Rosacea

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 evaluating the safety and effectiveness of baricitinib for treating severe or very severe alopecia areata, a condition causing hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to determine how well baricitinib works in this young population, with careful monitoring of outcomes related to hair regrowth and patient well-being. Participants will be randomly assigned to one of three groups: a high dose of baricitinib, a low dose of baricitinib, or a placebo. The study includes four periods: a 5-week screening phase to determine eligibility, a 36-week double-blind treatment period where participants receive their assigned treatment, an approximately 2-year long-term extension to observe longer-term effects, and a 4-week follow-up after treatment ends. Some participants may continue to receive treatment after the extension for up to 180 weeks. During the trial, children will undergo regular assessments including the Severity of Alopecia Tool (SALT) score to measure hair loss, patient-reported outcomes on scalp hair, eyebrow, and eyelash hair, as well as evaluations of anxiety, depression, and quality of life. Blood tests will monitor drug levels and immune response. Participants will be closely followed throughout the study periods to track changes and ensure safety, with the total participation lasting over two years depending on extension eligibility.

Researchers are evaluating the effects of a fish oil concentrate called EPAX Omega 3-9-11 on skin function. This study aims to determine if this combination of long chain mono-unsaturated fatty acids and omega-3 can improve skin health by reducing inflammation, redness, and improving the skin's barrier function. The research involves healthy adults aged 35 to 65 with a history of atopic skin prone to redness or dryness. Participants will be randomly assigned to one of three groups: a placebo group taking 1g corn oil capsules, a low dose group receiving 2g of Omega 3-9-11 oil, or a high dose group receiving 4g of Omega 3-9-11 oil daily. They will take these capsules for three months, with measurements taken at the start, 6 weeks, and 12 weeks. During the study, participants will undergo biophysical measurements of their face and inner forearm to assess skin erythema (redness) and hydration. Researchers will also monitor skin health through the Omega-3 index and other skin parameters adjusted for placebo effects. The study includes safety monitoring and requires participants to avoid other fish oil or lipid-based supplements during the trial. The total participation lasts three months, with evaluations at regular intervals.

Researchers are conducting a first-in-human study to evaluate BG-A3004, a biological treatment being studied for safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics. The trial includes healthy participants and patients with immune-mediated skin diseases such as alopecia areata, cutaneous lichen planus, and nonsegmental vitiligo. This phase 1, randomized, double-blind, placebo-controlled study aims to better understand how BG-A3004 behaves in the body and its effects in these groups over about three years. The study has two parts: Part A involves healthy participants receiving a single subcutaneous dose of BG-A3004 or placebo, with sequential dose escalation. Part B includes patients with immune-mediated skin diseases receiving multiple subcutaneous doses of BG-A3004 or placebo across increasing dose levels. Part A participants get one dose, while Part B participants receive four doses. Safety follow-up continues for 168 days after the last dose in both parts. Participants will undergo medical evaluations, laboratory tests, and cardiac monitoring before and during the study. Researchers will monitor adverse events and serious adverse events for up to 24 weeks in Part A and 36 weeks in Part B. They will also measure drug concentration, half-life, and antibody formation against BG-A3004. The total study duration is approximately three years, including dosing, safety follow-up, and assessments to understand how the drug interacts with the body and its safety profile.

Researchers are evaluating the safety and effectiveness of Oleogel-S10 gel in treating skin wounds caused by two inherited forms of epidermolysis bullosa (EB), called junctional EB (JEB) and dystrophic EB (DEB), specifically in the Japanese population. This trial aims to find out if Oleogel-S10 gel can close wounds or reduce their size within 45 days, assess its safety, and measure how much of the gel enters the bloodstream. Both children and adults are invited to join this study. Participants apply Oleogel-S10 gel to their EB wound dressings at least once every four days for 45 days in Part 1 of the study. They visit the clinic every two weeks for checkups and tests during this period. Those who complete Part 1 may choose to continue in Part 2, where they keep receiving Oleogel-S10 gel until it becomes available for purchase in Japan or until the study is stopped by the company. During the study, participants will have regular clinic visits for examinations and tests to monitor wound healing, safety, and drug exposure. Researchers will evaluate the gel's effect on wounds up to 45 days in Part 1 and up to 90 days in Part 2. Safety and tolerability will be assessed throughout the study, which may continue until 2029. Participants will be supervised closely and asked to follow all study instructions and procedures.

Researchers are evaluating real-world treatment patterns and clinical outcomes in patients aged 12 years and older with moderate-to-severe atopic dermatitis who are receiving abrocitinib. The study aims to describe patient demographics and baseline characteristics over a 12-month observation period to better understand how abrocitinib is used in usual clinical practice conditions. Participants will be newly prescribed abrocitinib as decided by their physician during routine care. The study does not involve experimental treatments but observes how abrocitinib is used and its effects in everyday settings. There are no comparator groups or placebo treatments since this is an observational study. During the 12-month observation, researchers will track improvements in eczema severity using measures like the Eczema Area and Severity Index (EASI), Investigator's Global Assessment (IGA), and patient-reported outcomes such as the Peak Pruritus Numerical Rating Scale (PP-NRS). Data on treatment duration, quality of life, and symptom changes will also be collected. Patients' progress will be monitored at multiple time points including weeks 2, 4, 12, 16, 24, and 52.

Researchers are evaluating the effects of acupuncture on patients with refractory rosacea, a skin condition that causes persistent facial redness and flushing. This randomized, multicenter, sham-controlled clinical trial aims to determine whether acupuncture can effectively reduce facial erythema and flushing episodes compared to sham acupuncture. The study will enroll 104 participants aged 18 to 65 years who have not responded to conventional treatments. Participants will be randomly assigned to one of two groups: the acupuncture group or the sham acupuncture group. The acupuncture group will receive electroacupuncture treatment at specific points on the face, neck, and limbs with continuous waves at 1 Hz for 20 minutes per session, twice a week for 8 weeks (total of 16 sessions). The sham group will receive non-penetrating stimulation with blunt needles at the same locations and schedule, without electrical stimulation on facial points. The study consists of a 1-week baseline observation, an 8-week treatment phase, and an 8-week follow-up phase. Participants will attend five in-person visits at weeks 0, 4, 8, 12, and an online follow-up at week 16. During these visits, researchers will assess rosacea symptoms including redness, flushing severity, burning sensation, and telangiectasia using questionnaires and clinical evaluations. They will also monitor sleep quality and quality of life. Safety will be tracked through reports of treatment-related adverse events. The total participation duration is 17 weeks, including baseline, treatment, and follow-up periods.

Accurate assessment of skin pigmentation is important in dermatology to diagnose and manage various skin conditions. Traditional methods like visual inspection or Fitzpatrick skin type classification can be subjective, culturally biased, and often focus on lighter skin tones, which may lead to misdiagnosis or improper treatment for individuals with darker skin. This research aims to explore better, more objective ways to measure skin pigmentation using modern, non-invasive imaging technologies. The study includes two groups: healthy adults with diverse skin tones and adults with skin conditions who have active lesions being treated by a dermatologist. Researchers will use tools such as colorimetry and multispectral imaging to measure a value called the melanin index, which indicates the amount of pigment in the skin. They will compare this index across different body areas and among people with various skin tones and conditions. Participants will have a single baseline visit where several assessments will be performed, including Fitzpatrick skin type classification, Line-Field Confocal Optical Coherence Tomography, 3D multispectral imaging, colorimetry, skin barrier function testing, VISIA imaging, scar assessment scales, laser speckle contrast imaging, and Scarletred4 Vision measurements. Researchers will analyze these data to better understand skin pigmentation variation, aiming to improve diagnosis and management of skin diseases for all skin types.

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.