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NCT06096857 · National Institute of Allergy and Infectious Diseases (NIAID)

Cardamom and Topical Roseomonas in Atopic Dermatitis

What this study 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.

View original scientific description

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.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • To be eligible to participate in this study, an individual must meet all of the following criteria:
  • Aged \>=2 years
  • Have a documented primary care provider near residence
  • Fluency in English (applicable to participant or caregiver who will be answering questionnaires)
  • Clinical diagnosis of AD, as defined by Hanifin and Rajka criteria, that has been present for \>=3 months before the screening visit
  • Major Criteria: Must have \>=3 basic features:
  • 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:
  • 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
  • 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
  • EASI \>5 and/or an IGA \>=1 at time of enrollment.
  • 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.
  • Participants and parents/legal guardians (for minor participants) are willing and able to comply with all study visits and/or study-related procedures.
  • Participants/parents/guardians must have the ability to provide informed consent/assent as applicable.
  • Willingness to perform visits virtually.

Exclusion criteria

  • 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

  • Bethesda, Maryland

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations

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1 of 120 participants interested
1% interest

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RECRUITING

Bethesda

Maryland

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What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Atopic Dermatitis Treatment Options in Bethesda, Maryland

If you're searching for Atopic Dermatitis treatment in Bethesda, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Bethesda and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Atopic Dermatitis. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Maryland
Now Enrolling
Up to 120 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Atopic Dermatitis?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Atopic Dermatitis

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Atopic Dermatitis Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06096857. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.