Effects of Treatments on Atopic Dermatitis
This study is currently recruiting participants.
Verified March 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )
ClinicalTrials.gov Identifier:
NCT01631617
First received: June 28, 2012
Last updated: May 1, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Dermatitis, Atopic Human Volunteers Eczema Atopic Dermatitis |
Drug: Trimethoprim/sulfamethoxazole Drug: Cephalexin Drug: Doxycycline Other: Sodium hypochlorite (bleach) |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Effects of Treatments on the Microbiome in Healthy Volunteers and Patients With Atopic Dermatitis |
Resource links provided by NLM:
Drug Information available for:
Doxycycline
Sulfamethoxazole
Trimethoprim
Sodium hypochlorite
Cephalexin
Doxycycline monohydrate
Doxycycline Hyclate
Trimethoprim hydrochloride
Doxycycline calcium
Cephalexin hydrochloride
U.S. FDA Resources
Further study details as provided by National Institutes of Health Clinical Center (CC):
Primary Outcome Measures:
- To characterize microbiome alterations in healthy adult volunteers (Cohorts 1 and 2) and pediatric patients with AD and associated active bacterial infection (Cohort 3) after treatment. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes. To examine how different treatments may alter the human microbiome. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 105 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: Trimethoprim/sulfamethoxazole
N/A
Drug: Cephalexin
N/A
Drug: Doxycycline
N/A
Other: Sodium hypochlorite (bleach)
N/A
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 pediatric patients with AD (Cohort 3) after antimicrobial treatments.
Secondary:
- To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes.
- To examine how different antimicrobials may alter the human microbiome.
Eligibility:
- All subjects must be co-enrolled in NIH protocol 08-HG-0059
- (Cohorts 1 and 2) Healthy volunteers aged 18 to 40 years with no history of AD
- (Cohort 1 and 2) No prior use of systemic antibiotics in preceding 12 months
- (Cohort 3) Subjects 2-25 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
Eligibility| Ages Eligible for Study: | 2 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
- INCLUSION CRITERIA:
Cohorts 1 and 2: Healthy Volunteers
Males and females aged 18-40 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 phone and or written informed consent.
Cohort 3: Atopic Dermatitis Patients
- Subjects must be aged 2-25 years.
- Subjects must be co-enrolled in NIH protocol 08-HG-0059
- Subjects must have a diagnosis of atopic dermatitis
- Subjects must have a primary care provider.
- Prior to initiation of treatment, subjects must have signs of bacterial skin infections (skin weeping, crusting, and or pustules).
- 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
- 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.
- History of eczema and asthma.
- Known allergic reaction to certain antibiotics.
- 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.
Cohort 3: Atopic Dermatitis Patients
- Does not meet inclusion criteria.
- Known allergic reaction to certain antibiotics.
- 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.
- Smokers and subjects who use smokeless tobacco products.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01631617
Contacts
| Contact: Heidi H Kong, M.D. | (301) 402-7452 | konghe@mail.nih.gov |
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937 | |
| Contact: Irene Ekwede, B.S.N. (301) 402-6225 irene.ekwede@nih.gov | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Heidi H Kong, M.D. | National Cancer Institute (NCI) |
More Information
Additional Information:
Publications:
| Responsible Party: | National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ) |
| ClinicalTrials.gov Identifier: | NCT01631617 History of Changes |
| Other Study ID Numbers: | 120159, 12-C-0159 |
| Study First Received: | June 28, 2012 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Investigator-Blinded Skin Biopsy Randomized Antibiotics Topical |
Additional relevant MeSH terms:
|
Dermatitis Dermatitis, Atopic Eczema Skin Diseases Skin Diseases, Genetic Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Sodium Hypochlorite Eusol Doxycycline hyclate Cephalexin Doxycycline |
Sulfamethoxazole Trimethoprim Disinfectants Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Anti-Bacterial Agents Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents, Urinary Renal Agents Folic Acid Antagonists Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 23, 2013