Actively Recruiting
Cardamom and Topical Roseomonas in Atopic Dermatitis
Led by National Institute of Allergy and Infectious Diseases (NIAID) · Updated on 2026-01-23
120
Participants Needed
1
Research Sites
116 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cardamom and Topical Roseomonas in Atopic Dermatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 2 years or older
- Have a primary care provider near their residence
- Fluent in English (participant or caregiver)
- Clinical diagnosis of atopic dermatitis present for 3 months or more before screening
- Meet Hanifin and Rajka criteria for AD, including at least 3 major and 3 minor features
- Eczema Area and Severity Index (EASI) score greater than 5 and/or Investigator's Global Assessment (IGA) score of 1 or higher at enrollment
- Sexually active participants of childbearing potential agree to use adequate contraception during and 30 days after treatment
- Willing and able to comply with all study visits and procedures
- Ability to provide informed consent or assent
- Willingness to complete visits virtually
You will not qualify if you...
- Use of immunosuppressive or immunomodulating systemic drugs or phototherapy for AD within 4 weeks before baseline
- Starting new topical steroids, calcineurin inhibitors, JAK inhibitors, biologics, PDE4 inhibitors, or certain emollients within 12 weeks before baseline
- Active infection requiring systemic antibiotics, antivirals, or antifungals within 2 weeks before baseline
- Superficial skin infection needing topical treatment within 1 week before baseline
- Known or suspected immunosuppression or immunodeficiency
- Having an indwelling central line
- Living with someone who has immunosuppression or an indwelling central line
- Any significant lab, medical history, or exam findings posing increased risk
- Pregnancy or breastfeeding
- Menstruating females who have not menstruated within 6 weeks before screening unless using long-term contraceptive devices
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
J
Jodi L Blake, R.N.
CONTACT
I
Ian A Myles, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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