Erythema Multiforme

Researchers are collecting clinical data and biological samples from patients with severe skin reactions caused by drugs. These conditions include Stevens-Johnson syndrome, Lyell syndrome toxic epidermal necrolysis, acute generalized exanthematous pustulosis AGEP, drug reaction with eosinophilia and systemic symptoms DRESS, drug-induced immunoglobulin A IgA bullous dermatosis, generalized bullous fixed drug reactions, maculopapular exanthema, and erythema multiforme. The goal is to better understand the biological and genetic causes of these drug reactions through research. Participants will provide various samples beyond routine care, including a small skin biopsy 6 mm punch, blood samples 43 mL, blister fluid, oral and nasal mucous membrane swabs, skin swabs, and stool samples. These samples will be stored in a specialized biological resource platform to allow detailed immunological, biological, and genetic studies. This is an observational study without specific treatment interventions. During the study, patients will undergo collection of clinical information and the biological samples described. Researchers will monitor the implementation of this collection and use the data and samples to perform various laboratory studies to explore the mechanisms of adverse drug reactions affecting the skin. Participation involves consenting and providing samples as outlined, with no therapeutic procedures. The study began in September 2018 and is expected to continue until 2028.

Researchers are studying dovramilast, an experimental drug not yet approved for leprosy type 2 reaction erythema nodosum leprosum, ENL, to compare its effects with current standard treatments. The study focuses on adults with moderate to severe acute or recurrent leprosy type 2 reaction to evaluate the safety and efficacy of two doses of dovramilast, 100 mg and 150 mg. This Phase 2 trial aims to understand how well these doses improve skin lesions and assess any adverse effects. Participants will be randomly assigned to receive either 100 mg or 150 mg of dovramilast or standard care, which includes prednisolone or thalidomide in US sites only. The treatment period lasts 12 weeks, during which the responses to these interventions are monitored. The study is open-label, meaning both researchers and participants know which treatment is given. The trial includes a dose-ranging design to evaluate different strengths of dovramilast. During the 12-week trial, participants will undergo assessments including skin lesion evaluations, fever resolution, and neuropathy changes. Researchers will use the ENLIST severity scale and monitor the need for rescue medications. Safety is closely monitored by tracking adverse events. Additional follow-up up to 48 weeks will assess recurrences and drug exposure. Participants will be regularly evaluated with laboratory tests and photographic assessments to measure outcomes and ensure adherence.

Researchers are evaluating the safety, tolerability, and effectiveness of stem cell therapy for treating a variety of acute and chronic conditions. This multi-site, multi-arm study focuses on regenerative treatments using amniotic and umbilical cord stem cell rich tissue. The study covers conditions including autoimmune diseases, cardiovascular disorders, diabetes complications, integumentary diseases, musculoskeletal disorders, neurological and neurodegenerative disorders, pulmonary disorders, sexual dysfunction, urologic disorders, and viral illnesses. The goal is to measure improvements based on validated quality of life and condition-specific tools. Participants will receive injections of PrimePro or PrimeMSK stem cell products administered through condition-specific routes. Each study arm targets a particular group of conditions to compare outcomes against established research. The treatments are given once with follow-up visits planned to assess changes over time. No placebo or control group is used, and the study is non-randomized with open-label participation. During the study, participants will undergo various assessments such as the 36-Item Short Form Survey SF-36 for quality of life, condition-specific questionnaires like the DASH for arm and shoulder disabilities, IIEF-5 for erectile function, clinical COPD questionnaire, MMSE for mental state, OLearySant questionnaire for interstitial cystitis, Oswestry Low Back Pain Disability Questionnaire, and WOMAC for osteoarthritis. Follow-up evaluations occur at 6 and 12 months after treatment to monitor progress. The study includes safety monitoring and requires participants to be available for follow-up visits over this time frame.

Researchers are studying the Active Biopsy Guidance System, a new optical imaging device designed to assist doctors in deciding when and where to perform biopsies on mouth lesions. The study aims to evaluate and optimize the technical performance of this device and to provide an initial estimate of its accuracy compared to standard tissue pathology. This research is focused on adults with various oral lesions, including potentially malignant disorders and previous oral cancers. The Active Biopsy Guidance System consists of two main parts an optical mapping scope that shows a wide area of the mouth lining using colored light projections, and a high-resolution microendoscope that captures detailed images of small areas. A fluorescent dye called proflavine hemisulfate is applied to the mouth tissue to enhance image quality. This device is assessed as a diagnostic tool to improve biopsy guidance. Participants will undergo imaging with the device, where pictures of the mouth lining are taken with and without the dye. The study will measure the devices sensitivity and specificity in detecting abnormal tissue compared to biopsy results. The trial involves a single group of participants and continues through to study completion, with ongoing monitoring lasting about one year. The research team monitors participants carefully to understand the devices performance and safety.