39. 中毒性表皮壊死症 Toxic epidermal necrolysis Clinical trials / Disease details
臨床試験数 : 13 / 薬物数 : 19 - (DrugBank : 8) / 標的遺伝子数 : 11 - 標的パスウェイ数 : 103
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT02987257 (ClinicalTrials.gov) | March 15, 2023 | 25/11/2016 | NATIENS: Optimal Management and Mechanisms of SJS/TEN | NATIENS: A Phase III Randomized Double-Blinded Placebo Controlled Study to Determine the Optimal Management and Mechanisms of Stevens-Johnson Syndrome and Toxic Epidermal Necrolysis | Stevens-Johnson Syndrome;Toxic Epidermal Necrolyses | Drug: Harmonized supportive care;Drug: Cyclosporine 5 mg/kg bid days 0-14;Drug: Etanercept 50 mg sc day 0 and day 3 | Vanderbilt University Medical Center | University of Ottawa;University of Toronto | Not yet recruiting | 18 Years | N/A | All | 267 | Phase 3 | United States |
| 2 | NCT04711200 (ClinicalTrials.gov) | September 2022 | 30/11/2020 | LYell SYndrome MEsenchymal Stromal Cells Treatment | Mesenchymal Stromal Cells Treatment in Lyell Syndrome: A Pilot Phase 1-2 Open Trial | Epidermal Necrolysis;Lyell Syndrome;Toxic Epidermal Necrolysis;Overlap Syndrome;Mesenchymal Stromal Cells;Adipose Derived Stromal Cells | Drug: Adipose derived stromal cells intravenously injected | Assistance Publique - Hôpitaux de Paris | NULL | Not yet recruiting | 18 Years | 75 Years | All | 15 | Phase 1/Phase 2 | NULL |
| 3 | JPRN-jRCTs031210325 | 01/10/2021 | 17/09/2021 | Etanercept therapy for Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) cases of refractory to systemic steroid therapy | open-label, multicenter, single-arm study to evaluate the efficacy and safety of etanercept in patients with Stevens-Johnson syndrome and toxic epidermal necrolysis who were ineffective with systemic steroid therapy | stevens-johnson syndrome, toxic epidermal necrosis stevens-johnson syndrome, toxic epidermal necrosis | Etanercept 50 mg / day is subcutaneously administered on the first day (Day 1). If epithelialization is not complete, administer once on day 8 (Day 8) and day 15 (Day 15) as needed. | Abe Riichirou | NULL | Recruiting | >= 20age old | Not applicable | Both | 10 | Phase 2 | Japan |
| 4 | NCT03585946 (ClinicalTrials.gov) | January 1, 2021 | 14/3/2018 | Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis | A Prospective Multicenter Cohort Study Assessing Outcomes in Stevens Johnsons Syndrome and Toxic Epidermal Necrolysis | Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis;Drug Reaction | Drug: Site specific standard of care comparison | Massachusetts General Hospital | NULL | Not yet recruiting | 18 Years | N/A | All | 750 | NULL | |
| 5 | JPRN-jRCTs061180044 | 01/06/2017 | 12/03/2019 | Multicenter Open-trial of Steroid pulse therapy for SJS/TEN | Multicenter Open-trial of Steroid pulse therapy for SJS/TEN - MOSST Study | Stevens-Johnson syndrome and Toxic epidermal necrolysis | 1. infusion of methylprednisolone at 500~1000 mg/d (0.9% N/S in 3 hour) for 3 consecutive days. 2. Oral predonisolone (0.5 mg/kg/d) was initiated on the day following the last dose of methylprednisolone, and prednisolone was subsequently tapered within 2 weeks. If the ocular involvement score is more than 2, dose of oral predonisolone (1 mg/kg/d) is recommended. | Morita Eishin | NULL | Complete | >= 20age old | <= 90age old | Both | 20 | Phase 2 | Taiwan;Germany;Japan |
| 6 | NCT02795143 (ClinicalTrials.gov) | November 2016 | 6/6/2016 | Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study | Evaluating the Effect of Isotretinoin in Regulatory T-cell Function in Adverse Cutaneous Drug Eruptions (ACDEs): A Pilot Study | Toxic Epidermal Necrolysis | Drug: Isotretinoin;Other: Placebo | Massachusetts General Hospital | NULL | Recruiting | 18 Years | 69 Years | Both | 40 | N/A | United States |
| 7 | NCT02319616 (ClinicalTrials.gov) | November 2016 | 15/12/2014 | Topical Clobetasol for the Treatment of Toxic Epidermal Necrolysis | 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) | Toxic Epidermal Necrolysis | Drug: Clobetasol 0.05% ointment;Drug: Placebo | University of California, Davis | NULL | Withdrawn | 7 Years | 85 Years | All | 0 | Phase 1/Phase 2 | United States |
| 8 | NCT02739295 (ClinicalTrials.gov) | July 2016 | 4/4/2016 | G-CSF in the Treatment of Toxic Epidermal Necrolysis | Evaluation of G-CSF as a Treatment of Toxic Epidermal Necrolysis | Stevens - Johnson Syndrome | Drug: recombinant granulocyte - colony stimulating factor;Drug: NaCl 0.9% | University of Liege | NULL | Recruiting | 18 Years | N/A | All | 10 | Phase 4 | Belgium |
| 9 | NCT02126020 (ClinicalTrials.gov) | November 2014 | 27/4/2014 | Topical Infliximab in Autoimmune Eyes With Keratoprosthesis | Topical Infliximab in Autoimmune Eyes With Keratoprosthesis | Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis (Lyell) Syndrome;Mucous Membrane Pemphigoid | Drug: topical infliximab | James Chodosh, MD, MPH | Massachusetts Eye and Ear Infirmary;Fonds de recherche en ophtalmologie de l'Université de Montréal (FROUM) | Withdrawn | 18 Years | 80 Years | All | 0 | Phase 1/Phase 2 | United States;Canada |
| 10 | NCT01696500 (ClinicalTrials.gov) | October 2012 | 20/9/2012 | Phase III Clinical Trial of NPB-01 in Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. | NPB-01(Intravenous Immunoglobulin) Therapy for Patients With Stevens-Johnson Syndrome/ Toxic Epidermal Necrolysis Unresponsive to Corticosteroids. | Stevens-Johnson Syndrome;Toxic Epidermal Necrolysis | Drug: Intravenous immunoglobulin | Nihon Pharmaceutical Co., Ltd | NULL | Completed | 20 Years | N/A | Both | 10 | Phase 3 | Japan |
| 11 | NCT01256489 (ClinicalTrials.gov) | December 2010 | 19/11/2010 | Infliximab to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis (SJS/TENS) | Infliximab Therapy to Improve Retention of the Boston Keratoprosthesis in Patients After Stevens Johnson Syndrome/ Toxic Epidermal Necrolysis | Stevens-Johnson Syndrome;Corneal Blindness | Drug: Infliximab | Massachusetts Eye and Ear Infirmary | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 1/Phase 2 | United States |
| 12 | NCT02037347 (ClinicalTrials.gov) | October 2010 | 13/1/2014 | Study to Evaluate the Use of Palifermin to Treat Toxic Epidermal Necrolysis | Palifermin Treatment of Toxic Epidermal Necrolysis | Toxic Epidermal Necrolysis;Stevens-Johnson Syndrome | Drug: Palifermin | Brett King | Swedish Orphan Biovitrum | Terminated | 18 Years | N/A | All | 1 | Phase 1/Phase 2 | United States |
| 13 | NCT00372723 (ClinicalTrials.gov) | July 2006 | 5/9/2006 | Study of a Potential New Treatment for Patients With Toxic Epidermal Necrolysis (TEN) | Pilot Study Comparing Remicade (Infliximab) vs. Standard Care in the Treatment of Toxic Epidermal Necrolysis | Toxic Epidermal Necrolysis | Drug: Remicaide (infliximab) | Loyola University | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 2 | United States |