Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis (NCT02319616) | Clinical Trial Compass
WithdrawnPhase 1/2
Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis
Stopped: Lack of enrollment
United States0Started 2016-11
Plain-language summary
The primary objectives of this study are to investigate the efficacy and safety of topical steroid ointment (clobetasol 0.05%) for the treatment of the cutaneous manifestations of toxic epidermal necrolysis (TEN).
Who can participate
Age range7 Years – 85 Years
SexALL
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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.