Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Toxic Epidermal Necrolysis

In brief

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).

Key facts

Study ID

NCT02319616

Run by

University of California, Davis

People needed

0

Starts

2016-11-01

Expected to finish

2019-02-06

Last updated by the study team

2019-08-09

Who can join

Age: 7 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, Davis Department of Dermatology — Sacramento, California, United States

Full record on ClinicalTrials.gov

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