Acne

Researchers are evaluating the clinical effectiveness and safety of a 577 nm diode laser to treat non-inflammatory acne, specifically acne comedones. Acne vulgaris commonly affects adolescents and young adults, often causing scarring and lowered self-esteem. This study aims to explore laser treatment as an alternative to traditional topical and oral medications, which may have side effects or compliance challenges. The laser targets sebaceous glands and bacteria involved in acne development to reduce lesions. In this study, all patients receive sessions of the 577 nm diode laser treatment on one side of their face while the other side serves as an untreated control for comparison. The treatment focuses on reducing comedonal lesions without other interventions applied to the control side. This approach allows direct evaluation of the lasers effect within the same individual over time. Participants will be assessed clinically before and after treatment, with the main outcome being the reduction in the number of comedones measured over three months. Researchers will monitor safety and treatment responses during this period. The entire study involves adults aged 18 to 40 years who have at least 10 comedonal lesions on both sides of the face. This setup helps gather detailed information about the lasers potential in managing non-inflammatory acne.

Researchers are evaluating the overall benefit and tolerance of a cosmetic product called RV4133C - Formula JT2559 as complementary care alongside a topical medical treatment for facial acne. This study focuses on teenagers and young adults aged 14 to 24 with mild to moderate acne, comparing the tested product to a light moisturizing cream over two phases a 3-month associated treatment phase plus a 3-month maintenance phase. Participants will apply either the tested cosmetic product or a comparator moisturizing cream twice daily to the entire face while using the prescribed topical medical treatment during the first 3 months. After this associated treatment phase, they will continue applying the product alone for an additional 3 months during the maintenance phase. The study is randomized and investigator-blinded, aiming to assess efficacy and tolerance throughout these 6 months. During the study, researchers will evaluate the number of total acne lesions after 24 weeks, along with multiple other measures including Investigators Global Assessment, lesion counts at several timepoints, quality of life questionnaires, and assessments of post-inflammatory hyperpigmentation and erythema. Tolerance, patient satisfaction, compliance, and acne relapse will also be monitored. Participants can expect regular visits for assessments and questionnaires over the full 6-month study 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.

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.

This research aims to evaluate the safety and effectiveness of ELAPR002f injectable gel in adults with moderate to severe atrophic acne scars. These scars are flat or indented marks that remain after acne heals and can affect quality of life through reduced self-esteem and embarrassment. The study is a controlled, randomized trial including about 395 adults with scarring on both cheeks, conducted at multiple sites in the United States. Participants are divided into two cohorts. Cohort 1 receives ELAPR002f injectable gel openly, while Cohort 2 participants are randomly assigned to receive either ELAPR002f gel or a saline control via intradermal injections. Treatments are given on Days 1, 31, and 61. After the three treatment sessions over two months, participants are followed for up to 12 months to observe outcomes and any side effects. During the study, participants will have regular visits at a clinic or hospital for medical assessments, blood tests, and questionnaires to monitor their progress and any side effects. Researchers will measure the percentage of participants who achieve at least a 20% reduction in acne scar area and various safety parameters, including injection site responses and changes in vital signs and laboratory values. The total study duration for each participant can be up to 420 days.

Researchers are evaluating the effectiveness of trifarotene 50 microgram per gram cream compared to a vehicle cream in treating moderate acne vulgaris on the face and trunk in Chinese participants. This phase 3, randomized, double-blind, vehicle-controlled study aims to understand how well trifarotene works when applied once daily over 12 weeks in this population. Participants will be randomly assigned to apply either trifarotene cream or vehicle cream once daily in the evening for 12 weeks. The study includes two groups one receiving the active trifarotene cream and the other receiving the vehicle cream, both applied topically. This treatment period is the main phase of the trial where efficacy and safety are monitored. During the study, participants will attend visits to assess acne severity and lesion counts on the face and trunk, using Investigator Global Assessment IGA and Physician Global Assessment PGA scales. Researchers will track changes in inflammatory and non-inflammatory lesions from baseline to week 12, monitor adverse events, and evaluate skin tolerability at several points. Some participants will have plasma samples collected to measure drug levels. The total participation lasts 12 weeks with monitoring throughout this period.

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.