Brief Title
Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis
Official 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)
Brief 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).
Detailed Description
The experimental focus of this trial is thus to evaluate the safety and clinical outcomes of topical steroid (clobetasol 0.05% ointment) for treatment of the cutaneous manifestations of toxic epidermal necrolysis (TEN). The design of the study is a randomized, placebo-controlled, double-blind split-body Phase II clinical trial in which clobetasol 0.05% or placebo ointment will be topically applied to opposite arms for a period of fourteen days. The primary endpoints of the study are to determine the time to cessation of skin detachment in both groups as well as the safety of topical clobetasol to treat the cutaneous manifestations of TEN. Secondary outcome measures will evaluate efficacy by comparing the time to re-epithelialization and the percentage of affected skin between the clobetasol and placebo arms at various time points. An additional aim of the study is to characterize the genes expressed during the TEN disease state and any changes in gene expression following treatment with topical steroids, particularly those genes involved in the regulation of programmed cell death (apoptosis). This will be accomplished though molecular analysis of skin biopsy specimens obtained after treatment with clobetasol and placebo ointments. The specific hypothesis being tested is that two weeks of topical clobetasol will promote epidermal keratinocyte survival through suppression of TNF signaling, decreased granulysin expression and inhibition of other pro-apoptotic pathways resulting in shorter disease duration and decreased time to re-epithelialization. IRB number: 642415-5
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Safety (numeric cellulitis score)
Secondary Outcome
Time to 90% re-epithelialization
Condition
Toxic Epidermal Necrolysis
Intervention
Clobetasol 0.05% ointment
Study Arms / Comparison Groups
Clobetasol 0.05% ointment
Description: All patients will have one arm assigned to receive the experimental treatment (topical clobetasol 0.05% ointment) applied daily for a period of fourteen days.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
November 2016
Completion Date
February 6, 2019
Primary Completion Date
February 6, 2019
Eligibility 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.
Gender
All
Ages
7 Years - 85 Years
Accepts Healthy Volunteers
No
Contacts
Emanual Maverakis, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02319616
Organization ID
804284
Responsible Party
Sponsor
Study Sponsor
University of California, Davis
Study Sponsor
Emanual Maverakis, MD, Principal Investigator, University of California, Davis
Verification Date
August 2019