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Dermatitis, Atopic clinical trials

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NCT ID: NCT05131477 Completed - Atopic Dermatitis Clinical Trials

Study Testing Response Effect of KY1005 Against Moderate-to-Severe Atopic Dermatitis, The STREAM-AD Study

STREAM-AD
Start date: December 13, 2021
Phase: Phase 2
Study type: Interventional

This is an interventional, randomized, parallel group, treatment, Phase IIb, double blind, 5-arm study to assess the effect of Anti-OX40L Monoclonal Antibody (KY1005) in adult participants with moderate to severe atopic dermatitis. The estimated duration is 28 days for screening and then up to approximately day 477 (last dose no later than day 337+140 days safety follow-up) for all patients unless enrolled into the LTE (Long-Term Extension) protocol (NCT05492578) at either Day 169 depending on responder status or no later than Day 365 due to loss of clinical response.

NCT ID: NCT05127421 Completed - Atopic Dermatitis Clinical Trials

Ruxolitinib Cream in Participants With Facial and/or Neck Atopic Dermatitis Involvement

Start date: November 10, 2021
Phase: Phase 2
Study type: Interventional

This is a randomized, double blind, vehicle controlled Phase 2 study with a 4-week open label extension in adolescent and adult participants with atopic dermatitis and head and/or neck involvement. It is intended to compare the efficacy and safety of ruxolitinib cream 1.5% BID versus vehicle cream, then further evaluate ruxolitinib cream as maintenance during the open label extension period.

NCT ID: NCT05121480 Completed - Atopic Dermatitis Clinical Trials

A Study Investigating the Effect of EDP1815 in the Treatment of Mild, Moderate and Severe Atopic Dermatitis

Start date: January 31, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this research study is to determine whether the study drug, EDP1815, is safe and effective in the treatment of atopic dermatitis compared with placebo. The study will look at different doses of the study drug, and whether there are differences when the drug is given once daily or twice daily.

NCT ID: NCT05117060 Completed - Atopic Dermatitis Clinical Trials

Efficacy and Safety of LEO 152020 Tablets for the Treatment of Adults With Moderate to Severe Atopic Dermatitis

Start date: December 13, 2021
Phase: Phase 2
Study type: Interventional

This is an up to 22-week clinical study in adult participants with moderate to severe atopic dermatitis (AD). The purpose of the study is to test a new tablet (LEO 152020) to see if it improves AD and what the side effects are when compared with a placebo tablet with no medical ingredient. During the study, there will be a 16-week treatment period during which the participants will be asked to take the tablets. The participants will regularly visit the clinic for tests and the study doctor will evaluate their AD. The participants will also be asked to answer questions about their AD symptoms, itch, sleep, and quality of life.

NCT ID: NCT05114889 Completed - Atopic Dermatitis Clinical Trials

Safety and Tolerability of BSI-045B in Healthy Adult Subjects and Patients With Atopic Dermatitis

Start date: October 25, 2021
Phase: Phase 1
Study type: Interventional

This randomized, double-blind, single center, placebo-controlled, phase 1 single ascending dose (SAD)/multiple ascending dose (MAD) study is designed to assess the safety, tolerability, PK, activity, immunogenicity, and PD of BSI-045B. Approximately 68 subjects will be enrolled. Subjects in this study include 56 healthy volunteers (HVs) and 12 patients with AD. This study is divided into 3 parts: 1. Part A: Evaluate the safety, tolerability, PK, immunogenicity, and PD of single ascending doses of BSI-045B administered as a subcutaneous (SC) injection of 120, 240, 480, and 720 mg to HVs 2. Part B: Evaluate the safety, tolerability, PK, activity (as measured by the Eczema Area and Severity Index [EASI] score), immunogenicity, and PD of a single dose of BSI-045B administered as a SC injection of 480 mg to patients with AD 3. Part C: Evaluate the safety, tolerability, PK, immunogenicity, and PD of multiple ascending doses of BSI-045B administered as five (5) SC injections of 240, 480, and 600 mg every 7 days (Q7D) to HVs

NCT ID: NCT05099315 Recruiting - Atopic Dermatitis Clinical Trials

Microbiome in Atopic Dermatitis Under Systemic Therapy

BIO-AD
Start date: October 1, 2019
Phase:
Study type: Observational [Patient Registry]

The skin microbiome plays a role in the pathogenesis of atopic dermatitis. However, it is unclear whether the range of microbiota on the skin is the cause or consequence of atopic skin inflammation. The influence of new systemic therapies for the treatment of moderate to severe atopic dermatitis (such as biologics or Janus kinase inhibitors) on the skin microbiome is largely unknown. The main aim of this scientific exploratory study is to investigate whether and how the skin microbiome changes in patients with moderate to severe atopic dermatitis during systemic therapy. This not only allows new hypotheses to be generated on the pathogenesis of atopic dermatitis, but also new objective scales for the severity of atopic dermatitis can be developed.

NCT ID: NCT05099133 Completed - Atopic Dermatitis Clinical Trials

A Trial to Evaluate Pharmacokinetics, Immunogenicity, Safety, and Tolerability of LEO 138559 in Healthy Japanese Subjects

Start date: November 3, 2021
Phase: Phase 1
Study type: Interventional

This trial will investigate the pharmacokinetics, immunogenicity, safety, and tolerability of LEO 138559 in healthy Japanese subjects. The trial consists of a screening period of up to 4 weeks, a single treatment with either LEO 138559 or placebo, and 8 follow-up visits to Day 85. A total of 24 healthy subjects will be enrolled in 3 dose groups (n=8 per dose group) and randomized to either LEO 138559 or placebo in a ratio of 6:2.

NCT ID: NCT05098821 Recruiting - Atopic Dermatitis Clinical Trials

Extrinsic and Intrinsic Factors in Atopic Dermatitis Upon Systemic Immune Modulation

AD-Sys
Start date: October 1, 2019
Phase:
Study type: Observational [Patient Registry]

Currently, patients with moderate to severe atopic dermatitis are treated with dupilumab if unresponsive to topical treatment. However, not all patients who suffer from atopic dermatitis respond similarly to this treatment. Pattern recognition of immune cells (PRI) is an efficient method to screen patients to allow a more personalized therapy. The main aim of this scientific explorative study is to unravel the changes in peripheral blood immune cell compositions in patients with atopic eczema undergoing dupilumab treatment. This allows the identification of phenotypes of treatment responders and non-responders and possible approaches of treatment modifications for non-responders.

NCT ID: NCT05094700 Completed - Acne Vulgaris Clinical Trials

A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants

Start date: October 25, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to evaluate the efficacy and tolerance of a gentle facial cleanser in participants with sensitive skin (eczema/atopic dermatitis, rosacea, acne, cosmetic intolerance syndrome).

NCT ID: NCT05092464 Not yet recruiting - Atopic Dermatitis Clinical Trials

Exploratory Study to Evaluate the Application of NLAC Cream in Adults With Atopic Dermatitis

Start date: October 31, 2021
Phase: N/A
Study type: Interventional

Atopic dermatitis (AD) is the most common chronic inflammatory skin disorder, with a lifetime prevalence of 15-25% in children and 1-3% in adults worldwide. AD is a heterogeneous disease induced by multiple factors, including genetic mutation and environmental risk factors. The main inflammatory mechanism that contributed to AD is the immune response mediated by T helper 2 (Th2) cells. The clinical features of AD, such as recurrent eczematous lesions, IgE-mediated intense itch, and the disruption of skin barrier induced by abnormal epidermal cell differentiation and protein structures, etc., can be attributed to the secretion of Th2 cell-related cytokines. AD is likely to be a lifelong illness with repeated onsets, causing not only physiological discomfort but also psychological distress; hence the quality of life of AD patients is inevitably affected. Lactic acid is a natural moisturizing factor, which exists in healthy skin. It can efficiently prevent water loss from the skin and alleviate allergic reactions caused by dry skin. The moisturized function of lactic acid has made it became a commonly used additive in a wide variety of skincare products, such as lotion, cream, butter and spray. This product is rich in natural lactic acid generated by the fermentation of probiotics, and therefore can relieve skin itching caused by skin dryness, and resume the water-holding capability of the skin by removing abnormally proliferative stratum corneum as well as inducing collagen production. Importantly, this product is a steroid-free product with safety and without any induced adverse effects in use. This product is also can be a promising option other than steroids to be applied for the mitigation of recurrent symptoms in atopic dermatitis by resuming the water-retention ability of skin and rebuilding skin barrier function.