Vitiligo

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 the safety and effectiveness of GIA632 in adults aged 18 years and older with non-segmental vitiligo (NSV). This Phase 2b, multicenter, randomized, double-blind, placebo-controlled study aims to identify the optimal dose of GIA632 for further testing in a Phase 3 program. The study focuses on assessing how GIA632 affects vitiligo by comparing various doses against a placebo. Participants will receive GIA632 or a placebo during a 48-week core treatment period. The study includes multiple groups receiving different doses of GIA632, each administered over the same time frame. After the core period, an extension phase will assess the longer-term safety and effectiveness of the treatment. Throughout the study, participants will undergo regular assessments, including measurements of vitiligo severity using the Facial Vitiligo Area Scoring Index (F-VASI) and Total body Vitiligo Area Scoring Index (T-VASI) at baseline and multiple intervals up to week 48. Researchers will also evaluate improvements using the Vitiligo Noticeability Scale. Safety and efficacy will be monitored during and after treatment, with the total participation lasting at least 48 weeks during the core and extension periods.

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 drug's 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 cream's 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 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 tolerability and side effects of LY4005130 in adults with non-segmental vitiligo (NSV). This phase 2 study compares LY4005130 to a placebo and aims to understand how the study drug affects the body and how the body processes it. The study is sponsored by Eli Lilly and Company and focuses on participants with NSV involving specific body surface areas. Participants will receive either LY4005130 or a placebo through intravenous (IV) infusions. The study includes a 24-week treatment period with randomized, double-blind administration of the study drug or placebo. The treatment effects will be compared primarily by measuring changes in facial vitiligo area, with additional assessments of total vitiligo area and biological markers from skin biopsies and blood samples. The study lasts about 48 weeks including screening. During this time, participants will undergo blood tests to monitor drug processing and effects, skin biopsies for gene expression analysis, and other evaluations of vitiligo severity using scoring indexes. Safety and response will be closely monitored, and the main outcome measured is the percentage of participants achieving significant improvement in facial vitiligo area at week 24.

Vitiligo is a long-term autoimmune condition where the body's immune system attacks skin cells that produce pigment, causing patches without color. This study is focused on adults with nonsegmental vitiligo, where patches appear symmetrically on both sides of the body. Researchers aim to learn how safe and tolerable the drug zasocitinib is, and how well it works for this condition. Participants will be randomly assigned to receive different doses of zasocitinib capsules or a placebo. Those initially on placebo will switch to a medium or high dose of zasocitinib after about six months. The treatment period lasts up to 52 weeks with several dosage groups including low, medium, and high doses of zasocitinib. During the study, participants will visit the clinic 11 times for assessments. Researchers will measure improvements using the Facial Vitiligo Area Scoring Index (F-VASI) and the Total Vitiligo Area Scoring Index (T-VASI). Safety, tolerability, and effectiveness will be monitored throughout the study, with the main outcome assessed at week 24. Participants will be closely followed to track treatment responses and any side effects.

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.