Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: Phase III Randomized Trial of the Treatment of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis Comparing Supportive Care, Cyclosporine, and Biologic Therapy in Adults
Brief Summary: Defining the true effect of adjunctive therapy for Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis (SJS/TEN) on time to full healing, mortality, and long-term outcomes represents a critical need in the field of dermatology and burn surgery. Collaborating with 20 sites from across North America we will determine if cyclosporine or etanercept therapy improves SJS/TEN short outcomes above supportive care alone The scientific premise for this study is that case series, cohorts, and small non-randomized studies have not supported the use of non-pulsed corticosteroids and intravenous immunoglobulin (IVIG), while showing the promise of cyclosporine and etanercept in reducing the time to complete re-epithelialization. By indirect comparison, etanercept appears to be superior in small studies, however none of the studies have evaluated these therapies in a blinded and randomized trial. Additionally, we will uncover the underlying process of SJS/TEN through the analysis of skin samples, blood, blister fluid and immune cells to study the immune system and changes in gene expression with and without drug therapy. This will improve the treatment of patients in the future.