Effects of Treatments on Atopic Dermatitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age2-50
SponsorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Does not meet inclusion criteria
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
Trial design
Design model
Parallel
Treatments tested in this trial
Trimethoprim/sulfamethoxazole (TMP/SMZ)
Drug800/160 orally every 12 hours for 14 days
Cephalexin
Drug500 mg orally every 8 hours for 14 days
Doxycycline
Drug20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days
Sodium hypochlorite
Other intervention6 % dilute bleach
Placebo capsules
Other interventionCapsule orally every 8 hours daily for 14 days
Placebo Sodium hypochlorite
Other interventionThree times a week for 14 days
Treatment groups
130 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: 1A/CephalexinActive comparator 1 intervention
Group B: 1B/TMP/SMXActive comparator 1 intervention
Group C: 1C/Doxycycline 100Active comparator 2 interventions
Group D: 1D/Doxycycline 20Active comparator 1 intervention
Group E: 2A/Cephalexin + Dilute bleachActive comparator 2 interventions
Group F: 2B/Cephalexin + Placebo bleachPlacebo comparator 2 interventions
Group G: 2C/Placebo capsules + Dilute bleachPlacebo comparator 2 interventions
Group H: 2D/Placebo capsules + Placebo bleachPlacebo comparator 2 interventions
Group I: 3A/Cephalexin + Dilute bleachActive comparator 2 interventions
Group J: 3B/Cephalexin + Placebo bleachPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
Characterize microbiome alterations
Difference in Shannon Diversity Indices (SDI) from baseline to day 14.
Time frame
2 weeksSecondary outcomes
1
To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes.
Time frame
Throughout the duration of the study2
To examine how different antimicrobials may alter the human microbiome.
Time frame
Throughout the duration of the studySponsors and contacts
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Source ClinicalTrials.gov