Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis

NCT ID: NCT02319616

Last Updated: 2019-08-09

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1/PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2019-02-06

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

Conditions

Toxic Epidermal Necrolysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Clobetasol 0.05% ointment

Intervention Type: DRUG

Blinded, daily application to one arm for a period of fourteen (14) days

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Blinded, daily application to one arm for a period of fourteen (14) days

Interventions

Clobetasol 0.05% ointment

Blinded, daily application to one arm for a period of fourteen (14) days

Intervention Type: DRUG

Placebo

Blinded, daily application to one arm for a period of fourteen (14) days

Intervention Type: DRUG

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Emanual Maverakis, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis Department of Dermatology

Sacramento, California, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 26297574 (View on PubMed)

Other Identifiers

804284

Identifier Type: -

Identifier Source: org_study_id