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 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.

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 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 STAR0602, a selective T cell receptor targeting bifunctional antibody-fusion molecule, in adults with advanced solid tumors that are antigen-rich. This open-label, multicenter Phase 1/2 study aims to assess the safety, tolerability, and preliminary clinical activity of STAR0602 in participants with unresectable, locally advanced, or metastatic solid tumors where standard therapies are not effective or suitable. The study has two parts: Phase 1 Dose Escalation and Phase 2 Dose Expansion. In Phase 1, STAR0602 is given intravenously to determine safety, the maximum tolerated dose, and the recommended dose for Phase 2. In Phase 2, participants receive STAR0602 at the established recommended dose to further evaluate safety and clinical activity. Clinical activity is measured by tumor response rates, duration of response, disease control, and progression-free survival. Participants will receive STAR0602 infusions in cycles lasting 28 days. Researchers will monitor safety by tracking dose-limiting toxicities, adverse events, and serious adverse events for up to three years. Tumor responses and survival outcomes are also assessed over this period. Pharmacokinetic measures and anti-drug antibody formation will be evaluated at specified cycles. The total study duration and follow-up can extend up to three years to gather comprehensive safety and activity data.

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 studying the effects and safety of abrocitinib, a test medicine, in children aged 6 to less than 12 years who have moderate-to-severe eczema. The study is designed to compare abrocitinib with a placebo, a look-alike medicine without active ingredients, to better understand how well abrocitinib works for this condition. The research will last about 24 weeks, including 16 weeks of treatment. Participants will be randomly assigned to receive either abrocitinib or placebo as a liquid oral suspension daily for 16 weeks. The study uses questionnaires and an electronic diary on a device similar to a cellphone to track eczema symptoms and remind participants to take their medicine. Children will also wear a wrist device resembling a watch to detect scratching caused by eczema. Health will be monitored with lab tests, physical exams, and vital signs throughout the study. During the study, participants will visit the clinic for assessments and receive calls from the study doctor or nurse to check on their condition. Questionnaires will help measure eczema severity and itchiness, while the wrist device tracks scratching behavior. The main outcomes measured include improvement in skin condition and itch severity by week 12. Safety and health monitoring will continue through the study, ensuring detailed observation of treatment effects and participant well-being.

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 lebrikizumab's 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 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 evaluating the efficacy and safety of different dose regimens of IMG-007 in adults with moderate-to-severe active atopic dermatitis (AD). This Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel group study aims to assess the effects of IMG-007 compared to placebo over up to 48 weeks. The study targets adults with significant AD symptoms who have not responded well to topical treatments or cannot use them. Participants will receive subcutaneous injections of IMG-007 at various doses or placebo according to the study protocol. Those initially receiving placebo may later switch to IMG-007. The treatment period lasts up to 48 weeks, with dosing and administration closely monitored. The study includes multiple experimental groups with different IMG-007 dose regimens and placebo comparator groups. During the study, participants will have regular assessments including skin evaluations, symptom scales such as the Eczema Area and Severity Index (EASI) and Investigator's Global Assessment (vIGA-AD), and safety monitoring for adverse events. The primary outcome is the mean percent change in EASI score at Week 24. Secondary outcomes include various measures of symptom improvement and safety. Participants will be followed through the treatment and assessment periods to evaluate response and tolerability.