A Study of Experimental Treatment With Clobetasol for Stevens-Johnson’s Syndrome

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"Topical ointment for the treatment of Stevens-Johnson’s Syndrome"
Age: 7 to 85 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Stevens Johnson's Syndrome
Type: Drug study, Phase 1/2
Target:
15 Participants
Investigator:
Description
This study will investigate the efficacy and safety of topical steroid ointment (clobetasol 0.05%). It will be used for the treatment of the cutaneous manifestations of toxic epidermal necrolysis (TEN).
This study requires

Since there are diseases with similar presentations, TEN/SJS is usually diagnosed with the aid of a skin biopsy. Thus, an initial biopsy will be needed to determine if you or your child meet the inclusion criteria for this study but this is a routine standard of care.

Your physician will discuss in detail with you the treatments, visits and medical procedures you will receive. The treatment course is expected to last two weeks.

Who can participate

Inclusion criteria:

  • Characteristic histological findings on diagnostic biopsy
  • Clinical diagnosis verified by two independent physicians
  • Greater than 10% affected body surface area (BSA)
  • Ability to start treatment within seven days or less from the onset of erosions
  • Actively worsening disease (enlarging area of involvement or new erosions occurring over the last 24 hours)
  • Patient Body Surface Area (BSA) > 1.0 m2
  • Reproductive age female patients must have a negative pregnancy test prior to enrollment

Exclusion criteria:

  • Patients will be excluded if they are < 7 or > 85 years of age.
  • Patients who have documented:
  • Uncontrolled infection (e.g. documented bacteremia)
  • Malignancy
  • Known prior immunodeficiency
  • Pregnancy
  • Concurrent use of systemic corticosteroids in the burn center greater than or equal to 0.5 mg/kg/day of prednisone or equivalent dose of similar medication.
  • Greater than 70% eroded skin
  • SCORETEN score >3 on hospital admission
  • Patients will also be excluded if they have: active hepatitis and/or an ALT or AST greater than four times the normal limits, or renal insufficiency with an estimated GFR<50 mL/min/1.73m2.
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
You will not be paid to take part in this research study.
Resources
Schedule
Study duration and period
We expect that you or your child will be in this research study for approximately two weeks.
Recruitment period
From Dec. 4, 2014 to Aug. 23, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Clinical Trials Office
Research Topic
Conditions:
  • Toxic Epidermal Necrolysis

Have any questions or want to learn more? Leave your contact details below and the research team will reach out to you.


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