Cardamom and Topical Roseomonas for Atopic Dermatitis (Eczema)

This study is testing a new topical treatment for atopic dermatitis (AD), also known as eczema. Researchers want to see if a combination of Roseomonas mucosa (a type of bacteria) and ground cardamom seeds can improve AD symptoms. They believe that people with AD have different bacteria on their skin, and adding Roseomonas mucosa might help. You could be eligible if you are 2 years or older and have AD. The main goal is to see if this treatment improves symptoms 14 weeks after you stop using it. The study is currently unclear on its recruitment status, but plans to enroll 120 participants.

Study design
This is a double-blind, randomized study, meaning neither you nor the study team will know if you are receiving the active treatment (Roseomonas mucosa and cardamom) or a placebo (sucrose). It is a Phase 2b trial and plans to enroll 120 participants.
What's involved
You will have 5 remote visits over about 7 months. You will apply the study product to your skin 2 or 3 times per week for 14 weeks.
Compensation
Not stated in the trial record.
Follow-up
After 14 weeks of treatment, you will be followed for an additional 14 weeks to see how long the treatment effects last.

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NCT06096857

Cardamom and Topical Roseomonas in Atopic Dermatitis

Recruiting
PHASE2Ages 2+InterventionalTreatment
National Institute of Allergy and Infectious Diseases (NIAID)
~120 participants
Updated 2026-08-13 on ClinicalTrials.gov
What's tested:Roseomonas mucosa (RSM2015) and Cardamom seedsPlacebo (sucrose)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To determine if R mucosa combined with ground cardamom seeds can improve symptoms of AD in patients aged 2 and older, 14 weeks after treatment discontinuation.
Measured over From Baseline (week 0 to week 28)
Atopic Dermatitis
Eczema
1 sites across 1 states
Maryland1
  • Ian A Myles, M.D. · PRINCIPAL_INVESTIGATOR · National Institute of Allergy and Infectious Diseases (NIAID)

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Eligibility criteria

Inclusion

Major Criteria: Must have \>=3 basic features:
Pruritus
Typical morphology and distribution (flexural lichenification in adults, facial and extensor eruptions in infants and children)
Chronic or chronically relapsing dermatitis
Personal or family history of atopy (asthma, allergic rhinitis, AD)
Minor Criteria: Must have \>=3 minor features:
Xerosis
Ichthyosis/palmar hyperlinearity, keratosis pilaris
Immediate (type 1) skin-test reactivity
Raised serum IgE
Early age of onset
Tendency toward cutaneous infections (especially Staphylococcus aureus and herpes simplex), impaired cell-mediated immunity
Tendency toward non-specific hand or foot dermatitis
Nipple eczema
Cheilitis
Recurrent conjunctivitis
Dennie-Morgan infraorbital fold
Keratoconus
Anterior subcapsular cataracts
Orbital darkening
Facial pallor, facial erythema
Pityriasis alba
Anterior neck folds
Itch when sweating
Intolerance to wool and lipid solvents
Perifollicular accentuation
Food intolerance
Course influenced by environmental or emotional factors
White dermographism, delayed blanch 5. EASI \>5 and/or an IGA \>=1 at time of enrollment. 6. Sexually active participants of childbearing potential must agree to use adequate methods of contraception from the screening visit continuously until 30 days after stopping treatment with the investigational product. Childbearing potential is defined for children as participants who have begun menstruating and for adults as participants who are not surgically sterile (hysterectomy and/or tubal ligation) or menopausal (age \>=45 years plus no menses for 12 consecutive months without an alternative medical cause). Adequate contraception methods include: a barrier method (eg, condom use), oral contraceptive pill, hormonal patch or ring, hormonal injection, parenteral hormonal implant, or an intrauterine device. 7. Participants and parents/legal guardians (for minor participants) are willing and able to comply with all study visits and/or study-related procedures. 8. Participants/parents/guardians must have the ability to provide informed consent/assent as applicable. 9. Willingness to perform visits virtually.

Exclusion

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 2. Active infection (chronic or acute) requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the baseline visit. 3. Superficial skin infection requiring topical treatment within 1 week of baseline visit. 4. Known or suspected history of immunosuppression or immunodeficiency. 5. Existence of indwelling central line. 6. Co-habitation with someone that has a known or suspected history of immunosuppression or immunodeficiency or has a central line. 7. Any clinically significant laboratory, history, or exam findings that, in the investigator's opinion, would suggest an increased risk to the participant. 8. Self-reported pregnancy or breastfeeding. 9. 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.
  • To determine if R mucosa combined with ground cardamom seeds can improve symptoms of AD in patients aged 2 and older, 14 weeks after treatment discontinuation.From Baseline (week 0 to week 28)

    Proportion of participants achieving a 90% improvement in EASI90 (a measure of eczema rash) from baseline (week 0) to study completion (week 28).