NCT01631617

Effects of Treatments on Atopic Dermatitis

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · NIH
• Sex: All
• Age: 2 Years – 50 Years
• Healthy volunteers: Accepted

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.

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 atopic dermatitis (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. * Our recent study demonstrated that antibiotic-resistant bacteria can be observed after antibiotic exposure; however, multi-year persistence has not been evaluated OBJECTIVES: Primary: \- To characterize microbiome alterations in healthy adult volunteers and patients with AD after antimicrobial treatments. ELIGIBILITY: * All subjects must be co-enrolled in NIH protocol 08-HG-0059 * (Cohorts 1 \[NO FURTHER ACCRUAL\], 2 \[INACTIVE\], 4 \[NO FURTHER ACCRUAL\], 5 \[INACTIVE\]) Healthy volunteers aged 18 to 50 years with no history of AD. * (Cohort 1 \[NO FURTHER ACCRUAL\], 2 \[INACTIVE\], 4 \[NO FURTHER ACCRUAL\] and 5 \[INACTIVE\]) No prior use of systemic antibiotics in preceding 12 months. * (Cohort 3 \[INACTIVE\]) Subjects 2-50 years with atopic dermatitis with symptoms of active bacterial infection. * (Cohort 3 \[INACTIVE\]) Objective SCORAD (SCORing Atopic Dermatitis) score of \>= 15 indicating moderate-to-severe disease. * (Cohort 6) Individuals previously enrolled in Cohorts 1 \[NO FURTHER ACCRUAL\] and 4 \[NO FURTHER ACCRUAL\]. DESIGN: * A prospective, interventional, longitudinal study examining changes in microbiome resulting from randomized, placebo-controlled, investigator-blinded antimicrobial treatments. * Subjects in Cohort 1 \[NO FURTHER ACCRUAL\] will be randomized to take one of 4 open label antibiotic regimens. * Subjects from Cohort 2 \[INACTIVE\] randomized to one of four possible blinded treatment combinations of study baths and antibiotics. * Subjects in Cohort 3 \[INACTIVE\] will be randomized to a cephalexin regimen with or without study baths. * Subjects in Cohorts 4 \[NO FURTHER ACCRUAL\] and 5 \[INACTIVE\] will receive one of two open label antibiotic regimens. * All subjects will undergo longitudinal microbiome sampling. * Subjects who completed on-protocol antibiotic regimen in Cohorts 1 \[NO FURTHER ACCRUAL\] and 4 \[NO FURTHER ACCRUAL\] may be recruited \>1 year after completion of Cohorts 1 and 4 to undergo an optional single visit for microbiome sampling as Cohort 6. * AD patients \[INACTIVE\] will undergo clinical assessment to determine responses of skin infections to treatment.

Conditions

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

Interventions

Type	Name	Description
DRUG	Trimethoprim/sulfamethoxazole (TMP/SMZ)	800/160 orally every 12 hours for 14 days
DRUG	Cephalexin	500 mg orally every 8 hours for 14 days
DRUG	Doxycycline	20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days
OTHER	Sodium hypochlorite	6 % dilute bleach
OTHER	Placebo capsules	Capsule orally every 8 hours daily for 14 days
OTHER	Placebo Sodium hypochlorite	Three times a week for 14 days

Timeline

• Start date: 2012-09-18
• Primary completion: 2027-01-01
• Completion: 2027-01-01
• First posted: 2012-06-29
• Last updated: 2026-04-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study