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Cardamom and Topical Roseomonas for Atopic Dermatitis Relief

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Study Aim

This study aims to evaluate if a combination of topical Roseomonas and ground cardamom seeds can improve symptoms of atopic dermatitis in patients aged 2 and older, by observing improvement in eczema rash after 28 weeks.

What is being tested

Roseomonas mucosa (RSM2015) and Cardamom seeds

+ Placebo (sucrose)

Drug
Who is being recruted

Dermatitis+14

+ Dermatitis, Atopic

+ Eczema

From 2 to 100 Years
+18 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: October 2024
See protocol details

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactJodi L Blake, R.N.More contacts
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: October 9, 2024

Actual date on which the first participant was enrolled.

This clinical trial is designed to explore a new treatment for atopic dermatitis, a common skin condition often characterized by itchy and inflamed skin. The study focuses on a topical treatment combining Roseomonas mucosa, a type of bacteria, with ground cardamom seeds. This treatment is intended for patients aged 2 and older who suffer from atopic dermatitis. The goal is to see if applying this combination to the skin can effectively reduce symptoms and improve overall skin health, even after stopping the treatment. This research could offer a potential new way to manage atopic dermatitis, especially if it shows lasting benefits and reduces the need for steroid creams. Participants in the study will apply the treatment by mixing a dried product with water and putting it on their skin two to three times a week for 14 weeks. After this period, the treatment will stop, and participants will be monitored for another 14 weeks to see how long any benefits last. The study will evaluate improvements in skin symptoms, like itchiness and rash, and will also look at changes in the skin’s bacterial makeup. Additionally, researchers will assess how easy it is for participants to follow the treatment regimen and whether the treatment reduces the need for other medications. Safety and any side effects will also be closely monitored throughout the study.

Official TitleA Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis 
NCT06096857
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactJodi L Blake, R.N.More contacts
Last updated: January 24, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 2 to 100 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

DermatitisDermatitis, AtopicEczemaExanthemaHypersensitivityHypersensitivity, ImmediateImmune System DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesPruritusSigns and SymptomsSkin DiseasesSkin Diseases, GeneticSkin ManifestationsPathological Conditions, Signs and SymptomsSkin and Connective Tissue DiseasesSkin Diseases, EczematousGenetic Diseases, Inborn

Criteria

9 inclusion criteria required to participate
Aged >=2 years

Have a documented primary care provider near residence

Fluency in English (applicable to participant or caregiver who will be answering questionnaires)

EASI >5 and/or an IGA >=1 at time of enrollment.

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9 exclusion criteria prevent from participating
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.

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator
Roseomonas and Cardamom seeds

Group II

Placebo
Sucrose

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

National Institutes of Health Clinical Center

Bethesda, United StatesSee the location
Recruiting
One Study Center