Cardamom and Topical Roseomonas in Atopic Dermatitis
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Atopic Dermatitis, Eczema
In brief
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.
Key facts
- Study ID
- NCT06096857
- Run by
- National Institute of Allergy and Infectious Diseases (NIAID)
- People needed
- 120
- Starts
- 2024-10-09
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: 2 and older, up to 100. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Previous treatment of AD:
- Within 4 weeks prior to the baseline visit with any of the following:
- Immunosuppressive or immunomodulating systemic drugs such as systemic corticosteroids, azathioprine, methotrexate, cyclosporine
- Phototherapy or photochemotherapy for AD
- Within 12 weeks prior to the baseline visit with any of the following having been newly initiated:
- Topical steroids or topical calcineurin inhibitors
- Janus kinase (JAK) inhibitors (oral or topical)
- Dupilumab or any other biologic agent
- Topical PDE4 inhibitor
- Emollients containing ceramides, hyaluronic acid, urea or filaggrin degradation products.
- Bleach baths
- Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit.
- Superficial skin infection requiring topical treatment within 1 week of baseline visit.
- Known or suspected history of immunosuppression or immunodeficiency.
- Existence of indwelling central line.
- Co-habitation with someone that has a known or suspected history of immunosuppression or immunodeficiency or has a central line.
- Any clinically significant laboratory, history, or exam findings that, in the investigator's opinion, would suggest an increased risk to the participant.
- Self-reported pregnancy or breastfeeding.
- Menstruating females who have not menstruated within 6 weeks prior to screening. Participants who have an intrauterine device or implanted long-term contraceptive agent that prevents them from menstruating regularly will not be excluded.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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