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Dermatitis, Atopic clinical trials

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NCT ID: NCT06447506 Not yet recruiting - Dermatitis, Atopic Clinical Trials

Long-Term Study (AtDvance) to Evaluate GSK1070806 in Atopic Dermatitis.

AtDvance
Start date: June 4, 2024
Phase: Phase 2
Study type: Interventional

The study is designed to evaluate the long-term safety and efficacy of GSK1070806 in participants with moderate-to severe atopic dermatitis, who have completed phase 2b parent GSK atopic dermatitis (AtD) study (NCT05999799).

NCT ID: NCT06444165 Not yet recruiting - Atopic Dermatitis Clinical Trials

Lebrikizumab Pen Ease of Use in Participants With Atopic Dermatitis

Start date: June 2024
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the ease of use of the lebrikizumab pen. Participants will use a practice pad to simulate administration of a dose. Participants will complete the modified Subcutaneous Administration Assessment Questionnaire (mSQAAQ) following the simulated injection. This study involves one study visit.

NCT ID: NCT06415175 Not yet recruiting - Atopic Dermatitis Clinical Trials

Study in Paediatric Patients With Atopic Dermatitis Treated With Dupilumab in Spain

PROADAP
Start date: May 31, 2024
Phase:
Study type: Observational

This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.

NCT ID: NCT06397911 Not yet recruiting - Atopic Dermatitis Clinical Trials

Evaluate Efficacy, Pharmacokinetics, and Safety of Repeat Subcutaneous Doses of FB825 in Adults With Moderate-to-Severe Atopic Dermatitis

Start date: July 16, 2024
Phase: Phase 2
Study type: Interventional

This is a randomized, placebo-controlled and double-blind study to evaluate the efficacy, pharmacokinetics, and Safety of repeat subcutaneous doses of FB825 in adults with moderate-to-severe atopic dermatitis.

NCT ID: NCT06397781 Not yet recruiting - Atopic Dermatitis Clinical Trials

Effect of S. Aureus Skin Decolonization on Disease Severity in Atopic Dermatitis Patients

Start date: September 1, 2024
Phase: Phase 4
Study type: Interventional

Our hypothesis is that S. aureus skin decolonization in atopic dermatitis reduces disease severity and favorably alters the function and gene expression of epidermal and immune skin cells that contribute to disease severity.

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: 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: NCT06353087 Not yet recruiting - Dermatitis, Atopic Clinical Trials

Abrocitinib Taiwan Treatment Pattern and Real World Study in ATopiC Dermatitis (ATTRACT Registry)

ATTRACT
Start date: April 1, 2024
Phase:
Study type: Observational [Patient Registry]

This study is to describe the real-world treatment patterns and clinical outcomes in moderate-to-severe AD patients receiving abrocitinib over a 12-month observation period, and to describe patient demographic and baseline characteristics.

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: NCT06324812 Not yet recruiting - Dermatitis, Atopic Clinical Trials

Evaluation of 611 in Chinese Children and Adolescents With Moderate to Severe Atopic Dermatitis

Start date: March 2024
Phase: Phase 1/Phase 2
Study type: Interventional

The primary objective of the study was to evaluate the safety and pharmacokinetic of 611 in Chinese children and adolescents with moderate to severe atopic dermatitis.