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Dermatitis, Atopic clinical trials

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NCT ID: NCT05502848 Not yet recruiting - Atopic Dermatitis Clinical Trials

The Effect of Intervention and Mechanism of ICBT on Chronic Itching in Patients With Atopic Dermatitis

Start date: August 20, 2022
Phase: N/A
Study type: Interventional

Objectives: The study subjects were 180 healthy people from the dermatology clinic of Xiangya Hospital of Central South University and the surroundingcommunity, including 120 AD patients (60 in the ICBT treatment group and 60 in the control group) and 60 healthy controls. Methodology: After obtaining the informed consent of the subjects, the general condition and clinical symptoms of the subjects were assessed, the cognitive and psychological characteristics of the subjects who met the inclusion were assessed, multimodality MRI was scanned and blood and saliva samples were collected. The same assessments and data collection were performed with healthy controls matched for age, sex, and years of education in the AD patient group. AD patients were randomly assigned to the ICBT intervention group (n = 60) by a random number table and immediately started ICBT adjuvant therapy, or the control group (n = 60) for conventional therapy. Clinical symptoms and cognitive psychological characteristics of AD patients were assessed at the end of 2 weeks, 4 weeks, 8 weeks, 6 months and 12 months of ICBT treatment, and cognitive behavioral task measurements, multimodality magnetic resonance scans, blood and saliva samples will be performed again at the follow-up time point at the end of 6 months. Healthy controls (60) will also undergo a full set of follow-up assessments again after 6 months.

NCT ID: NCT05502185 Not yet recruiting - Atopic Dermatitis Clinical Trials

Targeting Staphylococci in Atopic Dermatitis

Start date: September 1, 2022
Phase:
Study type: Observational

The aim of the study is to deliver a better understanding of the molecular mechanisms used by S. epidermidis strains in their adhesion and colonization on the stratum corneum across a broad spectrum of atopic dermatitis in mild to moderate conditions in adult patients.

NCT ID: NCT05500794 Recruiting - Psoriasis Clinical Trials

Meditation in Inflammatory Dermatosis

MediDermIn
Start date: November 15, 2022
Phase: N/A
Study type: Interventional

Psoriasis and atopic dermatitis are multifactorial inflammatory dermatoses, with a very high prevalence, reaching more than 120 million patients in the world. Although the physiopathological mechanisms are not yet clearly defined, these inflammatory dermatoses involve an interaction between the immune system and the epidermal cells, severe skin inflammation and often very intense pruritus. The objectives of an effective management should be to treat lesions in order to reduce them, but also to reduce itching and allow the patients to accept and cope with their pathology, without neglecting an improvement in the "Dermatology Life Quality Index" (DLQI) and in the psychological state, sometimes depressive, of the patient. Itching is defined as "a feeling that needs to be scratched urgently" and can cause significant distress along with pain. It severely impacts the quality of life and the quality of sleep. Chronic itching is associated with increased stress, anxiety, and other mood disorders. In turn, stress and anxiety exacerbate the itching, leading to a vicious cycle of pruritus - scratching that affects patient behavior (excessive scratching) and worsens disease prognosis and quality of life. Much research over the past few decades has demonstrated the effect of mindfulness meditation on emotional and cognitive responsiveness, cognitive flexibility, rumination, self-compassion and mindfulness, but also on acute pain, anxiety, stress, depression, cardiovascular disease, eating disorders, cancer and cognitive loss with age. Several studies have shown the impact of mindfulness on brain function and immunity, with evidence for the association between mindfulness and changes in the levels of markers characteristic of immune system activity and inflammation, known to be increased in psoriasis or atopic dermatitis. The objective is to evaluate the effect of mental training in the regulation of stress and emotions through mindfulness meditation in patients with moderate, itchy atopic dermatitis or psoriasis, not treated with systemic agents (e.g.: biotherapies). This project is based on the premise that mental training in the regulation of stress and emotions through meditation would reduce the effects of the infernal itch-scratch cycle, alleviating pruritus, thus improving the well-being and mental health of patients while reducing their inflammatory skin lesions and limiting the appearance of new lesions.

NCT ID: NCT05492578 Recruiting - Dermatitis Atopic Clinical Trials

Long-Term Safety and Efficacy Evaluation of Amlitelimab in Participants of Previous Amlitelimab Moderate to Severe Atopic Dermatitis Clinical Trials

RIVER-AD
Start date: August 22, 2022
Phase: Phase 2
Study type: Interventional

This is a single group, Phase 2, long-term extension study for treatment. The purpose of this study is to characterize the safety and efficacy of amlitelimab in treated adult participants with moderate to severe AD who have previously been enrolled in an amlitelimab clinical trial. Visits during the on-treatment period will be at Week 0, 1, 2, 4 and every 4 weeks (Q4W) thereafter. If remote visits are considered appropriate for participants instead of clinic visits at the timepoints indicated in the schedule of activities (SoA) participants/caregivers/legally authorized representatives (LAR) are allowed to perform participant-injections at home according to the schedule of dosing. This decision is at the discretion of the investigator.

NCT ID: NCT05491447 Terminated - Atopic Dermatitis Clinical Trials

A Clinical Trial of BMX-010 in Adult Subjects With Atopic Dermatitis

Start date: January 8, 2023
Phase: Phase 2
Study type: Interventional

Phase 2 clinical trial conducted in 2 parts: Part 1 - Pharmacokinetics and Part 2 - Randomized and Placebo Controlled (subject and clinical assessors will be blinded). Study Product will be applied to AD BID days 1-28. There will be weekly visits from Baseline (day 1) through Day 29. There is a final follow up visit 2 weeks after.

NCT ID: NCT05487963 Not yet recruiting - Atopic Dermatitis Clinical Trials

Tolerability and Effectiveness of CGB-500 Topical Ointment, 1% Tofacitinib, for the Treatment of Atopic Dermatitis

Start date: September 15, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the proposed study is to evaluate the tolerability and effectiveness of a 1% topical ointment of tofacitinib for the treatment of mild to moderate atopic dermatitis in adults. Adult patients with a diagnosis of atopic dermatitis for at least 6 months will be treated with the test product or placebo for a period of 8 weeks with a follow-up visit at 12 weeks. The primary endpoints are safety and tolerability of CGB-500 Ointment and a comparison of effectiveness of CGB-500 Ointment and Vehicle Ointments in treating lesion(s) of mild to moderate atopic dermatitis.

NCT ID: NCT05486208 Terminated - Healthy Clinical Trials

A Study of LY3844583 in Healthy Participants and Participants With Atopic Dermatitis

Start date: August 11, 2022
Phase: Phase 1
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of LY3844583 in healthy participants and participants with atopic dermatitis. The study will also assess how fast LY3844583 gets into the blood stream and how long it takes the body to remove it. The study is open to healthy participants and participants with atopic dermatitis. The study will be conducted in three parts and each participant will enroll in one part. The study will last up to 88, 116, and 186 days with 10, 13, and 14 visits for each participant in parts A, B, and C, respectively.

NCT ID: NCT05470114 Completed - Atopic Dermatitis Clinical Trials

A Multi-omics Disease Signature Trial in Adult Patients With Moderate to Severe AD

Start date: May 19, 2022
Phase: Phase 2
Study type: Interventional

This clinical trial will investigate the effectiveness and safety of a new active ingredient (LEO 138559) in the treatment of moderate to severe atopic dermatitis (AD). It is given by subcutaneous injection. Some people in the trial will instead receive Dupixent® which is an approved treatment for moderate to severe AD. Dupixent® is also given by subcutaneous injection. The main aim of this clinical trial is to investigate which changes in biomarkers in the skin are caused by LEO 138559 and Dupixent®. The trial includes a screening phase of up to 4 weeks, followed by a treatment period of 16 weeks, and a safety follow-up period of 16 weeks.

NCT ID: NCT05469464 Active, not recruiting - Atopic Dermatitis Clinical Trials

Study to Assess the Efficacy and Safety of Orismilast in Atopic Dermatitis (ADESOS)

Start date: July 11, 2022
Phase: Phase 2
Study type: Interventional

This study investigates 3 different doses of orismilast modified release compared to placebo in adult patients with moderate-to-severe atopic dermatitis. The purpose of the study is to assess the effect of orismilast modified release in moderate-to-severe atopic dermatitis and assess the safety aspects of these 3 different doses. The patients will receive an oral treatment of either orismilast modified release tablets or placebo tablets 2 times a day for 16 weeks.

NCT ID: NCT05467046 Completed - Atopic Dermatitis Clinical Trials

Clinical Relevance of Scratching and Sleep in Atopic Dermatitis

Start date: August 3, 2022
Phase:
Study type: Observational

Atopic Dermatitis (AD), otherwise known as (atopic) eczema, is a chronic relapsing inflammatory skin disease. For difficult-to-treat AD, treatment options are limited. A better understanding of the underlying immunological cause, led to development of new, targeted therapies. For evaluating effectiveness and making treatment decisions for these new therapies, only 2 subjective methods exist: 1. clinical scores (AD-severity scored by a physician using structured scoring system), 2. questionnaires (completed by AD-patients). Therefore, an objective AD-severity assessment method might provide benefits for clinical practice. In this study, it is evaluated whether scratching and sleep parameters, obtained with a smartwatch worn by AD-patients, provide added value for clinical practice in dermatology. The usability of this smartwatch system is evaluated by AD-patients.