Atopic Dermatitis

Background: Autosomal dominant hyper-IgE syndrome (HIES), also called Job syndrome, is a genetic disorder that affects the immune system. It can cause skin and lung infections and problems with blood vessels, connective tissues, and bones. People with HIES often have lupus-like disease or atopic dermatitis (skin rash). Researchers want to know if a drug approved to treat other immune system diseases (baricitinib) can help people with HIES. Objective: To test baricitinib in people with HIES with lupus-like disease or skin rash. Eligibility: People aged 12 years and older with HIES with lupus-like disease or skin rash. Design: Participants will have 5 clinic visits, 4 remote visits, and 2 phone visits in 9 months. Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of the speed and pressure of blood flow through their body: Blood pressure cuffs will be placed on each arm and leg; electrodes will be placed on the wrists and a microphone on the chest. The study has a 3-month lead-in period. Participants will not take the study drug during this time. They will continue with their usual medical care. They will have 2 phone calls with the study team. Baricitinib is a tablet taken by mouth. Participants will take 1 or 2 tablets by mouth every day for 6 months. They will start with a low dose and may increase to a higher dose. Blood and urine tests will be repeated during each study visit. Other tests may also be repeated during some visits. A skin sample may also be taken....

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema. Healthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40 years of age may be eligible for this study. We also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to AD. Eligible participants undergo the following tests and procedures: * Medical family and medication history * Skin examination * Blood tests (research blood as well as serum IgE, and complete blood count) * Skin samples to analyze microbes. Samples are obtained by the following methods: swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal) of a small skin sample less than 1/4-inch (5 mm) in diameter. * Nose swabs to analyze microbes. * Patients with eczema may have photographs of their skin taken to help monitor the skin rashes. Participants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and during all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible. ...

This study will test a study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans. The study is looking at: * What side effects REGN20423 might cause * How much REGN20423 is in the blood at different times * How well REGN20423 works in adults with atopic dermatitis * Whether the body makes antibodies against REGN20423 * How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others * What the best dose of REGN20423 is

This study will assess long-term safety and efficacy of Afimkibart (also known as RO7790121) in participants with Atopic Dermatitis (AD) who participated in previous afimkibart clinical trials.

The purpose of this study is to find out how well tilrekimig works, how safe it is, and how it affects the body in adults and adolescents with moderate to severe atopic dermatitis (eczema). Eczema is a condition which can cause dryness, itching, and redness of your skin. The study is seeking participants who: * Are aged 12 years or older. * Were confirmed to have atopic dermatitis (AD) at least 12 months ago. * Are not having an effective treatment result from medicines that are applied on skin for AD. * Are considered by their doctors to have moderate to severe AD. The study treatment period will be 52 weeks. During the 24-week initial treatment period, participants will be randomized to one of three study treatments - tilrekimig, dupilumab, or placebo. Placebo does not have any medicine in it but looks just like the medicine being studied. These treatments will be randomized based on a 2:2:1 ratio. This means out of 1375 participants, about 550 participants will receive tilrekimig, 550 will receive dupilumab, and 275 will receive placebo. This will be followed by a 28-week maintenance period. The last dose of study treatment will be administered at week 48. Some participants will join the long-term extension (LTE) study C4531008 at week 52. A long-term extension study is an additional study that some participants may be able to join after completing the study if they are interested and meet eligibility requirements. It allows researchers to continue collecting information about how well the study medicine works. It also helps them assess how safe it is when used for a longer period of time. Participants who do not join this study will enter a 12-week safety follow-up period. This period ends 16 weeks after their last dose of study treatment.

Background: \- About 15 million Americans have a food allergy. Because there are no cures or effective prevention or treatment for food allergies, researchers want to learn more about them. Objective: \- To learn more about the causes and effects of food allergy and related conditions. Eligibility: * People ages 2 99 who have food allergy and/or a related genetic or other condition * Their relatives * Healthy relatives and volunteers Design: * Participants will have at least 3 visits over 1 2 years, and then once a year for up to 12 years. Each may last a day or longer. * Participants will be screened with medical history, physical exam, and questionnaires. * Participants may have the following: * Blood tests * Allergy skin prick tests: Drops of allergens are placed on the back or arm. The skin is scratched under each drop. * Leukapheresis: blood is taken from a needle in one arm, passed through a machine, and returned through a needle in the other arm. * X-rays * Esophageal string test: One end of a string is taped to the cheek and the other end is packed into a capsule. When the capsule is swallowed, the string unwinds; it is left in for at least 1 hour. * EGD and colonoscopy: Biopsies are taken from the gastrointestinal system. * Tiny biopsies of skin * Photographs of the body * Collection of cells through: * Swab of nose, inside of cheek, or skin * Gentle skin scrape * Tape stripping: piece of tape is put on the skin and pulled off.

The goal of this clinical trial is to evaluate the safety and tolerability of QX-453, an investigational treatment, in healthy Chinese volunteers and patients with moderate-to-severe atopic dermatitis. The study will assess how the drug is absorbed and processed by the body, and check for any side effects. Participants will receive single or repeated oral doses of QX-453 under close medical supervision, with regular safety and clinical assessments throughout the trial.

Atopic dermatitis (AD), also known as eczema, is a common chronic inflammatory skin disease that usually begins in infancy and causes significant itching, discomfort, and sleep disturbance. It affects up to one in five children worldwide and represents a growing public-health problem. Research has shown that genetic and environmental factors contribute to its development, especially those related to skin-barrier integrity and the skin microbiome during early life. Preventing AD before it starts-known as primary prevention-has become an important goal. Vernix caseosa is a naturally occurring, white, creamy substance that covers the skin of newborns at birth. It forms during the last trimester of pregnancy and plays a key role in protecting and hydrating the baby's skin before and after birth. Vernix contains water, lipids, and proteins with antimicrobial and anti-inflammatory properties. Despite these potential benefits, in many hospitals vernix is routinely removed soon after delivery as part of standard newborn cleaning or bathing practices. However, there is little scientific evidence to support early removal, and some studies suggest that keeping vernix on the skin for longer may help the newborn's skin barrier function and reduce colonization by harmful bacteria. The PROTEGO Study (Post-Partum Retention of Vernix Caseosa for Primary Prevention of Atopic Dermatitis, Guarding Skin Integrity and Fostering a Healthy Microbiome) is a randomized controlled clinical trial designed to test whether delaying the removal of vernix caseosa after birth can help prevent atopic dermatitis and improve skin health during the first year of life. A total of 1,383 mother-infant pairs will be enrolled from three maternity hospitals in Santiago, Chile. Participants will be randomly assigned to one of two groups: 1. Retention group: Vernix caseosa will be left on the skin and allowed to dry naturally; the baby's first bath will be delayed according to the study protocol. 2. Removal group: Vernix will be removed following current hospital practice using gentle cleaning with water and oil or petroleum jelly shortly after birth. All infants will be followed for 12 months with regular clinical assessments, standardized skin evaluations, and collection of biological samples. The main outcome will be the cumulative incidence of atopic dermatitis, diagnosed using modified UK Working Party criteria and/or Hanifin \& Rajka criteria at 12 months of age. Secondary outcomes include skin-barrier measurements (transepidermal water loss, skin pH, and natural moisturizing factor), the composition of the skin microbiome, and early signs of allergic or infectious diseases. This study will provide high-quality evidence on whether preserving vernix caseosa after birth is a simple, safe, cost-effective and natural strategy to strengthen the newborn's skin barrier and reduce the risk of eczema and related conditions. The results could help improve newborn-care practices and promote skin health in early life worldwide.

The goal of this Phase 4 clinical study is to learn how Ebglyss (lebrikizumab) works and how it is dosed in everyday dermatology care for adults and adolescents (age 12 and older) with moderate-to-severe atopic dermatitis (eczema). Ebglyss is approved by the U.S. Food and Drug Administration, and its label allows maintenance injections every 2 weeks, every 4 weeks, or every 8 weeks. It is not yet known how doctors and patients choose among these options in real-world practice. The study is for patients whose doctor has already decided, as part of their regular care, to start Ebglyss. The study is offered only after that decision is made. The main questions this study aims to answer are: How many participants have clear or almost clear skin, and how many have their itch under control, 24 weeks after starting Ebglyss? What portion of participants are on each dosing schedule (every 2, 4, or 8 weeks) at the end of the 56-week study, and how long do they stay on it? Why do doctors and patients keep or change the dosing schedule over time? All participants receive open-label Ebglyss, used within its FDA-approved label. There is no placebo or comparison group. After the first 16 weeks of standard dosing, the study doctor chooses the dosing schedule with the participant's input, following the label and the study's treatment rules, and records the reason for each decision. Participants will: * Receive Ebglyss, provided at no cost during the study * Attend 8 clinic visits over 56 weeks (about 13 months) * Answer questionnaires at visits about itch, sleep, skin symptoms, and quality of life * Complete a short online survey each month from home

This first-in-human study evaluates BYN-001, a humanized IgG1 monoclonal antibody targeting interleukin-25 (IL-25), a cytokine implicated in atopic dermatitis. Parts A and B are randomized, double-blind, placebo-controlled single and multiple ascending dose cohorts in healthy adults, that will assess safety, tolerability, pharmacokinetics, pharmacodynamics and immunogenicity of BYN-001. Part C will assess BYN-001 in adults with moderate to severe atopic dermatitis.

This is a Phase 1, randomized, blinded, placebo controlled, single-ascending dose (SAD) and multiple-ascending dose (MAD) study of BBT001 in healthy volunteers (HVs) and adult patients with moderate to severe Atopic Dermatitis (AD).

The objectives of this prospective non-interventional study are to characterize the existing unmet needs across the spectrum of atopic dermatitis (AD), enhance the understanding of the patient journey, and evaluate the safety and clinical outcomes of systemic AD treatments in a real-world setting. Additionally, patient-specific factors (such as age, skin color, AD flare triggers, previous treatment responses, comorbid conditions, and the extent and site of lesions) will be assessed to better characterize the impact on the treatment journey across a broad age range and diverse geographic regions. The study will be conducted across 10 countries in 4 different geographical regions, with a follow-up period of 5 years.

This trial is designed to evaluate multiple compounds in participants with moderate to severe atopic dermatitis (AD).

The purpose of this study is to learn if the study medicine (PF-08049820) is safe and effective for the treatment of atopic dermatitis (AD), also known as eczema, or atopic eczema. People with this condition may have severe itching and rashes on the skin. The study is seeking participants who: 1. Are 18 to 64 years of age; 2. Were confirmed to have AD at least 6 months ago; 3. Do not have a suitable prescribed medicine for AD; 4. Are considered by their doctors to have moderate to severe AD. The study has two stages (Stage 1 and Stage 2). In both stages, eligible participants will take either PF-08049820 or placebo as tablets by mouth daily for 12 weeks. A placebo does not have any medicine in it but looks just like the medicine being studied. Participants will visit the clinic on Day 1, Weeks 1, 2, 4, 6, 8 and 12. They will have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. They will have blood and urine tests. They will also have to answer questions about their health, skin condition, and how much their skin condition affects their lives. The experiences of participants receiving the study medicine will be compared to those receiving placebo. This will help to understand if PF-08049820 is safe and effective.

This 24-month study will assess the long-term safety and efficacy of liquid abrocitinib oral suspension with or without topical medications in children 2 years of age or older with moderate-to-severe atopic dermatitis. The study will enroll two groups: participants who have completed other abrocitinib studies and participants who have never participated in abrocitinib studies.

This prospective, multicenter study aims to evaluate whether patients with moderate-to-severe atopic dermatitis who achieve optimal disease control during treatment with abrocitinib 200 mg once daily can maintain disease control following dose reduction to 100 mg once daily. Adult patients who have achieved Minimal Disease Activity (MDA) at two consecutive visits at least one month apart will undergo abrocitinib dose tapering from 200 mg/day to 100 mg/day. Patients will be evaluated at Weeks 4, 16, and 32 after dose reduction. The primary objective is to determine the proportion of patients maintaining MDA following dose tapering and to explore clinical factors associated with successful maintenance of disease control. Additional outcomes include changes in disease severity, itch, sleep disturbance, quality of life, treatment adherence, involvement of difficult-to-treat anatomical areas, use of topical therapies, and treatment safety and tolerability.

This is a multicenter, double-blind, Long-Term Extension (LTE) study to evaluate the long-term safety and efficacy of APG777 in patients with moderate-to-severe AD who have completed treatment in an APG777 Parent Study (NCT06395948). The LTE study will consist of 3 periods: 1) Screening Visit will coincide with the last visit of the Maintenance Period in the Parent Study 2) Extended Treatment Period 3) Post-treatment Follow-up Period. This study will be conducted in participants with atopic dermatitis (AD) who completed the Treatment Period in a prior APG777 study and who, in the opinion of the Investigator, would benefit from long-term treatment with APG777.

Atopic dermatitis is a chronic inflammatory skin disease that is commonly associated with itching, sleep disturbance, and impaired quality of life. Melatonin may have beneficial effects on sleep, inflammation, and oxidative stress. This randomized controlled trial will evaluate the effectiveness of oral melatonin as an adjunct to standard treatment in adults with atopic dermatitis. A total of 130 participants will be randomly assigned in a 1:1 ratio to receive either standard treatment according to the Vietnamese Ministry of Health 2023 guideline or standard treatment plus oral melatonin 6 mg once daily for 4 weeks. Atopic dermatitis severity will be assessed using the SCORing Atopic Dermatitis (SCORAD) index, and sleep quality will be evaluated using the Pittsburgh Sleep Quality Index (PSQI). Serum superoxide dismutase and melatonin concentrations will also be measured to assess changes related to oxidative stress and melatonin status. Participants will be evaluated at baseline and during the 4-week treatment period.

Background: The immune system is the part of the body that fights infection. Some people have immune deficiencies that cause skin rashes, make them get sick often with infections, or make it difficult for their skin to heal. Researchers want to learn more to better treat conditions that affect immune response. Objective: To learn about how the immune system and skin healing are related to each other. Eligibility: People ages 18-75 with primary immune deficiency, eczema, or psoriasis. Healthy volunteers are also needed. Design: Participants will be screened with a medical and medicine history and a physical exam. They may take a pregnancy test. Participants will discuss the medicines or supplements they take as well as skin products they use, such as soaps and lotions. Participants will have up to 4 skin biopsies taken from the forearm. A needle will inject an anesthetic into the skin where the biopsy will be done. A sharp tool that looks like a tiny cookie cutter will be used to remove a round plug of skin a bit smaller than the tip of a pencil. Participants will give at least 1 blood sample. Participants may have optional skin swab collection. A cotton swab will be used to swab the skin on the arm. Participants may have optional skin tape collection. A sticky strip of tape will be placed on the arm and then removed. Participants may give leftover samples taken as part of their regular medical care. Participation will last for about 4 days. Participants will have 2 visits that each last about 1 hour. They may be asked to repeat the study in the future.

This clinical study is designed to test how well a medicine called abrocitinib works and how safe it is for young children (ages 2 to under 6) who have moderate-to-severe eczema (also known as atopic dermatitis).Eczema is a skin condition that can cause the skin to be dry, itchy, have scaly patches, blisters and skin infections. How the study works: * Children will be randomly placed into two groups: * 2 out of 3 will get the real medicine (abrocitinib). * 1 out of 3 will get a placebo (a look-alike liquid with no active medicine). * Neither the families nor the doctors will know which group each child is in (this is called double-blind). This study is seeking for children: * between 2 and under 6 years old. * Who have had eczema for at least 1 year. * Who have moderate-to-severe eczema at the start of the study, based on skin area affected and symptom scores. The medicine is given once a day as a liquid. The amount given depends on the child's body weight. If the child's eczema doesn't improve enough between weeks 4 and 8, the dose might be increased (still without anyone knowing which group they're in), unless the child can't tolerate it. All children will also use standard medicated creams during the study. The study will be up to 24 weeks long and there will be a screening period (up to 28 days) to make sure each child qualifies for the study.

This study will collect skin measurements from people with atopic dermatitis (AD) using the investigational Nevisense Go device. Participants aged 12 to 89 years with a history of AD flares will use the device at home for about 90 days. Participants will complete device measurements, electronic diary entries, and up to five in-person study visits. The study is based on the idea that changes in skin barrier function may occur before an AD flare becomes visible or symptoms begin. Information collected during the study, including device measurements, diary entries, and investigator assessments, will be used to evaluate whether these changes may help estimate the likelihood of an AD flare before visible signs or symptoms occur.

TARGET-DERM+ is an observational research study to conduct a comprehensive review of outcomes for patients with dermatologic disease (DD) and providers who treat these patients. The study includes patients managed for DD of any etiology in usual clinical practice in the United States and addresses important clinical questions regarding the management of DD by collecting and analyzing data from patients at academic medical centers and community medical practices and/or data from providers who treat them.

The goal of this clinical trial is to evaluate the feasibility of low-sodium diet to improve eczema severity. The main questions it aims to answer are: * Does a low-sodium diet improve eczema severity? * How does a low-sodium diet impact skin sodium concentration? * Is skin sodium concentration associated with eczema severity? Researchers will ask all participant to follow a low-sodium diet, then compare sodium tablets to a placebo (a look-alike substance that contains no drug) to specifically examine the impact of altering sodium intake. Participants will: * Follow a low-salt diet for the duration of the 24-week study * Take sodium chloride tablets every day for 5 weeks followed by a placebo every day for 5 weeks after a 2-week washout period, or vice versa * Complete up to 4 virtual check-in visits * Visit the clinic 4 times to answer questionnaires, provide bio samples, complete dietary recalls, and undergo non-contrast sodium MRI

The therapeutic cornerstone for mild to moderate forms of atopic dermatitis (AD) relies on the combination of topical corticosteroids and emollients. However, the daily application of emollients can be burdensome, leading to poor adherence, treatment fatigue, and therapeutic failure, often prompting a switch in emollient products. Emollients therefore represent a true therapeutic challenge. They also raise economic concerns, as they are not reimbursed by national health insurance, unlike topical corticosteroids. This results in an out-of-pocket expense for patients, adding a significant financial burden in the context of this chronic skin condition. Laboratoires Gilbert have developed and patented an active ingredient derived from seawater (Active Oligo Skin), formulated and produced at their pharmaceutical site in Hérouville Saint Clair. This active compound has shown promising in vitro and preclinical results in modulating inflammatory mechanisms involved in sensitive and atopic skin. The objective of this clinical trial is to compare the efficacy of Laboratoires Gilbert's patented emollient balm (Relipid+) with a reference emollient balm considered the "gold standard" and most frequently prescribed on the market (Lipikar Baume AP+M, La Roche-Posay) for atopic dermatitis. The hypothesis is that the test balm will be at least as effective as the gold standard (non-inferiority) in clinical terms, with an added benefit on microbiome diversity-an emerging and critical issue in the management of atopic dermatitis.

Atopic dermatitis is a common multifactorial skin disease. Topicals are the mainstay of treatment, but adherence to topicals is often abysmal, possibly worsened by the complexity of recommended treatment algorithms. Giving patients a simple, one drug approach may be advantageous.