Effects of Treatments on Atopic Dermatitis

Phase 2

Recruiting

• Conditions: Skin Diseases, Genetic; Dermatitis, Atopic; Dermatitis; Skin Diseases; Eczema
• Interventions: Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ); Drug: Cephalexin; Drug: Doxycycline; Other: Placebo Sodium hypochlorite; Other: Placebo capsules; Other: 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.

* 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.

Study Timeline

• Study First Submitted: 2012-06-28
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-06-29
• Study Start: 2012-09-18
• Status Verified: 2025-05-27
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-14
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

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