Rash

Researchers are evaluating the safety and potential effectiveness of a topical treatment called ATR04-484 for patients experiencing moderate to severe skin rash caused by EGFR inhibitor therapy. This Phase 12, multicenter, randomized, and blinded trial compares ATR04-484 to a placebo vehicle in adults with EGFRi-related dermal toxicity primarily affecting the face, and possibly the neck, chest, and back. The study aims to assess the safety, bioavailability, pharmacodynamics, and preliminary treatment effects of ATR04-484. The trial involves two patient cohorts. The first cohort receives a single 4 g application of ATR04-484 or vehicle to the affected areas followed by a 7-day observation period, potentially continuing with daily applications for 28 days. The second cohort receives daily 4 g applications for 28 days. Both cohorts are followed for 28 days after completing treatment. Clinical assessments will evaluate skin toxicity severity, itching, pain, and quality of life using standardized scales. Participants will apply the study treatment daily as directed and attend clinic visits for evaluations and sample collections. Researchers will monitor safety and tolerability as the primary outcome over 57 days, along with secondary measures including skin rash severity, pruritus, and quality of life. Bioavailability of the topical agent will also be assessed. The study duration includes treatment and follow-up periods to thoroughly monitor effects and safety.

Researchers are evaluating a new artificial intelligence AI tool designed to assist primary care providers in assessing skin conditions. This AI-powered dermatology image reference app works with a smartphone to provide reference images, helping providers make diagnoses using their medical training. The study aims to compare diagnoses made by primary care providers using the AI tool to those of a panel of dermatologists, considered the gold standard. The research is supported by the Advanced Research Projects Agency for Health ARPA-H and focuses on improving diagnostic accuracy and care in real-world clinical settings. The study involves primary care providers using the Belle AI tool, which analyzes images captured via a smartphone app and identifies over 2,000 skin conditions based on a large image database. Providers use the app during patient visits to capture images and receive differential diagnoses, which they review before making final decisions. After the initial visit, participants receive notifications to submit follow-up images using the app over a two-week period. Providers reassess diagnoses based on updated AI analysis, and follow-up visits may be scheduled or canceled depending on results. Providers receive training on the app and give feedback through surveys. Participants present with a primary dermatological complaint and consent to study procedures, including using the smartphone app to submit images. Researchers monitor diagnosis accuracy compared to a dermatology review committee consensus and assess economic impact and provider experience. The study lasts about 14 days per participant, with ongoing documentation in electronic medical records and continuous case review to determine care needs or resolution.

Researchers are studying skin manifestations that occur during Covid-19 infection, with a special focus on chilblains, a frequent and specific type of acral lesion. The goal is to better understand these skin symptoms and their underlying causes, which may involve direct viral effects or vascular issues like microthrombosis or vasculitis. Insights from this study could also help explain other systemic symptoms seen in Covid-19 patients. The study involves characterizing chilblains through clinical and dermoscopic examination. Researchers will also perform non-invasive vascular assessments and analyze immune and blood clotting factors in patients diagnosed with Covid-19. These evaluations are conducted at the CHU of Nice to explore the relationship between skin signs and vascular or immune changes. Participants will have their skin symptoms monitored clinically over three months. Additional assessments include histology, biological tests, and non-invasive vascular examinations during this period. The study aims to gather a detailed profile of skin manifestations and related vascular and immune responses, contributing to a better understanding of Covid-19s effects on the skin and possibly systemic health.

This trial investigates whether taking a nutritional supplement daily for two months can improve skin health measures in women aged 45 to 65 years. It is a national, single-center, double-blind, randomized pilot study designed to compare a food supplement against a placebo, with safety overseen by the sponsor. The study focuses on skin aging and hair and skin condition in healthy adult women with normal to dry skin. Participants will receive either a powder food supplement or a matching placebo to dissolve in water, taken once daily for 56 days. The placebo resembles the active supplement in taste and appearance, both provided as orange-flavored instant drinks in sachets. The study includes visits at the start, after 28 days, and after 56 days of supplementation to monitor progress. Throughout the trial, participants will keep a diary to record skin status and any side effects. Researchers will assess skin physiological parameters at baseline, day 28, and day 56. They will also evaluate subject satisfaction, skin and hair quality, and monitor any adverse events during the full study period to understand the supplements effects and tolerability.

Researchers are evaluating whether a higher dose of cetirizine provides better relief than the standard dose for adults with acute urticaria, a condition causing sudden itchy wheals. This clinical trial aims to understand if increasing cetirizine to 40 mg daily improves symptoms faster and is safe over a short period. The study also explores side effects and helps reduce unnecessary steroid use in treating this condition. Participants are randomly assigned to one of two groups one taking the standard 10 mg dose once daily, and the other taking a higher 40 mg dose split into two 20 mg capsules daily. Both groups take their assigned medication for 7 days, recording their daily symptoms. Follow-up visits occur on Day 3, Day 7, and Week 6 to assess symptom improvement and safety. The study uses capsules that look identical to maintain fairness. Before and after treatment, participants have blood tests to check liver and kidney function. Researchers monitor symptoms using validated tools and track the need for rescue medications like corticosteroids. The main outcomes focus on how quickly symptoms resolve and changes in urticaria activity. The study lasts through the follow-up at Week 6 to observe longer-term effects and any recurrence of symptoms.

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 investigating how the skin and gut microbiomes change over time in adults who have suffered burn injuries compared to healthy individuals. The study focuses on understanding microbial imbalances that may occur not only at burn sites but also on non-burned skin and the gut. This observational cohort study aims to explore the links between these microbiome changes, skin-barrier recovery, and systemic immune responses, enrolling 660 participants including 600 burn patients and 60 healthy controls. Burn patients will provide skin swabs from both burned scars and matched non-burned skin, stool samples, and undergo skin physiological measurements at five time points baseline within 7 days after hospital admission, 3 months, 6 months, 12 months, and 24 months after injury. Healthy controls will provide skin and stool samples only once at baseline. Sample analysis includes 16S ribosomal RNA gene sequencing for microbial profiling and functional prediction using PICRUSt2. Blood tests for inflammatory markers such as C-reactive protein and erythrocyte sedimentation rate will also be conducted. Participants will undergo assessments including transepidermal water loss, skin hydration, pH, erythema, and elasticity using standardized instruments at each time point. The study will monitor changes in skin and gut microbiome diversity and function, as well as skin barrier health and systemic inflammation over two years. These comprehensive evaluations aim to provide insights into burn-related microbial changes and their impact on recovery, potentially guiding future therapeutic strategies in long-term burn care.

This research aims to determine how bathing affects physiological measures such as heart rate, body temperature, oxygen levels, skin condition, bilirubin levels, and comfort in newborn infants receiving phototherapy for jaundice. Phototherapy is the common treatment for neonatal jaundice, which occurs frequently in newborns and can lead to serious complications if untreated. The study explores whether bathing before phototherapy can reduce side effects like skin rashes and improve infant comfort. The study compares two groups of newborns those who receive a bathtub bath before phototherapy and those who receive standard care without additional bathing. Phototherapy treatment involves exposing infants to light to lower bilirubin in the blood. The bathing method studied involves using a baby bathtub and baby shampoo. The experimental group gets the bath before starting phototherapy, while the control group follows routine care without extra intervention. Participants will be monitored with multiple assessments including heart rate, respiratory rate, body temperature, oxygen saturation, skin moisture, and skin condition scores at several time points before and after bathing or phototherapy treatment. Bilirubin levels will be measured before treatment and 24 hours after phototherapy begins. Comfort levels will also be evaluated at set intervals. The study runs from hospitalization through six hours post-intervention, with detailed physiological and skin condition tracking to assess the effects of bathing on infants receiving phototherapy.

Researchers are evaluating the effects of liquid vitamin C and glutathione supplements on improving human skin condition and reducing oxidative stress. This trial is a single-center, placebo-controlled, double-blinded, parallel study involving healthy adults aged 18 to 65 years. The study aims to assess changes in skin beauty and antioxidant markers over a 12-week period. Participants will be randomly assigned to receive either a vitamin C and glutathione liquid sachet or a placebo sachet. Each participant is instructed to consume one sachet daily for 12 consecutive weeks. The trial includes baseline measurements before starting the supplement and follow-up assessments at 4, 8, and 12 weeks. Blood samples will be collected at the beginning and end of the study to evaluate antioxidant levels. Throughout the study, participants will undergo skin measurements and complete self-assessment questionnaires to monitor skin tone, spots, UV spots, hydration, redness, melanin index, elasticity, brown spots, wrinkles, texture, and collagen density. Researchers will also measure antioxidant capacity and related enzymes from blood samples. The total participation duration is 12 weeks, during which safety and effectiveness of the supplements will be monitored.

Researchers are evaluating the safety and tolerability of an oral drug called DF-003 in patients with ROSAH syndrome, a condition involving retinal dystrophy, optic nerve swelling, enlarged spleen, lack of sweating, and migraine headaches. This Phase Ib, open-label study will enroll up to 12 patients to investigate how the drug is processed in the body and its effects on the disease. The study aims to better understand DF-003s safety profile and biological activity in this rare condition. Participants will receive DF-003 orally once daily for 28 days. The dosing starts with higher loading doses of 140 mg on the first three days, followed by a maintenance dose of 45 mg from Day 4 through Day 28. The drug is taken in the morning with water. After completing the dosing period, patients will be followed for an additional 8 weeks to monitor ongoing effects and safety. During the study, patients will have regular assessments to monitor eye inflammation signs such as macular edema and optic nerve swelling, along with blood tests measuring inflammatory markers and drug levels. Safety will be closely monitored by recording adverse events from baseline through Day 78. The study includes detailed pharmacokinetic sampling to understand how DF-003 behaves in the body. Participation spans about 11 weeks from the start of treatment through follow-up evaluations.