Effects of Treatments on Atopic Dermatitis

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    130
  • sponsor
    National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Updated on 30 June 2022
doxycycline
antibiotic therapy
antibiotics
staphylococcus aureus
cephalexin
skin disorder
atopic dermatitis
atopy
eczema
crust
s. aureus
crusting
Accepts healthy volunteers

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.
  • 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.

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.

Details
Condition Eczema, Dermatitis, Skin Diseases, Genetic, Dermatitis, Atopic, Skin Diseases
Treatment doxycycline, Placebo capsules, Cephalexin, Trimethoprim/sulfamethoxazole (TMP/SMZ), Sodium hypochlorite, Sodium hypochlorite, Placebo Sodium hypochlorite
Clinical Study IdentifierNCT01631617
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last Modified on30 June 2022

Eligibility

Yes No Not Sure

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
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
Family history of toxic epidermal necrolysis
Known allergic reaction to sulfa, beta-lactam, or tetracycline class drugs; or
lidocaine or epinephrine
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
Cohort 3: Atopic Dermatitis Patients
psoriasis
Any female with symptoms and/or serum hormone levels consistent with perimenopause
Subjects receiving or planning to receive an IND agent, ultraviolet light therapy
Known allergic reaction to beta-lactam class drugs, lidocaine, or epinephrine
monoclonal antibodies, or systemic immunosuppressants
Family history of toxic epidermal necrolysis
Subjects who provide direct healthcare or reside in healthcare facilities or in
non-hospital settings such as clinics, assisted living facilities, homeless shelters
Known allergic reaction to sodium hypochlorite (NaOCl)
jails and prisons as well as subjects with frequent exposure to laboratory animals
Use of topical or oral CAM agents within 4 weeks of initiation of treatment
Subjects with known primary or acquired immunodeficiency
Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended
Pregnancy or lactating
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
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
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
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