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

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Brief Title

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

Official Title

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

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).
    

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 Type

Interventional


Primary Outcome

Number of days of hospitalization

Secondary Outcome

 Percent of body surface affected (BSA)

Condition

Toxic Epidermal Necrolysis

Intervention

Isotretinoin

Study Arms / Comparison Groups

 Isotretinoin
Description:  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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

November 2016

Completion Date

June 2020

Primary Completion Date

June 2020

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 69 Years

Accepts Healthy Volunteers

No

Contacts

Arturo Saavedra, MD, PhD, 617-726-5066, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02795143

Organization ID

2016P000845


Responsible Party

Principal Investigator

Study Sponsor

Massachusetts General Hospital


Study Sponsor

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


Verification Date

December 2016