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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

Atopic Dermatitis

+ Eczema
From 2 to 100 Years
How is the trial designed

Treatment Study

Placebo-Controlled
Phase 2
Interventional
Study Start: October 2024

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactJodi L Blake, R.N.
Last updated: August 20, 2025
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 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Study ContactJodi L Blake, R.N.
Last updated: August 20, 2025
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
240 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
Atopic Dermatitis
Eczema
Criteria

* INCLUSION CRITERIA: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Aged \>=2 years 2. Have a documented primary care provider near residence 3. Fluency in English (applicable to participant or caregiver who will be answering questionnaires) 4. 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: * 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 CRITERIA: 1. 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 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.


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

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