Topical Bacteria + Cardamom for Eczema
Trial Summary
What is the purpose of this trial?
Background: Atopic dermatitis (AD), also called eczema, is a chronic skin condition. AD can make skin dry and itchy, and sometimes it can lead to serious health problems, such as asthma, food allergies, eye infections, and sleep problems. No cure exists for AD. Researchers know that people with AD have different kinds of harmless bacteria on their skin than do people without AD. They want to see if adding a harmless bacteria (Roseomonas mucosa) to the skin can help people with AD. Objective: To test a skin treatment that contains R. mucosa and ground cardamom seeds in people with AD. Eligibility: People aged 2 years and older with AD. Design: All study visits will be remote. Participants will have 5 visits over about 7 months. Participants will be screened. Researchers will review their AD and medical history. Participants will receive a study product in the mail. The product comes as a powder in single-use packets. Participants will be shown how to mix the powder with water in a single-use spray vial. They will spray the solution onto their skin 2 to 3 times per week for 14 weeks. Half of participants will receive the study powder. Half will receive a placebo; the placebo looks just like the study powder but contains no bacteria. They will not know which one they have. During 3 study visits, participants will take a skin swab. They will receive supplies in the mail to rub a cotton swab on their skin and mail it back to the researchers. Participants may opt to have pictures taken of their AD. Participants will fill out 4 online questionnaires.
Will I have to stop taking my current medications?
The trial requires that you stop certain medications before starting. You must not have used immunosuppressive drugs, phototherapy, or certain topical treatments for a specified period before the trial begins. Check with the trial team to see if your current medications are affected.
What evidence supports the effectiveness of the treatment using Topical Bacteria + Cardamom for Eczema?
Is the combination of topical bacteria and cardamom safe for treating eczema?
How does the treatment with Topical Bacteria + Cardamom for Eczema differ from other treatments?
This treatment is unique because it uses a combination of Roseomonas mucosa, a beneficial skin bacterium, and cardamom, which may help improve skin health by restoring the natural balance of skin bacteria and reducing harmful bacteria like Staphylococcus aureus. Unlike traditional treatments that often rely on steroids, this approach targets the skin's microbiome to enhance the skin barrier and reduce inflammation.610111213
Research Team
Ian A Myles, M.D.
Principal Investigator
National Institute of Allergy and Infectious Diseases (NIAID)
Eligibility Criteria
This trial is for people aged 2 years and older with atopic dermatitis (AD), also known as eczema. Participants must be willing to do virtual visits, speak English, have a primary care provider nearby, and use contraception if of childbearing potential. They should not have used certain AD treatments recently or have infections needing systemic treatment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study product, applying it topically 2-3 times per week for 14 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Cardamom seeds
- Placebo (sucrose)
- Roseomonas mucosa
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute of Allergy and Infectious Diseases (NIAID)
Lead Sponsor