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Cardamom and Topical Roseomonas for Atopic Dermatitis Relief

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Study AimThis 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-Controlled
Phase 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, 2024Actual 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 enrolledTotal 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.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, and outcome assessors do not know which treatment is being given. This helps reduce bias not just during the study, but also when the results are being evaluated.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 2 to 100 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Dermatitis
Dermatitis, Atopic
Eczema
Exanthema
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Pruritus
Signs and Symptoms
Skin Diseases
Skin Diseases, Genetic
Skin Manifestations
Pathological Conditions, Signs and Symptoms
Skin and Connective Tissue Diseases
Skin Diseases, Eczematous
Genetic 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

Freeze dried packet to be reconstituted in water
Group II
Placebo
Sucrose

Freeze dried packet to be reconstituted in water
Study Objectives
Primary Objectives

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

1\. Proportion of AEs. 2. Proportion of participants using topical steroids over the course of the study.3. Change and percent change in IGA (a measure of eczema rash) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21) and study completion (week 28).4. Change and percent change in NRS (subjective measure of itch) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).5. Change and percent change in SCORAD (a combined metric of eczema itch, rash, QoL) from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).6. Change and percent change in QOL measures, POEM, from baseline (week 0) to: treatment completion (week 14), mid-washout (week 21), and study completion (week 28).

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 CenterBethesda, United StatesSee the location
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One Study Center
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