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Dermatitis, Atopic clinical trials

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NCT ID: NCT05222516 Terminated - Atopic Dermatitis Clinical Trials

Immunomodulation by OM-85 (Broncho-Vaxom) in Early AD

Start date: December 20, 2021
Phase: Phase 2
Study type: Interventional

Clinical data suggest that treatment with OM-85, by inducing an early contact with bacterial extracts, could modulate the immunity of children with Atopic Dermatitis, and thus play an active role in the treatment of Atopic Dermatitis. The present trial will investigate the influence of administration of OM-85 in the paediatric population younger than 24 months with moderate atopic dermatitis. The efficacy and safety of OM-85 will be evaluated in children aged 3 to 24 months old with moderate Atopic Dermatitis who may benefit from treatment with OM-85. The placebo treatment period will serve as a reference and has been added to establish efficacy and safety.

NCT ID: NCT05215808 Recruiting - Atopic Dermatitis Clinical Trials

SAD/MAD Safety and PK Study of RBN-3143 in Healthy and Atopic Dermatitis Subjects

Start date: March 7, 2022
Phase: Phase 1
Study type: Interventional

RBN-3143 Background: PARP proteins are members of a family of seventeen ADP-ribosyltransferase (ART) enzymes that regulate cellular processes including gene expression, protein degradation, and multiple cellular stress responses. RBN-3143 is a PARP-14 inhibitor. PARP14 is over-expressed in tissues with inflammatory diseases. RBN-3143 is a novel, orally administered PARP14 inhibitor that was developed to be evaluated as therapy for a range of inflammatory diseases, with an initial focus on Atopic Dermatitis. Study Overview: The study consists of 2 parts. Part A: This part of the study is being conducted in a clinical research unit (CRU) and is enrolling healthy adult subjects to determine the safety of RBN-3143; its absorption, metabolism, and excretion (what the body does to this drug); and will assess its potential pharmacodynamic properties (what the drug does to the body). There are 3 subsections to this part of the study. The first segment was conducted in a double-blind manner (neither the investigator nor subject knew if placebo or RBN-3143 was given) to assess dosing regimens of RBN-3143 when taken in a fasted state (before food). The last two segments are currently recruiting and are Open Label (all subjects will receive RBN-3143) and will assess RBN-3143 when taken with food, with pantoprazole, a medication that decreases the amount of acid in the stomach, and with midazolam. Part B: In early 2023 the second part of the study will be conducted in patients with moderate to severe atopic dermatitis to measure the pharmacodynamic activity of RBN-3143 and evaluate preliminary efficacy of 28 days administration of the study drug. All patients will receive the same dose of RBN-3143.

NCT ID: NCT05214326 Completed - Dermatitis Atopic Clinical Trials

A Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Male and Female Participants of Atleast 12 Years Old Receiving Dupilumab Injections in Gulf Countries

AD-impaCT
Start date: January 18, 2022
Phase:
Study type: Observational

Primary objective: To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment. Secondary objectives: - To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment. - To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24. - Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD). - To describe comorbidities related to type 2 inflammation. - To characterize the safety profile of dupilumab in the local Gulf population. - To evaluate treatment satisfaction in the local Gulf population.

NCT ID: NCT05203380 Completed - Clinical trials for Moderate-to-severe Atopic Dermatitis

Neuropsychologic Assessments of Dupilumab-Treated Adolescent Participants With Moderate-to-Severe Atopic Dermatitis

NEURADAD
Start date: January 27, 2022
Phase:
Study type: Observational

Primary Objective: Part A - To quantify deficits in cognitive functioning in adolescents with moderate-to-severe AD, using the Conners' Continuous Performance Test 3rd Edition (CPT-3) d' T-score - To determine the entry criterion (CPT-3 d' score) for Part B Primary Objective: Part B - To measure changes in cognitive functioning in adolescents with moderate-to-severe AD treated with dupilumab Secondary Objectives - To evaluate the relationship of cognitive and sensory functioning with severity of AD in adolescent AD patients - To evaluate the relationship between changes in AD severity and changes in cognitive and sensory functioning scores following treatment with dupilumab (Part B only).

NCT ID: NCT05200403 Terminated - Atopic Dermatitis Clinical Trials

Improvement In Scratch Behavior And Sleep In Patients With Atopic Dermatitis

PAD
Start date: July 26, 2022
Phase: Phase 4
Study type: Interventional

This single blind study is to primarily evaluate wearable devices and Observer Reported Itch Assessment in children to assess reduction of itch and night-time scratch in response to Crisaborole treatment vs. vehicle treatment (active control comparator without crisaborole) in children with atopic dermatitis (AD). Participants, age 3 months to 11 years with symptomatic mild to moderate AD, along with their primary caregivers will be recruited. The goal of this study is to more fully evaluate the rapid onset of night-time itch and scratch relief, as well as improvements in sleep following treatment with Crisaborole in comparison to vehicle treatment in children with AD. the study will also assess the quality of life (QoL) and sleep within the associated caregivers.

NCT ID: NCT05197023 Not yet recruiting - Clinical trials for Moderate to Severe Atopic Dermatitis

A STUDY TO EVALUATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF MULTIPLE SUBCUTANEOUS INJECTIONS OF SHR-1819 IN PATIENTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS

Start date: January 2022
Phase: Phase 1
Study type: Interventional

The study will be conducted to evaluate the safety and tolerability of SHR-1819 injection and describe the PK/PD/ADA and explore the clinical efficacy.

NCT ID: NCT05194540 Completed - Atopic Dermatitis Clinical Trials

Efficacy and Safety of Tralokinumab Administered by an Autoinjector in Adults and Adolescents With Moderate to Severe Atopic Dermatitis (INJECZTRA)

INJECZTRA
Start date: January 13, 2022
Phase: Phase 3
Study type: Interventional

The purpose of this trial is to evaluate the efficacy and safety of tralokinumab administered as subcutaneous (SC) injection by an autoinjector in adults and adolescents (age 12 to 17 years) with moderate-to-severe atopic dermatitis (AD).

NCT ID: NCT05186922 Recruiting - Clinical trials for Moderate-to-severe Atopic Dermatitis

The Study of CM326 in Patients With Moderate-to-severe Atopic Dermatitis

Start date: February 17, 2022
Phase: Phase 1/Phase 2
Study type: Interventional

This is a multi-center, randomized, double blind, placebo-controlled multiple dose escalation study to evaluate the safety, tolerance, PK, PD, immunogenicity and preliminary efficacy of CM326 in moderate-severe AD subjects.

NCT ID: NCT05186805 Completed - Atopic Dermatitis Clinical Trials

Maximal Use Study of Tapinarof Cream, 1% in Pediatric Subjects With Extensive Atopic Dermatitis

Start date: November 15, 2021
Phase: Phase 2
Study type: Interventional

This is an open-label, multicenter study to evaluate the systemic exposure and safety of topical tapinarof cream, 1% under conditions of maximal use in pediatric subjects with atopic dermatitis

NCT ID: NCT05178433 Not yet recruiting - Atopic Dermatitis Clinical Trials

Skin Care Strategies for Neonatal Jaundice Phototherapy to Prevent Atopic Dermatitis in Moderate and Severe Infants

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Atopic Dermatitis (AD) is a common chronic, recurrent, and inflammatory skin disease in children. The incidence of moderate to severe AD in infants aged 1-12 months in our country is as high as 25.41%, which is related to subsequent allergic diseases and affects Children's emotions and growth. There are limited drugs that can be used for infant AD. The current guidelines recommend early use of functional skin care products to prevent and treat AD by repairing the skin barrier, moisturizing, and anti-inflammatory. Neonatal jaundice is one of the most common neonatal diseases. 20% of children with jaundice need phototherapy. It is a simple and effective method for jaundice. Studies have found that phototherapy can convert Th2 to Th1, leading to an imbalance of pro-inflammatory and anti-inflammatory, which induces allergies. We speculate that it is of great value to take protective measures such as skin moisturizing during phototherapy for jaundice in children at high risk of allergies. This project intends to take the lead in conducting a randomized controlled study on the use of baby moisturizing products during neonatal phototherapy. Through evaluation projects such as skin microecology analysis, serum allergy indicators and AD clinical manifestations, it is verified that the use of functional skin care products in phototherapy of newborns with high allergies can delay and reduce the severity of AD in infants.