Toxic Epidermal Necrolysis Clinical Trial
— TENOfficial title:
A Randomized Placebo Controlled Split-body Double-blind Phase II Clinical Trial to Investigate the Safety and Efficacy of Clobetasol 0.05% Ointment for the Treatment of Toxic Epidermal Necrolysis (TEN)
Verified date | August 2019 |
Source | University of California, Davis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | February 6, 2019 |
Est. primary completion date | February 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 7 Years to 85 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
United States | University of California, Davis Department of Dermatology | Sacramento | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety (numeric cellulitis score) | Local infection (cellulitis) is a potential complication of treatment with topical steroid ointment. A primary outcome measure of the study will be to determine if any difference in local infection rate exists between between control and clobetasol-treated skin in patients with toxic epidermal necrolysis, determined by daily assessments and assignment of a numeric cellulitis score. | 14 days | |
Primary | Time to Cessation of Skin Detachment | The time until cessation of skin detachment (measured in days) will be determined though daily skin examinations and compared between the clobetasol and placebo-treated skin of patients with toxic epidermal necrolysis. | 14 days | |
Secondary | Time to 90% re-epithelialization | The time to 90% re-epithelialization will be determined by daily skin examinations and recorded in days to determine if a significant difference exists between control and clobetasol treated skin. | 14 days | |
Secondary | Percent Affected Surface Area | Percent affected surface area will be measured with daily skin examinations and compared between the placebo and steroid treated skin in patients with TEN | 14 days | |
Secondary | Percent Affected Surface Area Detached Skin | The percent body surface area affected by detached skin will be monitored through daily skin examinations and compared between the clobetasol and placebo treated skin in patients with toxic epidermal necrolysis. | 14 days |
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