Effects of Treatments on Atopic Dermatitis
- Conditions
- Skin Diseases, GeneticDermatitis, AtopicDermatitisSkin DiseasesEczema
- Interventions
- Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)Other: Placebo Sodium hypochloriteOther: Placebo capsulesOther: Sodium hypochlorite
- Registration Number
- NCT01631617
- Lead Sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 130
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2B/Cephalexin + Placebo bleach Placebo Sodium hypochlorite Systemic antibiotics (Cephalexin) + placebo study bath liquid 2C/Placebo capsules + Dilute bleach Placebo capsules Placebo capsules + dilute bleach study bath liquid 1C/Doxycycline 100 Sodium hypochlorite Doxycycline 100 mg orally every 12 hours for 56 days 2D/Placebo capsules + Placebo bleach Placebo Sodium hypochlorite Placebo capsules + placebo study bath liquid 3A/Cephalexin + Dilute bleach Sodium hypochlorite Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid 1B/TMP/SMX Trimethoprim/sulfamethoxazole (TMP/SMZ) TMP/SMZ DS 800 /160 orally every 12 hours for 14 days 3B/Cephalexin + Placebo bleach Placebo Sodium hypochlorite Systemic antibiotics (Cephalexin) + placebo study bath liquid 2A/Cephalexin + Dilute bleach Sodium hypochlorite Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid 2C/Placebo capsules + Dilute bleach Sodium hypochlorite Placebo capsules + dilute bleach study bath liquid 2D/Placebo capsules + Placebo bleach Placebo capsules Placebo capsules + placebo study bath liquid 2A/Cephalexin + Dilute bleach Cephalexin Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid 1A/Cephalexin Cephalexin Cephalexin + Placebo bleach 1C/Doxycycline 100 Cephalexin Doxycycline 100 mg orally every 12 hours for 56 days 1D/Doxycycline 20 Doxycycline Doxycycline 20 mg orally every 12 hours for 56 days 2B/Cephalexin + Placebo bleach Cephalexin Systemic antibiotics (Cephalexin) + placebo study bath liquid 3A/Cephalexin + Dilute bleach Cephalexin Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid 3B/Cephalexin + Placebo bleach Cephalexin Systemic antibiotics (Cephalexin) + placebo study bath liquid
- Primary Outcome Measures
Name Time Method Characterize microbiome alterations 2 weeks Difference in Shannon Diversity Indices (SDI) from baseline to day 14.
- Secondary Outcome Measures
Name Time Method To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes. Throughout the duration of the study To examine how different antimicrobials may alter the human microbiome. Throughout the duration of the study
Trial Locations
- Locations (1)
National Institutes of Health Clinical Center
🇺🇸Bethesda, Maryland, United States