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Atopic Dermatitis clinical trials

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NCT ID: NCT06390722 Not yet recruiting - Atopic Dermatitis Clinical Trials

A Study to Assess the Effect of Upadacitinib in Atopic Dermatitis-induced Sleep Disturbance in Adults With Moderate to Severe Atopic Dermatitis

Sleep Up
Start date: May 23, 2024
Phase: Phase 3
Study type: Interventional

Many people with atopic dermatitis (AD) experience sleep disturbances. Greater sleep disturbances are associated with greater burden including increased sick days and impaired cognition. Patient focused research has found that sleep was one of the 3 most problematic symptoms for people with AD and their families. Upadacitinib demonstrated clinically meaningful sleep improvement based on patient-reported outcome measures such as the Atopic Dermatitis Impact Scale (ADerm-IS) Sleep Domain score in Phase 3 registrational trials, but objective data on upadacitinib's effect on elements of sleep disturbance such as Wake After Sleep Onset, or Sleep Efficiency, have not been collected. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 Periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib or Placebo. In Period 2, participants will be switched to receive open-label upadacitnib. Approximately 112 adult participants ages 25 to 63 with moderate to severe AD who have moderate to severe sleep disturbance will be enrolled at up to 32 sites worldwide. This study consists of a 35-day Screening Period; a 2-week randomized, double-blinded period (Period 1); a 22-week open-label extension period (Period 2); and a 30-day follow-up visit/call. Participants will receive oral tablets once per day of Upadacitinib or Placebo for 2 weeks followed by Upadacitinib oral tablet for 22 weeks There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT06389136 Not yet recruiting - Atopic Dermatitis Clinical Trials

A Study of Upadacitinib in Adult Participants With Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab

Switch-Up
Start date: May 24, 2024
Phase: Phase 3
Study type: Interventional

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. Therapies spread over the skin may not be enough to control the AD in trial participants who require systemic anti-inflammatory treatment. This study aims to provide data on the efficacy and safety of upadacitinib at different doses in adult participants with moderate to severe AD. Upadacitinib is an approved drug for the treatment of moderate to severe atopic dermatitis (AD). This study is conducted in 2 periods. During Period 1, participants are randomly assigned into 1 of 2 groups called treatment arms to receive upadacitinib Dose A or dupilumab Dose A. Based on the participants response to upadacitinib Dose A, they may have their dose increased to upadacitinib Dose B after 2 weeks. In Period 2, participants that completed Period 1 will either remain on their assigned dose or be reassigned to a different dose based on their Eczema Area and Severity Index (EASI) response. Approximately 300 adult participants ages 18 to 64 with moderate to severe AD who are current users of dupilumab and had a history of inadequate response to dupilumab will be enrolled at up to 94 sites worldwide. The study is comprised of a 35-day Screening Period, an 8-week Open-Label Period 1 and a 24-week Open-Label Period 2 for participants that completed Period 1. Participants will receive upadacitinib oral tablets once daily or dupilumab subcutaneous (SC) injection every other week for 32 weeks and followed for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

NCT ID: NCT06362629 Not yet recruiting - Atopic Dermatitis Clinical Trials

AI App for Management of Atopic Dermatitis

Start date: September 1, 2024
Phase: N/A
Study type: Interventional

Background: Atopic dermatitis (AD) is a chronic inflammatory skin disease characterized by recurrent rashes and itching, which seriously affects the quality of life of patients and brings heavy economic burden to society. The Treat to Target (T2T) strategy was proposed to guide optimal use of systemic therapies in patients with moderate to severe AD, and it is emphasized patients' adherence and combined evaluation from both health providers and patients. While effective treatments for AD are available, non-adherence of treatment is common in clinical practice due to the patients' unawareness of self-evaluation and lack of concern about the specific follow-up time points in clinics, which leads to the treatment failure and repeated relapse of AD. Hypothesis: An Artificial Intelligence assistant decision-making system (AIADMS) with implementation of the T2T framework could help control the disease progression and improve the clinical outcomes for AD. Overall objectives: We aim to develop an AIADMS in the form of smartphone app to integrate T2T approach for both clinicians and patients, and design clinical trials to verify the effectiveness and safety of the app. Methods: This project consists of three parts, AI training model for diagnosis and severity grading of AD based on deep learning, development of Artificial Intelligence assistant decision-making system (AIADMS) in the form of app, and design of a randomized controlled trial to verify the effectiveness and safety of AIADMS App for improvement of the clinical outcomes in AD patients. Expected results: With application of AIADMS based app, the goal of T2T for patients with AD could be realized better, the prognosis could be improved, and more satisfaction could be achieved for both patients and clinicians. Impact: This is the first AIADMS based app for AD management running through thediagnosis, patients' self-participation, medical follow-up, and evaluation of achievement of goal of T2T.

NCT ID: NCT06330974 Not yet recruiting - Asthma Clinical Trials

Allergy, Asthma, and Atopic Eczema in Finland

FinnATOPY
Start date: October 2024
Phase:
Study type: Observational [Patient Registry]

The summary is available at --> https://www.finnatopy.fi/summary

NCT ID: NCT06324695 Not yet recruiting - Psoriasis Clinical Trials

Development and EValuation of an Online Intervention to Reduce Self-Stigma in People With Visible Chronic Skin disEases

DEVISE
Start date: March 2024
Phase: N/A
Study type: Interventional

This project aims to develop and evaluate an online intervention to prevent and/or reduce self-stigma in German patients with visible chronic skin diseases. Evaluation of the intervention with regard to effectiveness and feasibility will follow an open-label randomized controlled design with 550 patients in total. The results of the program are expected to provide new insights and markedly extended knowledge on the mechanisms of self-stigma in chronic skin conditions. The new online intervention can be used in routine care, aiming for better patient care in practice and, ultimately decreased extent of self-stigma, increased quality of life of patients, and decreased rates of depression, anxiety, and suicide ideation.

NCT ID: NCT06311682 Not yet recruiting - Atopic Dermatitis Clinical Trials

A Trial to Evaluate the Efficacy and Safety of Tralokinumab in Combination With Topical Corticosteroids in Children and Infants With Moderate-to-severe Atopic Dermatitis

TRAPEDS 2
Start date: May 24, 2024
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to test whether treatment with tralokinumab (administered subcutaneous injections [SC]) in combination with topical corticosteroids (TCS) is safe and effective to treat moderate-to-severe atopic dermatitis (AD) in children and infants. This will be judged by a range of assessments that rate the severity and extent of atopic dermatitis and its symptoms, as well as general health status and quality of life. The trial will last for up to 4 years. There will be visits every 2 weeks for the first year and every 6 weeks thereafter. Some of the visits will be conducted by phone. The study involves two different age groups: children aged 2 to under 12 years and infants aged 6 months to under 2 years. This trial compares tralokinumab +TCS to placebo + TCS for children with moderate-to-severe AD and evaluates tralokinumab + TCS for infants with moderate-to-severe AD. Infants will not receive placebo. All subjects will go through a screening process, which is the first part of the trial and will last up to 4 weeks. During this period, it will be checked if the child or infant meets the criteria to participate in the trial. The children will be randomly assigned to receive tralokinumab + TCS or placebo + TCS for the initial 16 weeks, with the treatment being double-blinded. During the first 16 weeks, children will have a 2 out of 3 chance of getting tralokinumab and a 1 out of 3 chance of getting placebo. Thereafter, all subjects will receive tralokinumab + TCS. The infants will receive tralokinumab + TCS as open-label treatment for the entire treatment period, meaning that the participants will know they are receiving tralokinumab. After stopping treatment, all participants will enter a 4-week safety follow-up period.

NCT ID: NCT06309355 Not yet recruiting - Atopic Dermatitis Clinical Trials

Topical YR001 Ointment in Adult With Mild to Moderate Atopic Dermatitis

Start date: June 2024
Phase: Phase 2
Study type: Interventional

This study is to evaluate the safety, tolerability, and pharmacokinetics of YR001 topical ointment in adult patients with mild to moderate atopic dermatitis

NCT ID: NCT06280716 Not yet recruiting - Atopic Dermatitis Clinical Trials

A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic Dermatitis

Start date: May 6, 2024
Phase: Phase 3
Study type: Interventional

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab with/without Topical Corticosteroid Treatment in Participants with Moderate-to-Severe Atopic Dermatitis. The study will last approximately 62 weeks.

NCT ID: NCT06277765 Not yet recruiting - Atopic Dermatitis Clinical Trials

Study of CM310 Injection in Adolescent Subjects With Atopic Dermatis

Start date: May 30, 2024
Phase: Phase 3
Study type: Interventional

This is a multi-center, randomized, double blind, placebo-controlled phase 3 study to evaluate the efficacy, safety, PK, PD and immunogenicity of CM310 in children patients with moderate-to-severe atopic dermatitis.

NCT ID: NCT06244212 Not yet recruiting - Atopic Dermatitis Clinical Trials

Topical Treatment for Atopic Dermatitis

Start date: April 2024
Phase: N/A
Study type: Interventional

Medication adherence is a poorly studied phenomenon that challenges both patients and physicians. 50% of individuals with chronic disease are not adherent to their medication regimen. Within the United States, non-adherence to medical treatment leads to approximately $100 billion in hospital admission costs. While the issue of adherence is not limited to any particular field of medicine, non-adherence occurs in approximately one-third to one-half of dermatological patients. Non-adherence is of importance as it is a significant cause of treatment failure, resulting in worse quality of life, worse health outcomes, and increased insurance costs.