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Showing 1-20 of 172 trials
NCT07355075
This is a Phase 2, randomized, double-blind, vehicle-controlled clinical study evaluating the efficacy and safety of GX-03 topical ointment in adult subjects with moderate to severe atopic dermatitis (eczema). The study plans to enroll up to 120 eligible patients with a target of at least 100 completing the study and an ability to expand enrollment up to 200 subjects based on a pre-specified interim assessment conducted by an Independent Data Monitoring Committee (IDMC). Subjects will be randomized in a 1:1 ratio to receive either GX-03 or vehicle control for 8 weeks. The study is designed to evaluate improvement in investigator-assessed disease severity, itch, and patient-reported eczema symptoms following topical treatment with GX-03 compared with vehicle control. Efficacy assessments include the Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™), Eczema Area and Severity Index (EASI), Peak Pruritus Numeric Rating Scale (PP-NRS), and Patient-Oriented Eczema Measure (POEM). An interim assessment of conditional power for the primary efficacy endpoint will occur after the first 50 subjects complete the Week 8 visit or withdraw prematurely. Based on pre-specified criteria defined in the IDMC Charter, the IDMC may recommend continuation as planned, expansion of enrollment up to 200 subjects, or early curtailment of enrollment.
NCT05735483
The main purpose of this study is to assess the long-term safety and efficacy of lebrikizumab in participants 6 Months to \<18 years of age with moderate-to-severe atopic dermatitis. This study will last about 68 weeks and may include up to 16 planned visits. If participating in the optional extension as well, the study will last approximately 1 additional year for a total of up to 116 weeks and may include up to 29 scheduled visits.
NCT01631617
Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin. Objectives: \- To study the effect of eczema treatments on skin bacteria. Eligibility: * Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis. * Healthy volunteers between 18 and 40 years of age with no history of eczema. Design: * Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed. * All participants will be assigned to one of several study groups. * Healthy volunteers must not have taken antibiotics in the year before the start of the study. * All participants will have regular study visits during their 1-year participation. More research samples will be collected at these visits. * Healthy volunteers may be asked to come in for a one-time follow up after the 1 year mark.
NCT06464133
The study, Investigation of Filaggrin Gene Mutations among Latinx patients with Atopic Dermatitis, will examine the association between pathogenic FLG LOF variants and AD in a new population of Latinx patients for which clinical and disease characteristics will be well-described.
NCT06474728
The goal of this study is to investigate whether the use of emollients containing postbiotic Saccharomyces and Lactobacillus can significantly reduce the risk of atopic dermatitis (AD) recurrence in pediatric patients aged 0-6 years during the remission phase, compared to the routine maintenance treatment with conventional emollients.
NCT07481019
The goal of this clinical trial is to evaluate whether an electronic patient-reported outcome measure (ePROM)-guided flexible scheduling system can improve outpatient clinic resource utilisation in patients attending dermatology outpatient clinics for routine follow-up. The main questions it aims to answer are: * Does the intervention reduce the number of actualised outpatient visits over 12 months compared with standard fixed scheduling? * Does the intervention group achieve higher adherence to monthly ePROM monitoring, as measured by the proportion of completed ePROM submissions?
NCT07463079
To investigate the safety and efficacy of the moisturizing lotion in improving eczema symptoms among individuals with atopic eczema in Malaysia. The study duration is 4 weeks and the skin assessment will be carried out at baseline and week 4. The main questions this study aims to answer are: 1. To investigate the safety of the moisturizing lotion for individuals with atopic eczema in Malaysia. 2. To determine the efficacy of the moisturizing lotion in improving eczema lesions among individuals with atopic eczema in Malaysia. 3. To assess the participants' satisfaction after using the moisturizing lotion.
NCT07438509
This randomized controlled trial (RCT) aims to evaluate the efficacy and safety of Crisaborole 2% cream compared with placebo in patients with mild to moderate atopic dermatitis (AD), also known as atopic eczema. AD is a chronic inflammatory skin condition characterized by itching, redness, and recurrent flares that can significantly impair quality of life. Eligible participants aged 12 to 50 years with mild to moderate AD will be randomly assigned to receive either Crisaborole 2% cream or a placebo cream applied twice daily for four weeks. The primary outcome is treatment success at Day 28, defined using the Investigator's Static Global Assessment (ISGA) as a score of 0 (clear) or 1 (almost clear) with at least a two-grade improvement from baseline. Participants will be evaluated at baseline, Day 14, and Day 28. Safety, tolerability, and compliance will also be assessed. The results of this RCT may provide locally relevant evidence to guide the management of mild to moderate AD.
NCT07216027
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 years of age or more; 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. 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, and have a follow-up visit at Week 16. During this time, the participant's health and skin condition will be checked. Participants will have blood and urine tests and must 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 participants receiving placebo. This will help to understand if PF-08049820 is safe and effective.
NCT07228962
This project aims to establish whether an adapted extraction device is tolerable and will be able to measure chemical signals in baby's ISF. Insight into the chemical profiles found in the skin interstitial fluid (ISF) of healthy and diseased babies will identify signals that can be used to investigate the causes of eczema and propose new preventative strategies and effective treatments. Specifically, it aims to: 1. Demonstrate that the developed ISF device can be used to extract biomarkers from the skin of babies non-invasively and is tolerable (not causing significant discomfort, bruising, or blister formation). 2. Compare the profile of chemical markers present in the ISF of healthy babies with babies that have developed eczema. 3. Compare the biomarker levels extracted from babies with eczema in lesional and non-lesional skin using the developed ISF device. 4. Compare the microbiome and metabolome profiles from swabs taken from babies with healthy skin and with eczema in lesional and non-lesional skin (exploratory outcome).
NCT04133506
Objectives: Eczema is a chronic inflammatory skin condition characterised immunologically by T cellmediated inflammation. The pathogenic mechanisms involved in its development are incompletely understood and targeted treatment options are limited. The investigators will study the Prostaglandin E2 (PGE2)/IL22/IL17 pathway which plays an important role in murine model chronic skin inflammation. The investigators wish to identify subtypes of human eczema in which this pathway may be involved and to determine whether manipulation of this pathway may offer effective new treatments. Design, tissue/cells, techniques and measurements: To address these objectives, the investigators will measure the expression of IL22, IL17A and PGE2 synthases and receptors in skin biopsies from eczema and psoriasis patients using immunohistochemistry (confirming this with RT-PCR). IL22/IL17 producing Tcells (from peripheral blood) and their skin-homing capability (by ex-vivo cell culture and flow cytometry) will be measured. Deriving immune cells from skin biopsies using Villanova's technique1, the investigators will determine the T-cell response to PGE2 looking at PGE2 receptors and cytokine expression, interrogating these cells by flow cytometry. To determine the sequence and kinetics of activation of the PGE2/IL22/IL17 pathway the investigators will measure each immune mediator at specific time points by recruiting healthy volunteers inducing irritant and allergic contact dermatitis using dithranol and DNCB respectively. The investigators will repeat the experiment dividing volunteers into two arms, one pre-treated for one week with a non-specific prostaglandin inhibitor (aspirin) and the second with a placebo control.
NCT06283550
This study aims to evaluate the safety, efficacy and tolerability of abrocitinib in subjects with moderate to severe chronic hand eczema, and its effects on skin biomarkers using a noninvasive method of tape stripping.
NCT05704205
The goal of this randomized controlled trial is to study the (cost)effectiveness of NB-UVB phototherapy in patients with atopic eczema/atopic dermatitis. Half of the participants will undergo a course of NB-UVB phototherapy of 8-16 weeks and apply optimal topical therapy (OTT) for a minimum of 3 months. Researchers will compare the outcomes of this group with the other half of participants that apply OTT only.
NCT06096857
Background: Atopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD. Objective: To test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD. Eligibility: People aged 2 years and older with AD. Design: All study visits will be remote. Participants will have 5 visits over about 7 months. Participants will be screened. Researchers will review their AD and medical history. Participants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks. Half of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have. During 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers. Participants may opt to have pictures taken of their AD. Participants will fill out 4 online questionnaires.
NCT07338305
Handeczema is a common chronic skin disease that markedly affect health and quality of life. Effective treatment is limited by the lack of biomarkers that can predict disease course, comorbidities and treatment response. This study is is an observational, prospective, study of patients initiating treatment with methotrexat at the Department of Dermatology and Allergy at Herlev- and Gentofte Hospital. The main aim is to study the clinical effect of methotrexat in patients with hand eczema. Secondary aims are to study drug survival, reasons for termination of treatment and side effects.
NCT05958407
The purpose of this study is to test if treatment with tralokinumab is safe and effectful to treat moderate-to-severe atopic hand eczema. This will be judged by a range of assessments that rate the severity and extent of atopic hand eczema and its symptoms, as well as general health status and quality of life. The trial will last for up to 40 weeks. There will be up to 15 visits, 3 of which will be conducted by phone. The first part of the trial is called a screening period and will last up to 4 weeks. For the first 16 weeks after screening, trial participants will receive either tralokinumab or dummy injections every two weeks. After the first 16 weeks, all trial participants will receive tralokinumab injections every two weeks for 16 weeks. The last part of the trial is a period of 4 weeks after the end of treatment period, where trial participants are off the drug for safety follow-up.
NCT05590585
The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked. From the previous studies on the study drug, it is seen that the study drug has an acceptable safety and effectiveness in participants with atopic dermatitis. The aim of this study is to get additional information on the safety and effectiveness of the study drug, particularly the information on aspects of atopic dermatitis in skin of color participants. The study is looking at several other research questions, including: * What side effects may happen from taking the study drug * How much study drug is in your blood at different times * How much the study drug improves quality of life and mental health
NCT05689151
The purpose of this study is to learn about the safety and effects of Abrocitinib in the real-life clinical setting given for the treatment of moderate to severe atopic dermatitis. Atopic dermatitis, or AD, is a long-lasting disease that causes inflammation, redness, and irritation of the skin. This study is seeking participant who are older than 18 years with moderate-to-severe chronic AD. Participants must have no underlying medical conditions that prevent them from taking Abrocitinib. All participants in this study will receive Abrocitinib as a tablet once daily. They can take Abrocitinib and use medicated topical treatment for AD at the same time. We will examine the experiences of patients receiving the study medicine. This will help us determine if the study medicine is safe and helps in treating AD. Participants will take part in this study for 24 months. During this time, they will visit the study clinic about 5 times (about 1 time every 4 to 6 months).
NCT06723405
This is a Phase 2a efficacy and safety study of EVO301 for the treatment of adults with atopic dermatitis.
NCT06004986
The goal of this randomized controlled trial is to study the (cost)effectiveness of extending the intervals between dupilumab doses in patients with well-controlled atopic eczema, while considering physician- and patient-reported disease severity, quality of life, and dupilumab serum trough levels. Patients will be divided randomly into three groups, receiving dupilumab 300 mg every 2 weeks, every 3 weeks, or every 4 weeks. Researchers will then compare the outcomes among these three groups.