Toxic Epidermal Necrolysis

Researchers are evaluating camoteskimab, a drug being studied in adults with moderate-to-severe atopic dermatitis. This phase 2b study is multicenter, randomized, double-blind, and placebo-controlled, aiming to assess the drug's effects compared to placebo. Participants include those who have not been treated before and those who have had an inadequate response to previous biologic therapies. The study has two parts: Part 1 is a 24-week period where participants are randomly assigned to one of four groups receiving one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, an extension period, all participants will receive camoteskimab. This design allows researchers to compare the drug doses with placebo initially and then provide treatment to all participants. Participants will be involved for at least 24 weeks in the placebo-controlled phase and beyond during the extension. They will undergo assessments including the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), and peak itch ratings. Researchers will measure changes in eczema severity, itch intensity, and skin condition over time. Safety and adherence will be monitored throughout the study period to evaluate the drug's effects and tolerability.

This research aims to evaluate the accuracy of the Belle.ai software in diagnosing common dermatologic diseases across different skin tones. The software uses deep learning technology to analyze clinical images of skin conditions and provides a differential diagnosis from a database of over 2,000 skin conditions based on more than 500,000 images. The study will determine how well the AI-generated diagnoses match those of dermatology experts. Participants who consent will have three images taken of their skin condition using the Belle.ai software. These images will be de-identified and uploaded into the system, where the software will generate a single list of possible diagnoses. Dermatology experts will then review the cases to compare their diagnoses with the AI results. The study will be conducted at dermatology clinics within the Advocate Health system. During the study, images will be captured and uploaded securely without any personal identifiers. The Dermatologic Review Committee will assess the concordance between the AI's primary diagnosis and expert opinions, aiming for greater than 80% agreement. Participants will not need to complete any additional forms, and their involvement primarily involves image capture during their clinic visit. The main outcome measured is the agreement between AI and physician diagnoses on the day of image capture.

Researchers are studying a Chinese herbal Complementary and Alternative Medicine (CAM) product containing 1% menthol to help temporarily relieve pain and itching after radiotherapy in female patients with newly diagnosed breast cancer. The study focuses on skin toxicity that can occur during and after radiotherapy treatment. This trial is interventional and sponsored by the University of Miami. Participants will apply the CAM product topically on the chest wall once a day and once at night during their standard radiotherapy course, which lasts up to 6 weeks. Treatment with the CAM product continues for an additional 8 to 12 weeks (weeks 14 to 18) after completing radiotherapy. This regimen aims to assess the product's ability to reduce skin-related side effects. During the study, participants will be monitored for skin toxicities up to 18 weeks, using measures such as the proportion of patients free from significant skin problems, SD-16 scores, FACT-B quality of life scores, and high-sensitivity C-reactive protein levels up to 6 weeks. The study involves regular assessments of symptoms and skin condition, with all study-related care provided under medical supervision throughout the treatment and follow-up periods.

Researchers are creating a network of hospitals, labs, academic institutions, and healthcare organizations to provide annotated biospecimens for various types of medical research and education. These biospecimens will be used for biomarker discovery, diagnostic test development, therapeutics research, and training of researchers and physicians. Participants may be healthy or have medical conditions relevant to ongoing research needs. The study involves collecting remnant specimens originally obtained for clinical testing or specimens collected specifically for research, including biofluids, tissues, and cells. Participants may be identified during clinical care or recruited through outreach programs. Biospecimens may be distributed to various research entities such as academic institutions and companies for diverse research uses, including genetic testing, cell line development, and long-term storage. Participants may undergo minimal risk screening activities and provide biospecimens as needed. The research team will collect data over a 10-year period to support novel research uses. Biospecimens may be used for multiple research and educational purposes, including training laboratory technicians and physicians. The study includes participants aged 1 to 89 years and involves assessment of health status through medical record reviews and clinical exams when blood collection is needed.

Pemphigus diseases are serious, chronic autoimmune conditions that cause blistering due to the immune system attacking certain skin proteins. The two main types studied here are pemphigus vulgaris and pemphigus foliaceus. Researchers are evaluating a new personalized maintenance therapy involving rituximab infusions guided by antibody levels to see if this approach can better prevent disease relapses compared to the standard treatment. This is a phase 4 randomized study conducted by the University Hospital, Rouen, building on previous rituximab trials that led to regulatory approvals. Participants in the trial will receive initial treatment with rituximab and oral prednisone following French guidelines, with rituximab given at Day 1, Day 14, Month 12, and Month 18. One group will receive this standard regimen, while the experimental group will have their treatment adapted based on anti-desmoglein antibody levels. Additional rituximab infusions may be given at Month 6 or later if antibody levels remain high or increase, with up to two extra infusions per year allowed during the study. During the study, participants will be regularly monitored through blood tests for antibody levels and blood cells every three months for up to 7.5 years. Researchers will assess the number of disease relapses, time to relapse, duration of remission, quality of life, and rituximab exposure. The study will also track the total dose of rituximab and record safety outcomes. This long follow-up aims to understand if personalized maintenance with rituximab can reduce relapses and the need for corticosteroid treatment.

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 the effectiveness and safety of transcutaneous posterior tibial nerve stimulation (TENS) therapy in men with lifelong premature ejaculation. The trial compares TENS therapy alone, standard pharmacological treatment with dapoxetine, and a combination of both treatments. The study aims to answer whether combining these therapies improves outcomes compared to dapoxetine alone in adult men diagnosed with premature ejaculation attending clinics in Mexico City. Participants are randomly assigned to one of three groups: Group 1 receives TENS therapy plus a placebo pill; Group 2 receives dapoxetine 30 mg as needed plus placebo TENS therapy; Group 3 receives both TENS therapy and dapoxetine. The TENS therapy involves three weekly 30-minute sessions for 12 weeks, delivering a 20 Hz electrical current with adjustable intensity based on patient tolerance. Dapoxetine or placebo pills are taken 3 to 4 hours before sexual intercourse during the 12-week intervention. During the study, participants undergo evaluations including changes in intravaginal latency time measured at 12 and 24 weeks, clinical improvement assessments, and questionnaires such as the Premature Ejaculation Profile and Global Impression of Change. Safety is monitored through reported adverse events over 24 weeks. The study lasts at least six months, including a 12-week treatment period and a 12-week follow-up to assess lasting effects.

Researchers are evaluating the use of indocyanine green (ICG) angiography to identify skin areas at risk of necrosis during oncoplastic surgery or skin-sparing mastectomy in women with breast cancer or at high risk for breast cancer. Skin necrosis is a serious complication that can delay further treatment, require additional surgery, and negatively impact cosmetic outcomes and quality of life. This study aims to determine the sensitivity, specificity, and predictive values of ICG angiography in predicting postoperative complications. The study involves women undergoing oncoplastic breast-conserving surgery or skin/nipple-sparing mastectomy with immediate breast reconstruction using a prepectoral implant. ICG angiography will be performed at three key surgical points: before starting the procedure to visualize vascular anatomy, after breast tissue removal to assess flap viability, and after implant placement and wound closure. The SPY System with SPY-Q software will be used to capture these images. Participants will be monitored for postoperative complications up to one month after surgery. Researchers will assess vascularity before surgery, surgical planning, and intraoperative timing. The main outcomes include the accuracy of ICG angiography during surgery and its ability to predict postoperative complications. This observational study will help establish the value of ICG angiography in surgical decision-making and improving patient outcomes.

Researchers are evaluating the effectiveness and safety of combining methylprednisolone with two different JAK inhibitors, abrocitinib and tofacitinib, in treating toxic epidermal necrolysis (TEN). This early phase 1 study aims to compare these combinations to understand their impact on this severe skin condition. The study is open-label, non-randomized, and conducted at a single center. Participants receive methylprednisolone at a dose of 1 mg/kg of body weight per day combined with either abrocitinib 200 mg daily or tofacitinib 10 mg daily. Both treatments are given for a duration of two weeks. The study has two treatment arms, one for each JAK inhibitor, to assess their efficacy and safety when combined with methylprednisolone. During the study, researchers will monitor the time it takes for skin healing (reepithelization) over up to eight weeks. They will also observe any adverse events for up to twelve weeks. Participants will undergo regular follow-up visits and assessments, including monitoring blood parameters, liver and kidney function, to evaluate treatment effects and safety. The total participation duration varies depending on individual follow-up schedules.

Researchers are investigating the use of mesenchymal stromal cells (MSCs) as a new treatment for Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), which are rare, severe skin reactions usually caused by drugs. MSCs have shown promise in healing various conditions due to their ability to modulate the immune system and promote tissue repair, making them a potential strategy to improve healing and reduce complications in SJS and TEN. The study involves giving patients a single intravenous injection of adipose-derived stromal cells at a dose of 2 million cells per kilogram of body weight, administered within three days after hospital admission. This pilot Phase 1-2 open trial focuses on evaluating the safety and effectiveness of this treatment for patients hospitalized with confirmed SJS-TEN. The infusion is given once at day 0, and patients are monitored closely after treatment. Participants will be followed to assess safety by observing any adverse effects by day 10 and to measure the rate of skin healing by day 7 after the infusion. Additional evaluations include monitoring hospital stay duration, mucous membrane healing, immune response, infection rates, and tissue regeneration up to 12 months after treatment. The study also includes laboratory tests and skin biopsies to better understand treatment effects and long-term outcomes.