Scientists probe how eczema drugs alter skin microbes
NCT ID NCT01631617
First seen Jun 26, 2026 · Last updated Sep 17, 2026 · Updated 20 times
Summary
This study examines how common eczema treatments, including antibiotics and bleach baths, change the types and amounts of bacteria on the skin. Researchers will compare people with eczema to healthy volunteers. The goal is to understand the skin microbiome better, not to test a new treatment.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- antibiotics (trimethoprim/sulfamethoxazole, cephalexin, doxycycline) and dilute bleach
- What this could lead to
- If successful, this could help doctors understand how eczema treatments change skin bacteria, potentially leading to better treatment strategies.
- What could go wrong
- This is an early-phase study focused on measuring bacteria, not on curing or treating eczema. The results may not directly lead to new treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 130 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2012
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 50 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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