posted:

Jun 9, 2016

Last Update Posted:

Dec 7, 2016

Last Verified:

Dec 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Arturo P Saavedra, Principal Investigator, Massachusetts General Hospital

TEN

Additional relevant MeSH terms:

Stevens-Johnson Syndrome

Drug Eruptions

Isotretinoin

Study Results

No Results Posted as of Dec 7, 2016