Rosacea

Researchers are conducting a phase 2b, multicenter, randomized, double-blind, placebo-controlled study to evaluate camoteskimab in adults with moderate-to-severe atopic dermatitis. The study includes both treatment-naive participants and those who have had an inadequate response to previous biologic therapies, aiming to assess the effectiveness and safety of camoteskimab for this condition. The study has two parts. In Part 1, lasting 24 weeks, participants are randomly assigned to receive one of three doses of camoteskimab or a placebo, all given by subcutaneous injection. In Part 2, which is an extension period, all participants will receive camoteskimab. This design allows comparison of different doses and the placebo before all receive the active treatment. Participants will undergo regular assessments including evaluation of eczema severity, body surface area affected, and itch intensity using specific scales like the Eczema Area and Severity Index EASI and Peak Pruritus Numerical Rating Scale PP-NRS. Researchers will monitor changes from baseline over 24 weeks. Safety and adherence will be closely followed throughout the study, which is planned to continue until April 2028.

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 AIs 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 effectiveness and safety of baricitinib for treating severe or very severe alopecia areata, a form of hair loss, in children aged 6 to less than 18 years. This Phase 3 clinical trial aims to better understand how baricitinib works in this young population with this condition. The study is sponsored by Eli Lilly and Company and focuses on pediatric patients with a history of severe alopecia areata. Participants are randomly assigned to receive either a high dose or low dose of baricitinib taken orally, or a placebo. The study is divided into four periods a 5-week screening period to determine eligibility, a 36-week double-blind treatment period where participants receive the assigned study medication, an approximately 2-year long-term extension period for ongoing treatment, and a 4-week post-treatment follow-up. Some participants may continue treatment for up to a total of 180 weeks if eligible after the extension period. Throughout the study, participants undergo regular assessments including measurement of hair loss severity using the Severity of Alopecia Tool SALT score, patient-reported outcomes related to scalp hair and eyebroweyelash hair loss, and quality of life questionnaires. Safety and pharmacokinetics of baricitinib are also monitored. The primary outcome is to measure the percentage of participants achieving a SALT score of 20 or less by week 36. Participants receive careful monitoring during and after treatment, with the total study duration extending over multiple years.

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 skins 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 in both healthy adults and patients with immune-mediated skin diseases. The study aims to assess safety, tolerability, how the body processes the drug pharmacokinetics, immune response immunogenicity, and drug effects pharmacodynamics after single and multiple doses. The research includes healthy participants and patients with conditions like alopecia areata, cutaneous lichen planus, and nonsegmental vitiligo. Participants will be divided into groups receiving different dose levels of BG-A3004 or matching placebo. Healthy participants Part A will receive a single subcutaneous dose, while patients with skin diseases Part B will receive multiple doses. Dose levels will increase sequentially to study effects. The treatment duration is one dose for healthy participants and four doses for patients. After the last dose, safety follow-up will continue for 168 days. During the study, participants will undergo medical evaluations including physical exams, lab tests, and cardiac monitoring to ensure safety. Researchers will track adverse events and measure drug concentrations over up to 24 weeks for healthy participants and 36 weeks for patients. Immunogenicity and pharmacodynamic responses will be monitored. The total study duration is about three years, covering treatment, follow-up, and observation periods.

Researchers are evaluating the safety, tolerability, and early effectiveness of KB111, a topical treatment, in both pediatric and adult participants with Hailey-Hailey Disease HHD. This open-label study aims to better understand how KB111 works for managing HHD skin lesions by directly applying the investigational treatment and monitoring its effects over time. Up to 7 participants aged 12 years and older will apply KB111, a gel containing a non-integrating herpes simplex virus vector with the functional ATP2C1 protein, to their skin lesions for 12 weeks. The treatment will be administered at home by a trained person. Throughout the study, investigators or designees will contact participants weekly to check for any side effects or changes in their health or treatments. After the 12-week treatment, participants will have a safety follow-up visit 4 weeks later. During the study, participants will be assessed through investigator evaluations, patient-reported impressions of lesion severity, and molecular analysis of skin biopsies to measure how the treatment affects their condition. Safety and tolerability of KB111 will be monitored closely throughout the treatment and follow-up periods. The total study duration includes 12 weeks of treatment plus the 4-week safety follow-up, with frequent contact to support participant safety and collect data on treatment effects.

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 gels 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 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.