Contact Dermatitis

Researchers are evaluating the effectiveness and safety of GX-03, a topical ointment, in adults with moderate to severe atopic dermatitis, also known as eczema. This Phase 2, randomized, double-blind, vehicle-controlled study plans to enroll up to 120 adults aged 18 to 80, with the possibility of expanding to 200 based on interim review by an Independent Data Monitoring Committee. The study focuses on improvements in disease severity, itch, and patient-reported eczema symptoms. Participants will be randomly assigned to receive either GX-03 ointment or a matching vehicle control ointment. The assigned treatment will be applied topically to affected skin areas at least twice daily for eight consecutive weeks. The study includes an adaptive design, with an interim assessment after about 50 participants complete the 8-week treatment or withdraw early, which could lead to continuation, expansion, or stopping of enrollment based on pre-set criteria. During the study, participants will attend visits at baseline, Week 4, and Week 8 for assessments using validated tools such as the Investigator Global Assessment, Eczema Area and Severity Index, Peak Pruritus Numeric Rating Scale, and Patient-Oriented Eczema Measure. Safety will be monitored through adverse event reporting, medication reviews, and weekly safety check-ins. The primary outcome is the change in Investigator Global Assessment at Week 8, and total participation will last for the 8-week treatment period.

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.

Researchers are evaluating SHR-1894, a drug administered by single subcutaneous injection, in healthy adults aged 18 to 45 years. This Phase I clinical trial aims to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-1894. The study compares different doses of SHR-1894 injection with a placebo injection under controlled conditions. Participants will be randomly assigned to receive either SHR-1894 injection at varying doses or a placebo injection. Both participants and researchers will be unaware of the assigned treatment to ensure unbiased results. The study includes a follow-up period lasting up to 85 days to monitor effects and drug behavior in the body. During the trial, participants will undergo physical exams, vital sign checks, ECGs, chest X-rays, abdominal ultrasounds, and laboratory tests before and after treatment. Researchers will track any adverse events, measure drug concentrations in the blood over time, and assess immune responses. The total participation time covers screening, dosing, and monitoring visits spread across nearly three months.

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 STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in participants with advanced solid tumors that have high antigen levels. This open-label, multicenter Phase 12 study aims to assess the safety, tolerability, and early clinical activity of STAR0602 given alone and in combination with chemotherapy for these tumors, which have limited effective standard treatments. The trial includes participants with unresectable, locally advanced, or metastatic solid tumors, including specific subtypes like NSCLC and colorectal cancer. The study has two parts Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine the maximum tolerated dose and safety profile. Phase 2 uses the recommended dose from Phase 1 to further evaluate safety and preliminary effectiveness, measuring tumor responses and disease control. Chemotherapy drugs like Irinotecan and Docetaxel may be combined with STAR0602, and treatments are administered by infusion following defined cycles. Participants will undergo multiple assessments including safety monitoring for adverse events and serious adverse events up to three years. Researchers will measure tumor response rates, duration of response, disease control rate, progression-free survival, and other pharmacokinetic parameters. Study visits will include treatment administration, laboratory tests, and evaluations to track the therapys effects and tolerability over time. The total participation period may extend up to three years for follow-up and monitoring.

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.

This research study is evaluating the medicine abrocitinib in children aged 6 to less than 12 years with moderate-to-severe eczema. The purpose is to find out if abrocitinib improves eczema symptoms and is safe for this age group. Participants will be randomly assigned to receive either abrocitinib or a placebo for 16 weeks. The study is conducted as a phase 3, randomized, double-blind trial and will last about 24 weeks in total. Participants will receive abrocitinib or placebo as a liquid oral suspension. During the study, an electronic diary resembling a cell phone will be used to collect questionnaire information, remind participants to take their medicine daily, and record research data. Participants will also wear a wrist device similar to a childrens wristwatch to monitor scratching caused by eczema. The study includes laboratory tests, physical exams, and vital sign checks before and throughout the study. Participants will visit the clinic for study visits and receive follow-up calls from study doctors or nurses to monitor their health. Questionnaires will assess eczema symptoms, and physical measures such as height, weight, temperature, blood pressure, and heart rate will be tracked. The main outcomes measured include improvements in eczema severity and itchiness at Week 12, with safety and health closely monitored during the entire 24-week study period.

Researchers are evaluating the impact of lebrikizumab treatment on the overall well-being of adults with moderate-to-severe atopic dermatitis in real-world clinical settings across Europe. The study aims to measure health-related well-being using the World Health Organization Well-being Index WHO-5 and to assess lebrikizumabs effectiveness, safety, treatment satisfaction, and long-term effects on symptoms, fatigue, work impairment, skin relationships, and overall quality of life. Participants prescribed lebrikizumab as part of their usual care will be observed for 104 weeks. This is a non-interventional, observational study where data on participants receiving lebrikizumab will be collected according to routine clinical practice without altering their treatment. The study focuses on tracking health and symptom control over this two-year period. During the study, participants will undergo regular assessments of their well-being, eczema severity, itch and skin pain intensity, fatigue, sleep quality, and adverse events. Researchers will use validated scales including WHO-5, Eczema Area and Severity Index EASI, Investigator Global Assessment IGA, Patient-Oriented Eczema Measure POEM, and Numerical Rating Scales for pruritus, skin pain, and fatigue. Safety and treatment satisfaction will also be monitored throughout the 104 weeks of observation.

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 evaluating the safety and effectiveness of different doses of IMG-007 compared to placebo in adults with moderate-to-severe active atopic dermatitis. This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to understand how well IMG-007 works and its safety profile over a period of up to 48 weeks. Participants will receive subcutaneous injections of IMG-007 or placebo according to the study protocol. The study includes multiple dose regimens of IMG-007 and placebo groups, with some placebo participants crossing over to receive IMG-007 later. Treatments follow a parallel group design where different groups receive different doses or placebo. During the study, participants will undergo assessments including Eczema Area and Severity Index EASI scoring and Investigator Global Assessment for Atopic Dermatitis vIGA-AD at baseline and Week 24. Researchers will monitor treatment-emergent adverse events throughout the study. Participants will be followed for up to 48 weeks to evaluate changes in skin condition and safety outcomes during and after treatment.