RecruitingPhase 2NCT01631617

Effects of Treatments on Atopic Dermatitis

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


Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Enrollment

130 participants

Start Date

Sep 18, 2012

Study Type

INTERVENTIONAL

Conditions

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. * 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. * Healthy volunteers may be asked to come in for a one-time follow up after the 1 year mark.


Eligibility

Min Age: 2 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how different treatments — including antibiotics and bleach baths — affect the skin bacteria and immune responses in people with atopic dermatitis (eczema) and in healthy volunteers, to develop better therapies for eczema. You may be eligible if: - You are aged 2–50 years with diagnosed moderate-to-severe atopic dermatitis and signs of bacterial skin infection, or - You are a healthy adult volunteer aged 18–50 years (for comparison cohorts) - You are also co-enrolled in the related NIH protocol 08-HG-0059 (for some cohorts) You may NOT be eligible if: - You are pregnant or breastfeeding - You have a known immune deficiency or HIV - You have used systemic antibiotics in the past 12 months (for healthy volunteers) - You have a history of eczema or asthma (for healthy volunteer cohorts) - You have used systemic antibiotics within 8 weeks (for eczema patients) - You are receiving or plan to receive immunosuppressants, biologics, or UV therapy - You smoke or use tobacco products - You are a perimenopausal or menopausal woman (for some cohorts) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrimethoprim/sulfamethoxazole (TMP/SMZ)

800/160 orally every 12 hours for 14 days

DRUGCephalexin

500 mg orally every 8 hours for 14 days

DRUGDoxycycline

20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days

OTHERSodium hypochlorite

6 % dilute bleach

OTHERPlacebo capsules

Capsule orally every 8 hours daily for 14 days

OTHERPlacebo Sodium hypochlorite

Three times a week for 14 days


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT01631617


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