Investigating how eczema treatments affect skin bacteria
Official title: Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis
Run by National Institutes of Health Clinical Center (CC) · NCT01631617 · Data updated 2026-11-12
This study is testing how different eczema treatments affect the skin bacteria in people with moderate to severe eczema and healthy volunteers.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 2 Years to 50 Years |
| Sex | All |
| Enrollment | 130 (estimated) |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | September 18, 2012 |
| Main results expected | January 1, 2027 |
| Study ends | January 1, 2027 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT01631617 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 2 to 50 years with moderate to severe atopic dermatitis and signs of bacterial skin infections.
✕Probably not a fit
Patients with mild eczema or those who have not experienced bacterial infections may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to explore the effects of various antimicrobial treatments on the skin microbiome in individuals with atopic dermatitis and healthy volunteers. Participants aged 2 to 50 with moderate to severe eczema will be enrolled alongside healthy individuals aged 18 to 50. The study will involve randomization into different treatment groups, including antibiotics and placebo, with regular follow-up visits and skin biopsies to assess changes in skin bacteria. The goal is to better understand how these treatments impact bacterial populations on the skin.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for managing atopic dermatitis and its associated bacterial infections.
How similar studies have gone: Previous studies have shown promising results in understanding the impact of antibiotics on skin conditions, but this specific approach to studying the microbiome in atopic dermatitis is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
* INCLUSION CRITERIA: Cohorts 1 \[NO FURTHER ACCRUAL\], 2 \[INACTIVE\], 4 \[NO FURTHER ACCRUAL\] and 5 \[INACTIVE\]: Healthy Volunteers * Males and females aged 18-50 years at time of initial protocol sampling * Subjects must participate fully and be willing to comply with the procedures of the protocol * Subjects must be co-enrolled in NIH protocol 08-HG-0059 * Ability of subject to understand and provide written informed consent * Access to bathing facilities (Cohort 2 \[INACTIVE\]) * Ability to swallow capsules or tablets Cohort 3 \[INACTIVE\]: Atopic Dermatitis Patients * Subjects must be aged 2-50 years * Subjects must be co-enrolled in NIH protocol 08-HG-0059 * Subjects must have a diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party s Diagnostic Criteria for Atopic Dermatitis * Subjects must have a primary care provider * Subjects must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe * Prior to initiation of randomized treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and/or pustules) * Access to bathing facilities * All subjects and/or their Legally Authorized Representative (LAR) must have the ability and agree to participate fully and comply with the procedures of the protocol and provide informed consent. Pediatric patients will be included in age appropriate discussions and age appropriate assent will be obtained in accordance with NIH guidelines. -Ability of subject to understand and provide written informed consent Cohort 6: Healthy Volunteers * Subjects previously enrolled in Cohorts 1 \[NO FURTHER ACCRUAL\] and 4 \[INACTIVE\] who completed on-protocol antibiotic regimen * Subjects must participate fully and be willing to comply with the procedures of the protocol * Ability of subject to understand and provide written informed consent EXCLUSION CRITERIA: Cohorts 1 \[NO FURTHER ACCRUAL\] and 2 \[INACTIVE\]: Healthy Volunteers * Does not meet inclusion criteria * Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause * Use of systemic antibiotics in 12 months preceding baseline sampling * Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling * Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment * Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or lidocaine or epinephrine * Family history of toxic epidermal necrolysis * Known allergy or sensitivity to sodium hypochlorite (NaOCl) * History of AD or asthma * Inability to comply with the requirements of the protocol * Pregnant or lactating * Subjects with a primary or acquired immunodeficiency, including HIV seropositiviy * Any chronic past or present medical illness, including chronic skin diseases like psoriasis * Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants * Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals Cohort 3 \[INACTIVE\]: Atopic Dermatitis Patients * Does not meet inclusion criteria * Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause * Known allergic reaction to beta-lactam class drugs, lidocaine, or epinephrine * Family history of toxic epidermal necrolysis * Known allergic reaction to sodium hypochlorite (NaOCl) * Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling * Use of topical corticosteroids on all intended sampling sites within 7 days, prior to baseline sampling * Use of topical or oral CAM agents within 4 weeks of initiation of treatment * Subjects with known primary or acquired immunodeficiency * Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the initial month of the study or who have been hospitalized for treatment of these conditions in the one month prior to baseline sampling * Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants within 7 days or 5 half-lives (whichever is the longer time period) of initiating treatment on this protocol * Subjects who are currently receiving or have received chemotherapy or radiation for treatment of malignancies within the previous 6 months * Pregnancy or lactating Cohorts 4 \[NO FURTHER ACCRUAL\] and 5 \[INACTIVE\]: Healthy Volunteers * Does not meet inclusion criteria * Any female with symptoms and/or serum hormone levels consistent with perimenopause or menopause * Use of systemic antibiotics in 12 months preceding baseline sampling * Use of swimming pools, hot tubs, or whirlpools in 7 days preceding baseline sampling * Use of topical or oral complementary/alternative medicine (CAM) agents within 4 weeks of initiation of treatment * (Cohort 4 \[NO FURTHER ACCRUAL\]) Known allergic reaction to sulfa class drugs; or lidocaine or epinephrine * (Cohort 5 \[INACTIVE\]) Known allergic reaction to tetracycline class drugs; or lidocaine or epinephrine * Family history of toxic epidermal necrolysis * History of AD or asthma * Inability to comply with the requirements of the protocol * Pregnant or lactating * Subjects with a primary or acquired immunodeficiency, including HIV seropositivity * Any chronic past or present medical illness, including chronic skin diseases like psoriasis * Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants * Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals Cohort 6: Healthy Volunteers * Does not meet inclusion criteria * Use of swimming pools, hot tubs, or whirlpools in 7 days preceding sampling * Use of topical or oral CAM agents within 1 week or 4 weeks, respectively, prior to sampling * Pregnant or lactating females in all cohorts are excluded from participating due to the potential effects of the above listed antimicrobials on the developing human fetus or nursing infant; listed in Sections 11.1 through 11.5. Females of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Lactating mothers will discontinue breastfeeding prior to study enrollment. * Smokers and subjects who use smokeless tobacco products are excluded in all cohorts due to tobacco s unknown impact on human oral mucosa and microflora.
Where it's running
-
National Institutes of Health Clinical Center
Bethesda, Maryland, United States Recruiting
Study contacts
- Principal investigator: Heidi H Kong, M.D. — National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Study coordinator: Heidi H Kong, M.D.
- Email: NIAMSderm@nih.gov
- Phone: (301) 827-2460
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.