EczemaPhase 2NCT01631617
Effects of Treatments on Atopic Dermatitis
A Phase 2 study testing Trimethoprim/sulfamethoxazole (TMP/SMZ), Cephalexin and Doxycycline in people with Eczema and Dermatitis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Eczema, Dermatitis, Skin Diseases, Genetic
- What is being tested?
- Trimethoprim/sulfamethoxazole (TMP/SMZ), Cephalexin and Doxycycline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2012to 1 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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])
Show all 23Show fewer
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov
About this study
Official title: Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis
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.
Read more
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.
Read the 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
- Being tested
- Trimethoprim/sulfamethoxazole (TMP/SMZ), Cephalexin, Doxycycline, Sodium hypochlorite, Placebo capsules
- Keywords
- Investigator-Blinded, Skin Biopsy, Randomized, Antibiotics, Topical
- Medical subject headings
- Eczema, Dermatitis, Skin Diseases, Genetic, Dermatitis, Atopic, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trimethoprim/sulfamethoxazole (TMP/SMZ)Drug
800/160 orally every 12 hours for 14 days
CephalexinDrug
500 mg orally every 8 hours for 14 days
DoxycyclineDrug
20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days
Sodium hypochloriteOther
6 % dilute bleach
Placebo capsulesOther
Capsule orally every 8 hours daily for 14 days
Placebo Sodium hypochloriteOther
Three times a week for 14 days
| Study group | Role | What they receive |
|---|---|---|
| 1A/Cephalexin | Active comparator | Cephalexin + Placebo bleach Receives: Drug: Cephalexin |
| 1B/TMP/SMX | Active comparator | TMP/SMZ DS 800 /160 orally every 12 hours for 14 days Receives: Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ) |
| 1C/Doxycycline 100 | Active comparator | Doxycycline 100 mg orally every 12 hours for 56 days Receives: Drug: Cephalexin; Other: Sodium hypochlorite |
| 1D/Doxycycline 20 | Active comparator | Doxycycline 20 mg orally every 12 hours for 56 days Receives: Drug: Doxycycline |
| 2A/Cephalexin + Dilute bleach | Active comparator | Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid Receives: Drug: Cephalexin; Other: Sodium hypochlorite |
| 2B/Cephalexin + Placebo bleach | Placebo comparator | Systemic antibiotics (Cephalexin) + placebo study bath liquid Receives: Drug: Cephalexin; Other: Placebo Sodium hypochlorite |
| 2C/Placebo capsules + Dilute bleach | Placebo comparator | Placebo capsules + dilute bleach study bath liquid Receives: Other: Sodium hypochlorite; Other: Placebo capsules |
| 2D/Placebo capsules + Placebo bleach | Placebo comparator | Placebo capsules + placebo study bath liquid Receives: Other: Placebo capsules; Other: Placebo Sodium hypochlorite |
| 3A/Cephalexin + Dilute bleach | Active comparator | Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid Receives: Drug: Cephalexin; Other: Sodium hypochlorite |
| 3B/Cephalexin + Placebo bleach | Placebo comparator | Systemic antibiotics (Cephalexin) + placebo study bath liquid Receives: Drug: Cephalexin; Other: Placebo Sodium hypochlorite |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize microbiome alterations
Difference in Shannon Diversity Indices (SDI) from baseline to day 14.
Measured: 2 weeks
Secondary outcomes (2)
To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes.
Measured: Throughout the duration of the study
To examine how different antimicrobials may alter the human microbiome.
Measured: Throughout the duration of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
18 Sep 20121 Jan 2027
- First posted29 Jun 2012 (estimated)
- Study start18 Sep 2012
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EczemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Heidi H Kong, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631617
- Sponsor's protocol ID
- 120159
- Other IDs
- 12-AR-0159
- Status last verified
- 22 Oct 2026
- First submitted
- 28 Jun 2012
- Last updated
- 26 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01631617
- Acronym / sponsor ID
- 120159
- Conditions
- Eczema, Dermatitis, Skin Diseases, Genetic, Dermatitis, Atopic, Skin Diseases
- Keywords
- Investigator-Blinded, Skin Biopsy, Randomized, Antibiotics, Topical
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 18 Sep 2012 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| 1A/Cephalexin | Active comparator | Drug: CephalexinCephalexin + Placebo bleach |
| 1B/TMP/SMX | Active comparator | Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)TMP/SMZ DS 800 /160 orally every 12 hours for 14 days |
| 1C/Doxycycline 100 | Active comparator | Drug: Cephalexin, Other: Sodium hypochloriteDoxycycline 100 mg orally every 12 hours for 56 days |
| 1D/Doxycycline 20 | Active comparator | Drug: DoxycyclineDoxycycline 20 mg orally every 12 hours for 56 days |
| 2A/Cephalexin + Dilute bleach | Active comparator | Drug: Cephalexin, Other: Sodium hypochloriteSystemic antibiotics (Cephalexin) + dilute bleach study bath liquid |
| 2B/Cephalexin + Placebo bleach | Placebo comparator | Drug: Cephalexin, Other: Placebo Sodium hypochloriteSystemic antibiotics (Cephalexin) + placebo study bath liquid |
| 2C/Placebo capsules + Dilute bleach | Placebo comparator | Other: Sodium hypochlorite, Other: Placebo capsulesPlacebo capsules + dilute bleach study bath liquid |
| 2D/Placebo capsules + Placebo bleach | Placebo comparator | Other: Placebo capsules, Other: Placebo Sodium hypochloritePlacebo capsules + placebo study bath liquid |
| 3A/Cephalexin + Dilute bleach | Active comparator | Drug: Cephalexin, Other: Sodium hypochloriteSystemic antibiotics (Cephalexin) + dilute bleach study bath liquid |
| 3B/Cephalexin + Placebo bleach | Placebo comparator | Drug: Cephalexin, Other: Placebo Sodium hypochloriteSystemic antibiotics (Cephalexin) + placebo study bath liquid |
Who may qualify
- Ages
- 2 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (23 listed)
- 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
Key exclusion criteria (52 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trimethoprim/sulfamethoxazole (TMP/SMZ)800/160 orally every 12 hours for 14 days | Drug | 1B/TMP/SMX |
| Cephalexin500 mg orally every 8 hours for 14 days | Drug | 1A/Cephalexin, 1C/Doxycycline 100, 2A/Cephalexin + Dilute bleach, 2B/Cephalexin + Placebo bleach, 3A/Cephalexin + Dilute bleach, 3B/Cephalexin + Placebo bleach |
| Doxycycline20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days | Drug | 1D/Doxycycline 20 |
| Sodium hypochlorite6 % dilute bleach | Other | 1C/Doxycycline 100, 2A/Cephalexin + Dilute bleach, 2C/Placebo capsules + Dilute bleach, 3A/Cephalexin + Dilute bleach |
| Placebo capsulesCapsule orally every 8 hours daily for 14 days | Other | 2C/Placebo capsules + Dilute bleach, 2D/Placebo capsules + Placebo bleach |
| Placebo Sodium hypochloriteThree times a week for 14 days | Other | 2B/Cephalexin + Placebo bleach, 2D/Placebo capsules + Placebo bleach, 3B/Cephalexin + Placebo bleach |
Primary outcome
Characterize microbiome alterations
Time frame: 2 weeks
Difference in Shannon Diversity Indices (SDI) from baseline to day 14.
2 secondary outcomes
To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes.
Time frame: Throughout the duration of the study
To examine how different antimicrobials may alter the human microbiome.
Time frame: Throughout the duration of the study
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heidi H Kong, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trimethoprim/sulfamethoxazole (TMP/SMZ), Cephalexin and Doxycycline in people with Eczema and Dermatitis, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi H Kong, M.D. ((301) 827-2460, NIAMSderm@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Characterize microbiome alterations (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.