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

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ClinicalTrials.gov Identifier: NCT02795143
Recruitment Status : Unknown
Verified December 2016 by Arturo P Saavedra, Massachusetts General Hospital.
Recruitment status was:  Recruiting
First Posted : June 9, 2016
Last Update Posted : December 7, 2016
Information provided by (Responsible Party):
Arturo P Saavedra, Massachusetts General Hospital

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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

Primary Outcome Measures :
  1. Number of days of hospitalization [ Time Frame: up to 14 days ]
    Number of days patient will be hospitalized.

Secondary Outcome Measures :
  1. Percent of body surface affected (BSA) [ Time Frame: up to 14 days ]
    Maximum body surface affected with TEN.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795143

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Contact: Arturo Saavedra, MD, PhD 617-726-5066 harvardskinstudies@partners.org

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United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Arturo Saavedra, MD, MBA    617-726-5066    asaavedra@partners.org   
Principal Investigator: Arturo Saavedra, MD, MBA         
Sponsors and Collaborators
Massachusetts General Hospital
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Principal Investigator: Arturo Saavedra, MD, PhD Massachusetts General Hospital
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Responsible Party: Arturo P Saavedra, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02795143    
Other Study ID Numbers: 2016P000845
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: December 7, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Arturo P Saavedra, Massachusetts General Hospital:
Additional relevant MeSH terms:
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Stevens-Johnson Syndrome
Drug Eruptions
Skin Diseases
Mouth Diseases
Stomatognathic Diseases
Erythema Multiforme
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Dermatologic Agents