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.
To study the effect of eczema treatments on skin bacteria.
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.
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.
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.
-To characterize microbiome alterations in healthy adult volunteers (Cohorts 1 and 2) and
patients with AD (Cohort 3) after antimicrobial treatments.
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
(Cohort 3) Objective SCORAD (SCORing Atopic Dermatitis) score of greater than or equal
to 15 indicating moderate-to-severe disease
A prospective, interventional, longitudinal study examining changes in microbiome
resulting from randomized, placebo-controlled, investigator-blinded antimicrobial
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
All subjects will undergo longitudinal microbiome sampling.
AD patients will undergo clinical assessment to determine responses of skin infections
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.