Dermatitis, Atopic Clinical Trial
Official title:
Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis
Background: - Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S. aureus bacteria. Researchers want to study how eczema treatments affect the number and the type of bacteria on the skin. Objectives: - To study the effect of eczema treatments on skin bacteria. Eligibility: - Individuals between 2 and 25 years of age who have moderate to severe atopic dermatitis. - Healthy volunteers between 18 and 40 years of age with no history of eczema. Design: - Participants will be screened with a physical exam and medical history. Research samples will be collected. Skin biopsies may also be performed. - All participants will be assigned to one of several study groups. - This study will last for up to 1 year. Healthy volunteers must not have taken antibiotics in the year before the start of the study. - All participants will have regular study visits during their 1-year participation. More research samples will be collected at these visits.
BACKGROUND: - The use of antibiotics has revolutionized medicine, yet the impact of antimicrobials on the human microbiome is incompletely understood. - Antimicrobial treatments, including topical and systemic antibiotics, are highly effective and are frequently used to manage disease flares of AD. Concomitant use of dilute bleach baths reduces the clinical severity of AD in patients with clinical signs of bacterial skin infections. - The longitudinal impact of various antimicrobials on the human microbiome, particularly in skin, has not been systematically investigated. OBJECTIVES: Primary: -To characterize microbiome alterations in healthy adult volunteers (Cohorts 1 and 2) and patients with AD (Cohort 3) after antimicrobial treatments. ELIGIBILITY: - All subjects must be co-enrolled in NIH protocol 08-HG-0059 - (Cohorts 1 and 2) Healthy volunteers aged 18 to 50 years with no history of AD - (Cohort 1 and 2) No prior use of systemic antibiotics in preceding 12 months - (Cohort 3) Subjects 2-50 years with atopic dermatitis with symptoms of active bacterial infection - (Cohort 3) Objective SCORAD (SCORing Atopic Dermatitis) score of greater than or equal to 15 indicating moderate-to-severe disease DESIGN: - A prospective, interventional, longitudinal study examining changes in microbiome resulting from randomized, placebo-controlled, investigator-blinded antimicrobial treatments. - Subjects in Cohort 1 will be randomized to take one of 4 open label antibiotic regimens. - Subjects from Cohort 2 will be will be randomized to one of four possible blinded treatment combinations of study baths and antibiotics. - Subjects in Cohort 3 will be randomized to a cephalexin regimen with or without study baths. - All subjects will undergo longitudinal microbiome sampling. - AD patients will undergo clinical assessment to determine responses of skin infections to treatment. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03563066 -
Effect of Benralizumab in Atopic Dermatitis
|
Phase 2 | |
Terminated |
NCT04086121 -
A Study to Test the Long-term Safety of BI 655130 in Patients With Atopic Eczema Who Took Part in Study 1368-0032
|
Phase 2 | |
Recruiting |
NCT04011215 -
Wool Clothing for the Management of Childhood Atopic Dermatitis (DESSINE2)
|
N/A | |
Completed |
NCT04635072 -
Stabilized Whole Rice Bran (SWRB) for Mild to Moderate Atopic Dermatitis
|
Early Phase 1 | |
Completed |
NCT02916888 -
A Study Comparing the Quality of Life of Patients in the Treatment of Eczema by Pediatric Generalists and Specialists
|
N/A | |
Completed |
NCT01945086 -
A Study of Ustekinumab (STELARA®) in Adult Japanese Participants With Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT00541255 -
A Long-Term Examination of Asthma From Childhood Through Adolescence
|
||
Terminated |
NCT04990440 -
A Study of Bermekimab for the Treatment of Adult Participants With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT02900131 -
Efficacy, Safety and Dose Finding Trial of Topical Jaungo Application in Atopic Dermatitis Patients
|
Phase 2 | |
Completed |
NCT03568136 -
Investigation of Efficacy of Secukinumab in Patients With Moderate to Serve Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT03672383 -
Functional Study to Investigate the Efficacy of a New Medical Device (Modified Diprobase Formulation)
|
N/A | |
Completed |
NCT03634345 -
Drug Drug Interaction Study Evaluating the Effect of Fluvoxamine or Fluconazole on PK and Safety of PF-04965842.
|
Phase 1 | |
Enrolling by invitation |
NCT04761978 -
Efficacy and Tolerance of JAK Inhibitors in ATU for Atopic Dermatitis
|
||
Completed |
NCT03663673 -
Effect of Different Skin Creams on TEWL
|
Phase 1 | |
Recruiting |
NCT05177744 -
Toxicity of Micro and Nano Plastics Combined With Environmental Contaminants on the Risk of Allergic Disease
|
||
Completed |
NCT03720470 -
Study Evaluating Efficacy and Safety of PF-04965842 and Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis on Background Topical Therapy
|
Phase 3 | |
Completed |
NCT02637206 -
Skin Irritation Study of GSK2894512 Cream
|
Phase 1 | |
Completed |
NCT05544591 -
Evaluation of 611 in Chinese Adults With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
Completed |
NCT05094700 -
A Study of a Polymeric Surfactant Technology Cleanser in Sensitive Skin Participants
|
N/A | |
Terminated |
NCT02582788 -
Bathing Additives in Pediatric Atopic Dermatitis
|
N/A |