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Dermatitis, Atopic clinical trials

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NCT ID: NCT05669794 Recruiting - Atopic Dermatitis Clinical Trials

An Observational Study to Assess Change in Disease Activity and Use of Upadacitinib Tablets in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis in Real World

UPDATE
Start date: February 21, 2023
Phase:
Study type: Observational

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. This study will assess how effective upadacitinib is in treating AD. Upadacitinib is an approved drug for treating AD. Approximately 300 adolescent and adult participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in France. Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed up for approximately 24 months per participant and 30 days after last treatment dose for safety data collection. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.

NCT ID: NCT05667623 Recruiting - Clinical trials for Atopic Dermatitis (AD)

To Demonstrate the Superiority of IMP (1% OPA-15406 Ointment) to the Vehicle in Adult Patients With AD

Start date: February 6, 2023
Phase: Phase 3
Study type: Interventional

This is a multinational (China and Korea), multicenter, randomized, double-blind, vehicle-controlled, parallel-group, comparison trial to demonstrate the superiority of 1% OPA-15406 ointment to the vehicle in adult AD subjects.

NCT ID: NCT05662800 Recruiting - Atopic Dermatitis Clinical Trials

Development of Peanut, Sesame, and Tree Nut Allergy in Polish Children at High Risk of Food Allergy

Start date: April 17, 2023
Phase:
Study type: Observational

The aim of the study is to assess the prevalence of peanut, tree nuts, and sesame allergy in Polish children at high risk of food allergy. Additionally, the timing of the development of peanut, tree nuts and sesame allergy in the first three years of life in a high-risk population will be assessed.

NCT ID: NCT05656911 Completed - Atopic Dermatitis Clinical Trials

A Study to Learn How Well the Study Treatment Zabedosertib (BAY1834845) Works and How Safe it is Compared to Placebo in Adult Participants With Moderate-to-severe Atopic Dermatitis

Damask
Start date: December 21, 2022
Phase: Phase 2
Study type: Interventional

Researchers are looking for a better way to treat atopic dermatitis (AD), an often long-lasting inflammation of the skin. Atopic dermatitis, also called eczema, is causing patches of skin to become swollen, red, cracked, and itchy. The immune system helps protect the body from diseases. But sometimes the immune system can be too sensitive and overreact. This may then lead to allergies but also to skin conditions like atopic dermatitis. The study treatment zabedosertib (BAY1834845) is currently under development for the treatment of atopic dermatitis and other inflammatory diseases. It works by reducing the activity of a protein called IRAK4. IRAK4 promotes the production and activation of a series of proteins that trigger inflammation reactions in the immune cells. By reducing the activity of IRAK4, the inflammation reactions are expected to be reduced. The main purpose of the study is to learn how well zabedosertib works compared to placebo. A placebo is a treatment that looks like a medicine but does not have any medicine in it. How well it works means to find out the efficacy of zabedosertib. To answer this, the researchers will compare how many participants had 75% EASI score reduction after 12 weeks treatment between participants treated with zabedosertib and those treated with placebo. EASI represents Eczema Area and Severity Index (EASI). It is a tool for measuring the amount and severity of atopic dermatitis that a patient has on his or her body. The score ranges from 0-72, with 0 meaning clear skin and 72 meaning severe atopic dermatitis. In addition, the itch of the study participants and other tools for measuring the severity of atopic dermatitis will be assessed. The secondary purpose of the study is to learn how safe it is compared to placebo. To know this, study team will compare how many participants having adverse events after taking study treatment between participants treated with zabedosertib and those treated with placebo. In the study, participants will be randomly (by chance) assigned to receive zabedosertib or placebo. The participants from both treatment groups will take zabedosertib or placebo for up to 12 weeks. The study consists of an up to 28-day screening period (Visits 1 and 2), a 12-week treatment period consisting of 5 visits (Visits 3 to 7), and a 4-week follow-up visits (Visits 8). Thus, the total study duration per participant will be 17 to 20 weeks (approximately 140 days). During the study, the study team will: - take blood and urine samples - take skin samples (not obligatory for all patients) - check the participants' disease area for assessment - provide participants device to record their disease status and to take pictures on their disease areas - have participants complete self-reported questionnaires - do physical examinations - examine heart health using ECG - check vital signs - ask the participants questions about how they are feeling and what events they are having. An adverse event is any problem that a participant has during a study. Doctors keep track of all adverse events that happen in studies, even if they do not think the adverse events might be related to the study treatments. At 28 days after the participants take their last treatment, the study team will check if participants have any events that might be related to the study treatment. This will be the last visit for the study.

NCT ID: NCT05651711 Active, not recruiting - Atopic Dermatitis Clinical Trials

A Study Assessing Rocatinlimab (AMG 451) Monotherapy in Moderate-to-severe Atopic Dermatitis (AD) (ROCKET-Horizon)

ROCKET-Horizon
Start date: December 14, 2022
Phase: Phase 3
Study type: Interventional

The co-primary objectives of the study are to: - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD). - Evaluate the efficacy of rocatinlimab compared with placebo at Week 24, assessed using Eczema Area and Severity Index (EASI).

NCT ID: NCT05650320 Recruiting - Clinical trials for Atopic Dermatitis (AD)

To Demonstrate the Superiority of IMP (0.3% and 1% OPA-15406 Ointment) Versus the Vehicle in Pediatric Patients With AD

Start date: February 17, 2023
Phase: Phase 3
Study type: Interventional

A multicenter, randomized, double-blind, vehicle-controlled, parallel group trial to demonstrate the superiority of 0.3% and 1% OPA-15406 ointment to vehicle in pediatric subjects with AD. This trial consists of the 0.3% OPA-15406 group, the 1% OPA-15406 group, and the vehicle group.

NCT ID: NCT05644691 Completed - Atopic Dermatitis Clinical Trials

Impact of the Daily Use of Emollient on Corticosteroids Consumption in Patients With Atopic Dermatitis

Start date: October 14, 2020
Phase:
Study type: Observational

This study aims at assessing the reduction of consumption of corticosteroids (same mid-potent corticosteroids for all patients) afforded by the use of a specific emollient in comparison to the usual one in subjects suffering from atopic dermatitis.

NCT ID: NCT05642208 Recruiting - Atopic Dermatitis Clinical Trials

Dupilumab Step-down Strategy to Maintain Remission in Adult and Adolescents Patients With Atopic Dermatitis

MADULO
Start date: March 8, 2023
Phase: Phase 4
Study type: Interventional

The goal of this clinical trial is to compare a step-down strategy of spacing dupilumab injections with a standard maintenance treatment in adolescents and adults with controlled Atopic dermatitis (AD) for at least six months. The impact of dosage reduction strategies will be assessed with an innovative primary endpoint: the area under the curve of the weekly ADCT assessment.

NCT ID: NCT05641558 Completed - Dermatitis, Atopic Clinical Trials

Evaluation of 611 in Chinese Adult Patients With Moderate-to-Severe Atopic Dermatitis

Start date: October 18, 2021
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the study was to evaluate the safety and tolerability of 611 in chinese adults with moderate to severe atopic dermatitis.

NCT ID: NCT05639738 Terminated - Dermatitis, Atopic Clinical Trials

Assessment of Clinical, Biological and Biometrological Paramaters in Adult Subjects Suffering From AD

Start date: March 8, 2022
Phase: N/A
Study type: Interventional

The aim of the study is to collect different parameters (clinical, biological and biometrological) of Atopic Dermatitis (AD) in order to identify which factors are modified during the flare-up phase.