Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis

• Status: Withdrawn
• Trial end date: 2019-02-06
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Davis
• Treatments: Clobetasol

Criteria

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.