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 laser's 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 laser's 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 Investigator's 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 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.

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.

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 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 conducting a first-in-human study to evaluate BG-A3004, a biological treatment being studied for safety, tolerability, pharmacokinetics, immunogenicity, and pharmacodynamics. The trial includes healthy participants and patients with immune-mediated skin diseases such as alopecia areata, cutaneous lichen planus, and nonsegmental vitiligo. This phase 1, randomized, double-blind, placebo-controlled study aims to better understand how BG-A3004 behaves in the body and its effects in these groups over about three years. The study has two parts: Part A involves healthy participants receiving a single subcutaneous dose of BG-A3004 or placebo, with sequential dose escalation. Part B includes patients with immune-mediated skin diseases receiving multiple subcutaneous doses of BG-A3004 or placebo across increasing dose levels. Part A participants get one dose, while Part B participants receive four doses. Safety follow-up continues for 168 days after the last dose in both parts. Participants will undergo medical evaluations, laboratory tests, and cardiac monitoring before and during the study. Researchers will monitor adverse events and serious adverse events for up to 24 weeks in Part A and 36 weeks in Part B. They will also measure drug concentration, half-life, and antibody formation against BG-A3004. The total study duration is approximately three years, including dosing, safety follow-up, and assessments to understand how the drug interacts with the body and its safety profile.

Researchers are evaluating the safety and effectiveness of Oleogel-S10 gel in treating skin wounds caused by two inherited forms of epidermolysis bullosa (EB), called junctional EB (JEB) and dystrophic EB (DEB), specifically in the Japanese population. This trial aims to find out if Oleogel-S10 gel can close wounds or reduce their size within 45 days, assess its safety, and measure how much of the gel enters the bloodstream. Both children and adults are invited to join this study. Participants apply Oleogel-S10 gel to their EB wound dressings at least once every four days for 45 days in Part 1 of the study. They visit the clinic every two weeks for checkups and tests during this period. Those who complete Part 1 may choose to continue in Part 2, where they keep receiving Oleogel-S10 gel until it becomes available for purchase in Japan or until the study is stopped by the company. During the study, participants will have regular clinic visits for examinations and tests to monitor wound healing, safety, and drug exposure. Researchers will evaluate the gel's effect on wounds up to 45 days in Part 1 and up to 90 days in Part 2. Safety and tolerability will be assessed throughout the study, which may continue until 2029. Participants will be supervised closely and asked to follow all study instructions and procedures.