Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02319616
Recruitment Status : Withdrawn (Lack of enrollment)
First Posted : December 18, 2014
Last Update Posted : August 9, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

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).

Condition or disease Intervention/treatment Phase
Toxic Epidermal Necrolysis Drug: Clobetasol 0.05% ointment Drug: Placebo Phase 1 Phase 2

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : November 2016
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019


Arm Intervention/treatment
Experimental: Clobetasol 0.05% ointment
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.
Drug: Clobetasol 0.05% ointment
Blinded, daily application to one arm for a period of fourteen (14) days

Placebo Comparator: Placebo
All patients will have one arm assigned to receive the placebo treatment (topical petrolatum ointment) applied daily for a period of fourteen days.
Drug: Placebo
Blinded, daily application to one arm for a period of fourteen (14) days




Primary Outcome Measures :
  1. Safety (numeric cellulitis score) [ Time Frame: 14 days ]
    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.

  2. Time to Cessation of Skin Detachment [ Time Frame: 14 days ]
    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 :
  1. Time to 90% re-epithelialization [ Time Frame: 14 days ]
    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.

  2. Percent Affected Surface Area [ Time Frame: 14 days ]
    Percent affected surface area will be measured with daily skin examinations and compared between the placebo and steroid treated skin in patients with TEN

  3. Percent Affected Surface Area Detached Skin [ Time Frame: 14 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   7 Years to 85 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02319616


Locations
Layout table for location information
United States, California
University of California, Davis Department of Dermatology
Sacramento, California, United States, 95816
Sponsors and Collaborators
University of California, Davis
Investigators
Layout table for investigator information
Principal Investigator: Emanual Maverakis, MD University of California, Davis

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02319616    
Other Study ID Numbers: 804284
First Posted: December 18, 2014    Key Record Dates
Last Update Posted: August 9, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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
Additional relevant MeSH terms:
Layout table for MeSH terms
Stevens-Johnson Syndrome
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Skin Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Clobetasol
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs