Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02319616
Other study ID # 804284
Secondary ID
Status Withdrawn
Phase Phase 1/Phase 2
First received
Last updated
Start date November 2016
Est. completion date February 6, 2019

Study information

Verified date August 2019
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 6, 2019
Est. primary completion date February 6, 2019
Accepts healthy volunteers No
Gender All
Age group 7 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Clobetasol 0.05% ointment
Blinded, daily application to one arm for a period of fourteen (14) days
Placebo
Blinded, daily application to one arm for a period of fourteen (14) days

Locations

Country Name City State
United States University of California, Davis Department of Dermatology Sacramento California

Sponsors (1)

Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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. 14 days
Secondary 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 14 days
Secondary 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. 14 days
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04711200 - LYell SYndrome MEsenchymal Stromal Cells Treatment Phase 1/Phase 2
Completed NCT01696500 - Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. Phase 3
Terminated NCT02037347 - Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis Phase 1/Phase 2
Withdrawn NCT02795143 - Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study N/A
Recruiting NCT06119490 - Evaluation of the Efficacy and Safety of Methylprednisolone Combined With the JAK Inhibitors in the Treatment of Toxic Epidermal Necrolysis Early Phase 1
Withdrawn NCT00372723 - Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN) Phase 2
Recruiting NCT02574988 - Severe Cutaneous Adverse Reactions in Thailand
Not yet recruiting NCT03585946 - Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis