Toxic Epidermal Necrolysis Clinical Trial
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)
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).
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
;
| 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
|