Study on Treatments for Atopic Dermatitis and Skin Bacteria
This study is looking at how different treatments for atopic dermatitis (eczema) affect the types and numbers of bacteria on the skin. Researchers want to understand how antibiotics like Trimethoprim/sulfamethoxazole (TMP/SMZ), Cephalexin, and Doxycycline, as well as dilute bleach (Sodium hypochlorite), change the skin's microbiome (the community of tiny living things on your skin). You might be able to join if you are between 2 and 25 years old with moderate to severe eczema, or if you are a healthy volunteer between 18 and 40 years old. The main goal is to see how these treatments alter the skin's bacteria after two weeks. The current status of the study is unclear, and some groups of healthy volunteers are no longer accepting new participants.
- Study design
- This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 130 participants, who will be assigned to one of several study groups.
- What's involved
- You will be screened with a physical exam and medical history, and research samples will be collected. Skin biopsies may also be performed.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoint for measuring changes in skin bacteria is at 2 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT01631617
Effects of Treatments on Atopic Dermatitis
Recruiting
PHASE2Ages 2–50InterventionalTreatmentNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Government-funded
~130 participants
Updated 2026-08-28 on ClinicalTrials.gov
What's tested:Trimethoprim/sulfamethoxazole (TMP/SMZ)CephalexinDoxycyclineSodium hypochloritePlacebo capsulesPlacebo Sodium hypochlorite
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Characterize microbiome alterations
Measured over 2 weeks
Conditions
Where it's being run
1 sites across 1 statesMaryland1
Study leadership
- Heidi H Kong, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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
Ability of subject to understand and provide written informed consent
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
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
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
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
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.
What this trial measures
- Characterize microbiome alterations2 weeks
Difference in Shannon Diversity Indices (SDI) from baseline to day 14.