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)

Send

Updated on 30 June 2022

See if I qualify

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 Identifier	NCT01631617
Sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Last Modified on	30 June 2022

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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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Effects of Treatments on Atopic Dermatitis