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Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis (TEN)

Primary Purpose

Toxic Epidermal Necrolysis

Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Clobetasol 0.05% ointment
Placebo
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Toxic Epidermal Necrolysis

Eligibility Criteria

7 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Davis Department of Dermatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Clobetasol 0.05% ointment

Placebo

Arm 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.

All patients will have one arm assigned to receive the placebo treatment (topical petrolatum ointment) applied daily for a period of fourteen days.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
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.

Full Information

First Posted
December 15, 2014
Last Updated
August 7, 2019
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT02319616
Brief Title
Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis
Acronym
TEN
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
November 2016 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxic Epidermal Necrolysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clobetasol 0.05% ointment
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
All patients will have one arm assigned to receive the placebo treatment (topical petrolatum ointment) applied daily for a period of fourteen days.
Intervention Type
Drug
Intervention Name(s)
Clobetasol 0.05% ointment
Intervention Description
Blinded, daily application to one arm for a period of fourteen (14) days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Blinded, daily application to one arm for a period of fourteen (14) days
Primary Outcome Measure Information:
Title
Safety (numeric cellulitis score)
Description
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.
Time Frame
14 days
Title
Time to Cessation of Skin Detachment
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time to 90% re-epithelialization
Description
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.
Time Frame
14 days
Title
Percent Affected Surface Area
Description
Percent affected surface area will be measured with daily skin examinations and compared between the placebo and steroid treated skin in patients with TEN
Time Frame
14 days
Title
Percent Affected Surface Area Detached Skin
Description
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.
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emanual Maverakis, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Davis Department of Dermatology
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26297574
Citation
Wilken R, Li CS, Sharon VR, Kim K, Patel FB, Patel F, Maverakis E. Topical clobetasol for the treatment of toxic epidermal necrolysis: study protocol for a randomized controlled trial. Trials. 2015 Aug 22;16:374. doi: 10.1186/s13063-015-0879-7.
Results Reference
derived

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Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis

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