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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout the duration of the study
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am a healthy volunteer aged between 18 and 50.
Select...
My eczema is moderate to severe, with a SCORAD score of 15 or more.
Select...
I have been diagnosed with atopic dermatitis.
Select...
I (or my legal representative) can and will follow the study's procedures and have given informed consent.
Select...
I have signs of a bacterial skin infection like weeping, crusting, or pustules.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Characterize microbiome alterations
Secondary outcome measures
To examine how different antimicrobials may alter the human microbiome.
To obtain samples from healthy adult volunteers to evaluate and refine genomic analysis of human microbes.
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
484 Previous Clinical Trials
1,086,877 Total Patients Enrolled
4 Trials studying Eczema
388 Patients Enrolled for Eczema
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am experiencing symptoms or have hormone levels indicating I am in perimenopause.I do not smoke or use smokeless tobacco products.I am between 2 and 50 years old with atopic dermatitis.I haven't used topical corticosteroids on the areas to be tested in the last week.I am not planning to use certain immune or light therapies within 7 days before starting the trial.I haven't taken any antibiotics in the last 8 weeks or applied them on the sampling sites in the last 3 weeks.I have had chemotherapy or radiation for cancer in the last 6 months.I am a healthy volunteer aged between 18 and 50.My eczema is moderate to severe, with a SCORAD score of 15 or more.You have a known allergy or sensitivity to sodium hypochlorite.You have a history of Alzheimer's disease and asthma.I am receiving or planning to receive treatments like immunotherapy or UV light therapy.You work in a healthcare facility or live in a place where healthcare is provided, or you have frequent contact with laboratory animals.I haven't used any complementary or alternative medicine in the last 4 weeks.You have a weakened immune system, either from birth or due to an illness.I have been diagnosed with atopic dermatitis.I have access to facilities for bathing.I (or my legal representative) can and will follow the study's procedures and have given informed consent.I haven't used any alternative medicine in the last 4 weeks.I have signs of a bacterial skin infection like weeping, crusting, or pustules.You are allergic to sodium hypochlorite (NaOCl).My family has a history of severe skin reactions.I haven't been hospitalized for unstable health conditions in the last month.I have not taken antibiotics in the last 12 months.You haven't been in a swimming pool, hot tub, or whirlpool for the past 7 days before the study starts.I have a chronic illness or skin condition like psoriasis.I can swallow pills.You are allergic to beta-lactam class drugs, lidocaine, or epinephrine.You have a weakened immune system, including being HIV positive.You are allergic to certain types of antibiotics or certain numbing medications.
Research Study Groups:
This trial has the following groups:- Group 1: 1C/Doxycycline 100
- Group 2: 3A/Cephalexin + Dilute bleach
- Group 3: 3B/Cephalexin + Placebo bleach
- Group 4: 1A/Cephalexin
- Group 5: 2A/Cephalexin + Dilute bleach
- Group 6: 1B/TMP/SMX
- Group 7: 1D/Doxycycline 20
- Group 8: 2B/Cephalexin + Placebo bleach
- Group 9: 2C/Placebo capsules + Dilute bleach
- Group 10: 2D/Placebo capsules + Placebo bleach
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it possible to become part of this experiment?
"This trial is seeking 130 patients, aged 2 to 50 years old with skin diseases and a genetic disposition."
Answered by AI
What potential hazards are associated with 1B/TMP/SMX?
"Our team at Power rates the safety of 1B/TMP/SMX as a 2, due to its Phase 2 status. Though some evidence exists corroborating its security, there is yet no proof for efficacy."
Answered by AI
Does this research project accept adults of legal age?
"As stated in the trial's criteria for entry, individuals between 2 and 50 years old are eligible to participate."
Answered by AI
What is the total sample size of this clinical trial?
"Affirmative. The information accessible on clinicaltrials.gov confirms that this medical investigation, which was first published on September 18th 2012 is actively recruiting participants. Approximately 130 patients need to be enlisted from 1 different healthcare facility."
Answered by AI
What indications necessitate the utilization of 1B/TMP/SMX?
"1B/TMP/SMX is typically prescribed to treat q fever, though it may also be useful in managing severe acne, bronchitis, and other illnesses."
Answered by AI
Are more individuals being sought to join this research endeavor?
"As indicated by data on clinicaltrials.gov, this study is currently enrolling participants. This trial's first appearance online was September 18th 2012 and the most recent update was November 9th 2022."
Answered by AI
Who else is applying?
What portion of applicants met pre-screening criteria?
Did not meet criteria
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