Effects of Treatments on Atopic Dermatitis

Dermatitis, Atopic Clinical Trial

Official title: Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Genetic Diseases, Inborn
• Skin Diseases
• Skin Diseases, Genetic

• NCT number: NCT01631617
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Monica Taylor, R.N.
• Phone: (301) 451-2221
• Email: monica.taylor@nih.gov
• Status: Recruiting
• Phase: Phase 2
• Start date: September 18, 2012
• Completion date: January 1, 2025