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Antibiotic

Antibiotics and Bleach Baths for Eczema

Phase 2
Recruiting
Led By Heidi H Kong, M.D.
Research Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Cohorts 1 and 2: Healthy Volunteers - Males and females aged 18-50 years
Subjects must have an Objective SCORAD (SCORing Atopic Dermatitis) of greater than or equal to 15 indicating AD severity of moderate to severe
Must not have
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.
Use of systemic antibiotics within 8 weeks, or topical antibiotics on intended sampling sites within 3 weeks, prior to baseline sampling
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 weeks

Summary

This trial is studying how eczema treatments affect the number and type of bacteria on the skin.

Who is the study for?
This trial is for people aged 2-50 with moderate to severe atopic dermatitis, and healthy volunteers aged 18-40. Participants need access to bathing facilities, must not have used certain medications recently, and should not be pregnant or lactating. Smokers and those with a history of serious allergies or immune deficiencies are excluded.
What is being tested?
The study examines the effects of antibiotics (TMP/SMZ, Cephalexin, Doxycycline) and Sodium hypochlorite compared to placebos on skin bacteria in eczema patients over one year. It involves regular visits for sample collection and possibly skin biopsies.
What are the potential side effects?
Potential side effects may include allergic reactions to the antibiotics such as rash or digestive issues; sensitivity reactions from Sodium hypochlorite like skin irritation; plus general medication-related risks like nausea or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a healthy volunteer aged between 18 and 50.
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My eczema is moderate to severe, with a SCORAD score of 15 or more.
Select...
I have been diagnosed with atopic dermatitis.
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I (or my legal representative) can and will follow the study's procedures and have given informed consent.
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I have signs of a bacterial skin infection like weeping, crusting, or pustules.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not smoke or use smokeless tobacco products.
Select...
I haven't taken any antibiotics in the last 8 weeks or applied them on the sampling sites in the last 3 weeks.
Select...
I am receiving or planning to receive treatments like immunotherapy or UV light therapy.
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My family has a history of severe skin reactions.
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I haven't been hospitalized for unstable health conditions in the last month.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Characterize microbiome alterations

Trial Design

10Treatment groups
Active Control
Placebo Group
Group I: 1C/Doxycycline 100Active Control2 Interventions
Doxycycline 100 mg orally every 12 hours for 56 days
Group II: 3A/Cephalexin + Dilute bleachActive Control2 Interventions
Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
Group III: 1A/CephalexinActive Control1 Intervention
Cephalexin + Placebo bleach
Group IV: 2A/Cephalexin + Dilute bleachActive Control2 Interventions
Systemic antibiotics (Cephalexin) + dilute bleach study bath liquid
Group V: 1B/TMP/SMXActive Control1 Intervention
TMP/SMZ DS 800 /160 orally every 12 hours for 14 days
Group VI: 1D/Doxycycline 20Active Control1 Intervention
Doxycycline 20 mg orally every 12 hours for 56 days
Group VII: 3B/Cephalexin + Placebo bleachPlacebo Group2 Interventions
Systemic antibiotics (Cephalexin) + placebo study bath liquid
Group VIII: 2B/Cephalexin + Placebo bleachPlacebo Group2 Interventions
Systemic antibiotics (Cephalexin) + placebo study bath liquid
Group IX: 2C/Placebo capsules + Dilute bleachPlacebo Group2 Interventions
Placebo capsules + dilute bleach study bath liquid
Group X: 2D/Placebo capsules + Placebo bleachPlacebo Group2 Interventions
Placebo capsules + placebo study bath liquid

Find a Location

Who is running the clinical trial?

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)Lead Sponsor
496 Previous Clinical Trials
1,089,382 Total Patients Enrolled
Heidi H Kong, M.D.Principal InvestigatorNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
4 Previous Clinical Trials
1,072 Total Patients Enrolled

Media Library

Cephalexin (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT01631617 — Phase 2
Atopic Dermatitis Research Study Groups: 1C/Doxycycline 100, 3A/Cephalexin + Dilute bleach, 3B/Cephalexin + Placebo bleach, 1A/Cephalexin, 2A/Cephalexin + Dilute bleach, 1B/TMP/SMX, 1D/Doxycycline 20, 2B/Cephalexin + Placebo bleach, 2C/Placebo capsules + Dilute bleach, 2D/Placebo capsules + Placebo bleach
Atopic Dermatitis Clinical Trial 2023: Cephalexin Highlights & Side Effects. Trial Name: NCT01631617 — Phase 2
Cephalexin (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01631617 — Phase 2
~19 spots leftby Jan 2027
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