- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01631617
Effects of Treatments on Atopic Dermatitis
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.
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.
- This study will last for up to 1 year. 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.
Study Overview
Status
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 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.
OBJECTIVES:
Primary:
-To characterize microbiome alterations in healthy adult volunteers (Cohorts 1 and 2) and patients with AD (Cohort 3) after antimicrobial treatments.
ELIGIBILITY:
- All subjects must be co-enrolled in NIH protocol 08-HG-0059
- (Cohorts 1 and 2) Healthy volunteers aged 18 to 50 years with no history of AD
- (Cohort 1 and 2) No prior use of systemic antibiotics in preceding 12 months
- (Cohort 3) Subjects 2-50 years with atopic dermatitis with symptoms of active bacterial infection
- (Cohort 3) Objective SCORAD (SCORing Atopic Dermatitis) score of greater than or equal to 15 indicating moderate-to-severe disease
DESIGN:
- A prospective, interventional, longitudinal study examining changes in microbiome resulting from randomized, placebo-controlled, investigator-blinded antimicrobial treatments.
- Subjects in Cohort 1 will be randomized to take one of 4 open label antibiotic regimens.
- Subjects from Cohort 2 will be will be randomized to one of four possible blinded treatment combinations of study baths and antibiotics.
- Subjects in Cohort 3 will be randomized to a cephalexin regimen with or without study baths.
- All subjects will undergo longitudinal microbiome sampling.
- AD patients will undergo clinical assessment to determine responses of skin infections to treatment.
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Heidi H Kong, M.D.
- Phone Number: (301) 827-2460
- Email: konghe@mail.nih.gov
Study Contact Backup
- Name: Monica Taylor, R.N.
- Phone Number: (301) 451-2221
- Email: monica.taylor@nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- Recruiting
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Phone Number: TTY8664111010 800-411-1222
- Email: prpl@cc.nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- INCLUSION CRITERIA:
Cohorts 1 and 2: Healthy Volunteers
Males and females aged 18-50 years.
- 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
- Ability to swallow capsules or tablets
Cohort 3: 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.
EXCLUSION CRITERIA:
Cohorts 1 and 2: Healthy Volunteers
- Does not meet inclusion criteria
- Any female with symptoms and/or serum hormone levels consistent with perimenopause
- 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 and 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 clinics, assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals
Cohort 3: Atopic Dermatitis Patients
- Does not meet inclusion criteria
- Any female with symptoms and/or serum hormone levels consistent with perimenopause
- 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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 1A/Cephalexin
Cephalexin + Placebo bleach
|
500 mg orally every 8 hours for 14 days
|
Active Comparator: 1B/TMP/SMX
TMP/SMZ DS 800 /160 orally every 12 hours for 14 days
|
800/160 orally every 12 hours for 14 days
|
Active Comparator: 1C/Doxycycline 100
Doxycycline 100 mg orally every 12 hours for 56 days
|
500 mg orally every 8 hours for 14 days
6 % dilute bleach
|
Active Comparator: 1D/Doxycycline 20
Doxycycline 20 mg orally every 12 hours for 56 days
|
20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days
|
Active Comparator: 2A/Cephalexin + Dilute bleach
Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
|
500 mg orally every 8 hours for 14 days
6 % dilute bleach
|
Placebo Comparator: 2B/Cephalexin + Placebo bleach
Systemic antibiotics (Cephalexin) + placebo study bath liquid
|
500 mg orally every 8 hours for 14 days
Three times a week for 14 days
|
Placebo Comparator: 2C/Placebo capsules + Dilute bleach
Placebo capsules + dilute bleach study bath liquid
|
6 % dilute bleach
Capsule orally every 8 hours daily for 14 days
|
Placebo Comparator: 2D/Placebo capsules + Placebo bleach
Placebo capsules + placebo study bath liquid
|
Three times a week for 14 days
Capsule orally every 8 hours daily for 14 days
|
Active Comparator: 3A/Cephalexin + Dilute bleach
Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
|
500 mg orally every 8 hours for 14 days
6 % dilute bleach
|
Placebo Comparator: 3B/Cephalexin + Placebo bleach
Systemic antibiotics (Cephalexin) + placebo study bath liquid
|
500 mg orally every 8 hours for 14 days
Three times a week for 14 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Characterize microbiome alterations
Time Frame: 2 weeks
|
Difference in Shannon Diversity Indices (SDI) from baseline to day 14.
|
2 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes.
Time Frame: Throughout the duration of the study
|
Throughout the duration of the study
|
To examine how different antimicrobials may alter the human microbiome.
Time Frame: Throughout the duration of the study
|
Throughout the duration of the study
|
Collaborators and Investigators
Investigators
- Principal Investigator: Heidi H Kong, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Hypersensitivity, Immediate
- Hypersensitivity
- Skin Diseases, Eczematous
- Dermatitis
- Skin Diseases
- Dermatitis, Atopic
- Genetic Diseases, Inborn
- Skin Diseases, Genetic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antiprotozoal Agents
- Antiparasitic Agents
- Antimalarials
- Folic Acid Antagonists
- Disinfectants
- Anti-Dyskinesia Agents
- Anti-Infective Agents, Urinary
- Cytochrome P-450 CYP2C8 Inhibitors
- Doxycycline
- Cephalexin
- Trimethoprim
- Sulfamethoxazole
- Sodium Hypochlorite
- Eusol
Other Study ID Numbers
- 120159
- 12-AR-0159
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Skin Diseases
-
R2 DermatologyCompleted
-
TCI Co., Ltd.Completed
-
Access Business GroupClinical Research LaboratoriesCompleted
-
West Virginia UniversityMary Babb Randolph Cancer Center at West Virginia University Hospitals; West...RecruitingSkin Cancer | Skin Lesion | Skin Melanoma | Tumor SkinUnited States
-
R2 DermatologyRecruitingSkin LesionUnited States
-
TCI Co., Ltd.Completed
Clinical Trials on Cephalexin
-
BayerCorporación Bonima S.A. de C.V.CompletedAnti-Infective AgentsMexico
-
Ottawa Hospital Research InstituteThe Ottawa Hospital Academic Medical Association; Network of Canadian Emergency...Recruiting
-
BayerCorporación Bonima S.A. de C.V.CompletedAnti-Infective AgentsMexico
-
BayerCorporación Bonima S.A. de C.V.CompletedAnti-Infective AgentsMexico
-
University of California, San FranciscoCompletedSoft Tissue InfectionsUnited States
-
Brett A FaineUniversity of California, Los AngelesNot yet recruitingPyelonephritis Acute
-
University of PennsylvaniaTerminatedThrough-and-through Lip LacerationsUnited States
-
AbbottCompletedMild to Moderate Uncomplicated Skin and Skin Structure Infections
-
Aga Khan UniversityDow University of Health Sciences; Liaquat National Hospital & Medical CollegeUnknownSurgical Site InfectionPakistan
-
University of MichiganRecruitingFacial DefectUnited States