Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis

NCT02319616 | Withdrawn Phase 1 DMC FDA Drug

• 1 other identifier: 804284
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Toxic Epidermal Necrolysis

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Time to 90% re-epithelialization

  14 days

• Percent Affected Surface Area

  14 days

• Percent Affected Surface Area Detached Skin

  14 days

Study Arms (2)

Clobetasol 0.05% ointment

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Clobetasol 0.05% ointment DRUG

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

Clobetasol 0.05% ointment

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 7 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California, Davis Department of Dermatology

Sacramento, California, 95816, United States

Location

Related Publications (1)

• 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.

  PMID: 26297574 DERIVED

MeSH Terms

Conditions

Stevens-Johnson Syndrome

Interventions

Clobetasol; Ointments

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Erythema Multiforme; Erythema; Skin Diseases, Vesiculobullous; Hypersensitivity, Delayed; Hypersensitivity; Immune System Diseases; Drug Hypersensitivity; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Emanual Maverakis, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2014
• First Posted: December 18, 2014
• Study Start: November 1, 2016
• Primary Completion: February 6, 2019
• Study Completion: February 6, 2019
• Last Updated: August 9, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)