Vitiligo

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 the safety and effectiveness of GIA632 in adults aged 18 to 99 years with non-segmental vitiligo NSV. This randomized, double-blind, placebo-controlled Phase 2b study aims to understand the dose-response relationship of GIA632 and determine the best dose to advance to a Phase 3 study. Participants have NSV affecting specific body surface areas confirmed by physical examination. Participants are randomly assigned to receive one of four different doses of GIA632 or a placebo. The assigned treatment is administered over a 48-week core period. After this period, an extension phase assesses longer-term safety and efficacy of the study drug. The study compares changes in facial and total body vitiligo scores at various time points up to 48 weeks. Throughout the study, participants undergo assessments including Vitiligo Area Scoring Index VASI measurements on the face and body, and the Vitiligo Noticeability Scale VNS. These assessments occur at baseline and multiple follow-up visits up to week 48. Researchers monitor participants for treatment effects and safety during the entire study duration, which runs until 2030, ensuring detailed evaluation of GIA632 over time.

Researchers are studying the effects of MH004 ointment on people aged 12 to 75 who have non-segmental vitiligo, a condition that causes loss of skin color. This trial is a randomized, double-blind, placebo-controlled study aiming to assess the ointments safety, effectiveness, and how it behaves in the body. The main goal is to see how many participants achieve a 75% improvement in their facial vitiligo at 24 weeks. Participants will first go through a screening period to confirm eligibility. Then, during the 24-week double-blind treatment phase, they will be randomly assigned to apply either MH004 ointment or a placebo twice daily. Afterward, all participants enter a 28-week extended treatment phase where everyone applies MH004 ointment twice daily. Following treatment, there is a 4-week safety follow-up period to monitor participants. Throughout the study, participants will have regular assessments including measuring changes in the Facial Vitiligo Area Scoring Index and the Total Vitiligo Area Scoring Index at weeks 24 and 52. The study will also monitor any side effects or adverse events. Participants need to comply with scheduled visits, treatment routines, lab tests, and other procedures for the entire duration, which may last over a year including follow-up.

Researchers are studying vitiligo, a condition that causes loss of skin color, focused on the face and neck areas in adults aged 18 to 60 years. The study aims to evaluate whether the drug CGB-600 can reduce the severity of vitiligo in these areas and to monitor its safety. Participants will be randomly assigned to receive either the drug or a non-active gel vehicle in a double-blind setup to compare effects. Participants will apply the CGB-600 gel or the vehicle gel twice daily to the affected facial and neck areas for 24 weeks. The study includes eight clinic visits for checkups and tests throughout the treatment period. This is a phase 1 proof of concept trial designed to assess initial safety and effectiveness. During the study, participants will undergo regular assessments including safety monitoring for any medical issues and evaluation of vitiligo severity using the Facial Vitiligo Area Scoring Index F-VASI. The study tracks safety events from enrollment through the 24-week treatment. Participants must comply with study instructions and attend scheduled visits over the 24 weeks to support thorough evaluation of the drugs impact and safety profile.

Researchers are investigating the effects of vitamin D supplementation and topical fluoride treatments on people aged 12 to 45 who have vitamin D deficiency and early dental cavities called Initial Carious Lesions ICL. This trial aims to compare how these treatments influence the progression of ICL by measuring changes in the International Caries Detection and Assessment System ICDAS scores, concentrations of proteins in saliva, and the presence of cavity-causing bacteria over six months. The study is conducted as a randomized controlled trial at multiple outpatient centers. Participants are randomly assigned to one of three groups Group A receives vitamin D supplements and oral hygiene instructions Group B receives vitamin D supplements, topical fluoride application, and oral hygiene instructions and Group C, the control group with sufficient vitamin D levels, receives topical fluoride and oral hygiene instructions. Vitamin D supplements include weekly 50,000 IU doses for two months followed by daily maintenance doses of 5,000 IU for one month. Fluoride treatments involve professional application of 5% sodium fluoride gel for five minutes on affected teeth. During the six-month study, participants will have their dental health monitored through assessments of their ICDAS scores, saliva samples analyzed for protein levels using ELISA, and bacterial counts measured by PCR techniques. Researchers will also check serum vitamin D levels. Oral hygiene and diet counseling are provided. The study evaluates the progression of initial cavities, changes in saliva biomarkers, and oral bacteria to understand how these interventions impact dental caries management.

Vitiligo is a common chronic autoimmune skin condition causing white patches on the skin that can affect any area of the body and significantly reduce quality of life. Current treatments like topical medications, phototherapy, systemic therapy, and surgery often have limited success and high rates of recurrence. This research focuses on studying ruxolitinib cream, a JAK inhibitor, to understand what factors influence its effectiveness in treating vitiligo in a real-world setting. Participants in this observational study will use ruxolitinib cream twice daily. The study aims to assess the creams impact on vitiligo by measuring improvements in skin depigmentation using tools like the total vitiligo area scoring index T-VASI and the facial vitiligo area scoring index F-VASI over 24 weeks. Secondary assessments include patient-reported noticeability of vitiligo patches and quality of life changes. During the study, participants will be monitored at weeks 12 and 24 for changes in vitiligo severity and quality of life. Researchers will evaluate clinical differences between those achieving significant improvement and those who do not. Participants must agree to stop other vitiligo treatments during the study and use effective contraception if applicable. The total participation duration extends over 24 weeks with scheduled assessments to track treatment response and safety.

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 safety and side effects of LY4005130, a drug given through a vein, in adults with non-segmental vitiligo NSV. This study compares LY4005130 to a placebo to better understand how well the drug is tolerated. The trial is a Phase 2, randomized, double-blind study lasting about 48 weeks, including screening, to provide detailed information on treatment effects. Participants receive either LY4005130 or a placebo intravenously during the 24-week treatment period. Blood tests will be used to see how the drug moves through and affects the body. The study measures changes in vitiligo skin area using scoring indexes and also examines gene expression from skin biopsies. The comparison between the drug and placebo aims to provide clear insights into treatment effects. Throughout the study, participants will have assessments including blood tests and skin biopsies at the start and after treatment. Researchers will track side effects and changes in vitiligo by measuring the affected skin area. The study includes regular evaluations of drug levels in the blood and gene activity related to vitiligo. Participation involves about 48 weeks total, covering screening, treatment, and follow-up to monitor safety and response.

Vitiligo is a long-term autoimmune condition that causes the skin to lose its color due to the immune system mistakenly attacking pigment-producing skin cells called melanocytes. This leads to patches of skin with less or no pigment, often appearing symmetrically on both sides of the body in the nonsegmental form of vitiligo. The study aims to evaluate the safety, effectiveness, and tolerability of the drug zasocitinib in adults with nonsegmental vitiligo. Participants will receive oral capsules of zasocitinib at low, medium, or high doses for up to 52 weeks. Some participants will initially receive a placebo for 24 weeks, then switch to medium or high doses of zasocitinib for the remainder of the study. The placebo capsules look identical to zasocitinib but do not contain active medicine. The study uses a randomized, double-blind design with several experimental groups receiving different doses or placebo. During the study, participants will visit the clinic 11 times over one year. Researchers will assess the improvement in vitiligo using facial and total Vitiligo Area Scoring Index F-VASI and T-VASI at baseline and week 24. Safety and tolerability will also be monitored throughout. The primary outcome is the percentage of participants achieving at least 75% improvement in F-VASI at week 24. Secondary outcomes include other measures of vitiligo area improvement. Participants health and response to treatment will be closely followed until the studys end.