NCT01631617

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for phase_2

Timeline
8mo left

Started Sep 2012

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Sep 2012Jan 2027

First Submitted

Initial submission to the registry

June 28, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

September 18, 2012

Completed
14.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

May 4, 2026

Status Verified

April 29, 2026

Enrollment Period

14.3 years

First QC Date

June 28, 2012

Last Update Submit

May 1, 2026

Conditions

Dermatitis, AtopicSkin DiseasesSkin Diseases, GeneticEczemaDermatitis

Keywords

Investigator-BlindedSkin BiopsyRandomizedAntibioticsTopical

Outcome Measures

Primary Outcomes (1)

  • Characterize microbiome alterations

    Difference in Shannon Diversity Indices (SDI) from baseline to day 14.

    2 weeks

Secondary Outcomes (2)

  • 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

Study Arms (10)

1A/Cephalexin

ACTIVE COMPARATOR

Cephalexin + Placebo bleach

Drug: Cephalexin

1B/TMP/SMX

ACTIVE COMPARATOR

TMP/SMZ DS 800 /160 orally every 12 hours for 14 days

Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)

1C/Doxycycline 100

ACTIVE COMPARATOR

Doxycycline 100 mg orally every 12 hours for 56 days

Drug: CephalexinOther: Sodium hypochlorite

1D/Doxycycline 20

ACTIVE COMPARATOR

Doxycycline 20 mg orally every 12 hours for 56 days

Drug: Doxycycline

2A/Cephalexin + Dilute bleach

ACTIVE COMPARATOR

Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid

Drug: CephalexinOther: Sodium hypochlorite

2B/Cephalexin + Placebo bleach

PLACEBO COMPARATOR

Systemic antibiotics (Cephalexin) + placebo study bath liquid

Drug: CephalexinOther: Placebo Sodium hypochlorite

2C/Placebo capsules + Dilute bleach

PLACEBO COMPARATOR

Placebo capsules + dilute bleach study bath liquid

Other: Sodium hypochloriteOther: Placebo capsules

2D/Placebo capsules + Placebo bleach

PLACEBO COMPARATOR

Placebo capsules + placebo study bath liquid

Other: Placebo capsulesOther: Placebo Sodium hypochlorite

3A/Cephalexin + Dilute bleach

ACTIVE COMPARATOR

Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid

Drug: CephalexinOther: Sodium hypochlorite

3B/Cephalexin + Placebo bleach

PLACEBO COMPARATOR

Systemic antibiotics (Cephalexin) + placebo study bath liquid

Drug: CephalexinOther: Placebo Sodium hypochlorite

Interventions

Sodium hypochloriteOTHER

6 % dilute bleach

1C/Doxycycline 1002A/Cephalexin + Dilute bleach2C/Placebo capsules + Dilute bleach3A/Cephalexin + Dilute bleach
Placebo capsulesOTHER

Capsule orally every 8 hours daily for 14 days

2C/Placebo capsules + Dilute bleach2D/Placebo capsules + Placebo bleach
Placebo Sodium hypochloriteOTHER

Three times a week for 14 days

2B/Cephalexin + Placebo bleach2D/Placebo capsules + Placebo bleach3B/Cephalexin + Placebo bleach
Trimethoprim/sulfamethoxazole (TMP/SMZ)DRUG

800/160 orally every 12 hours for 14 days

1B/TMP/SMX
CephalexinDRUG

500 mg orally every 8 hours for 14 days

1A/Cephalexin1C/Doxycycline 1002A/Cephalexin + Dilute bleach2B/Cephalexin + Placebo bleach3A/Cephalexin + Dilute bleach3B/Cephalexin + Placebo bleach
DoxycyclineDRUG

20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days

1D/Doxycycline 20

Eligibility Criteria

Age2 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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
  • +8 more criteria

You may not qualify if:

  • Cohorts 1 \[NO FURTHER ACCRUAL\] and 2 \[INACTIVE\]: Healthy Volunteers
  • 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
  • +33 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

MeSH Terms

Conditions

EczemaDermatitisSkin Diseases, GeneticDermatitis, AtopicSkin Diseases

Interventions

TrimethoprimSulfamethoxazoleCephalexinDoxycyclineSodium Hypochlorite

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBenzenesulfonamidesSulfonamidesAmidesOrganic ChemicalsSulfanilamidesAniline CompoundsAminesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSulfonesSulfur CompoundsCephalosporinsbeta-LactamsLactamsThiazinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsHypochlorous AcidChlorine CompoundsInorganic ChemicalsOxidesOxygen CompoundsSodium Compounds

Study Officials

  • Heidi H Kong, M.D.

    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi H Kong, M.D.

CONTACT

(301) 827-2460NIAMSderm@nih.gov

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 28, 2012

First Posted

June 29, 2012

Study Start

September 18, 2012

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

May 4, 2026

Record last verified: 2026-04-29

Locations

US(1)