Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis

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"Treatment of toxic epidermal necrolysis/Stevens-Johnson’s Syndrome with topical steroid to characterize the genetic makeup of the disease."
Age: 7 to 85 years old
Gender:
Any
Healthy Volunteers: No
Keywords: Toxic Epidermal Necrolysis, TEN, Stevens-Johnson’s Syndrome
Type: Drug study, Phase [1, 2]
Target:
15 Participants
Investigator:
Description
We invite you or your child to take part in a research study because you or your child had a biopsy showing that you/they are suffering from toxic epidermal necrolysis/Stevens-Johnson’s Syndrome, a severe immune-mediated disease.

This research is being done to investigate the safety and efficacy of the topical steroid, clobetasol 0.05% ointment, in the experimental treatment of toxic epidermal necrolysis/Stevens-Johnson’s Syndrome with topical steroids and to characterize the genetic makeup of the disease and its response to therapy.
This study requires

Since there are diseases that look similar, an initial biopsy will be taken to determine if you or your child qualify for this study. This is routine standard of care.

The study doctor will randomly assign small areas (less than 3% of total body surface area) of affected skin to receive either clobetasol 0.05% ointment or petrolatum ointment. This randomization will be done by coin toss. The treatment you get on each designated area will be chosen by chance. Neither you nor the study doctor will choose what treatment to get on each treatment area.

The amount of clobetasol ointment that will be applied is based on your/your child’s body surface area. Following application of the ointments, the treated skin will be dressed with proper wound care gauze dressings. The treatment will be applied once daily for up to 14 days.

As a measure of safety, each treatment area will receive a numeric score. The study team will monitor for redness, swelling and other signs of cellulitis (local infection). Your treated areas of skin will be evaluated daily. If one of your treated areas appears at least 30% worse than the other, study personnel will evaluate for possible local infection. They may possibly stop application of ointment to that area if indicated. The areas of treated skin will be photographed daily in a way that does not disclose your identity. This will help the researchers track the appearance of the skin during the study.

Study personnel will assess if the study ointments are having any effect on your/your child’s skin through daily examinations. Both arms will be photographed daily before application of ointments.

On day three of therapy, two small 4 mm punch biopsies will be obtained, one from each treated area of skin.

These biopsy samples are collected by numbing up your skin with an injectable numbing medication (anesthetic). Then, by use of a circular punch tool, a small piece of skin will be removed and analyzed in the researcher’s laboratory. The wound will be stitched closed with dissolvable material that does not need to be removed. These biopsy specimens will be used for research purposes to determine the genetics of your/your child’s disease. Following the final application of ointment, a post-treatment evaluation will be conducted. For patients that complete all 14 days of treatment, this final evaluation will occur on day 15.

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 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 of participating in this study.


RISKS:

Your physician will review the risks of this study with you.
Compensation
You will not be paid to take part in this study.
Resources
Schedule
Study duration and period
You will be in the study for about 2 weeks.
Recruitment period
From Nov. 8, 2016 to Aug. 28, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Lynda Painting

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