Effects of Treatments on Atopic Dermatitis
- 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.
Other: Sodium hypochlorite (bleach)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis|
- To characterize microbiome alterations in healthy adult volunteers (Cohorts 1 and 2) and pediatric patients with AD and associated active bacterial infection (Cohort 3) after treatment. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
- To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes. To examine how different treatments may alter the human microbiome. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||June 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
- 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 pediatric patients with AD (Cohort 3) after antimicrobial treatments.
- To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes.
- To examine how different antimicrobials may alter the human microbiome.
- All subjects must be co-enrolled in NIH protocol 08-HG-0059
- (Cohorts 1 and 2) Healthy volunteers aged 18 to 40 years with no history of AD
- (Cohort 1 and 2) No prior use of systemic antibiotics in preceding 12 months
- (Cohort 3) Subjects 2-25 years with atopic dermatitis with symptoms of active
-(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 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631617
|Contact: Sheila E Phang, R.N.||(301) firstname.lastname@example.org|
|Contact: Heidi H Kong, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|Contact: Sheila Phang, B.S. (301) 435-9379 firstname.lastname@example.org|
|Principal Investigator:||Heidi H Kong, M.D.||National Cancer Institute (NCI)|