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Atopic DermatitisPhase 2NCT06096857

Cardamom and Topical Roseomonas in Atopic Dermatitis

A Phase 2 study testing Roseomonas mucosa (RSM2015) and Cardamom seeds in people with Atopic Dermatitis and Eczema, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 2 to 100 years
Conditions the study is for
Atopic Dermatitis, Eczema
What is being tested?
Roseomonas mucosa (RSM2015) and Cardamom seeds
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
9 Oct 2024to 1 Jan 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 100 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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:
Show all 39Show fewer
  • 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
  • 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.

Who cannot join

  • 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
Show all 19Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jodi L Blake, R.N. contact

(301) 605-2896

jodi.blake@nih.gov

Ian A Myles, M.D. contact

(301) 451-8420

mylesi@niaid.nih.gov

United States1 site, 1 recruiting

  • National Institutes of Health Clinical Center

    Bethesda, Maryland, 20892

    NIH Clinical Center Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY dial 711, ccopr@nih.gov

    Recruiting

Other trials in United States

About this study

Official title: A Phase 2b, Double-Blind, Randomized, Placebo-Controlled Trial of Cardamom and Topical Roseomonas in Atopic Dermatitis

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.

Read more

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.

Read the detailed description

Study Description:

This is a double-blind, randomized, phase 2b clinical trial for a topical formulation of a live biotherapeutic containing Roseomonas mucosa combined with ground cardamom seeds in a sucrose solution for patients with atopic dermatitis (AD). Participants will reconstitute the dried product in water and apply topically 2 or 3 times per week for 14 weeks. After 14 weeks, all interventions will cease, and participants will be followed for an additional 14 weeks to assess how long treatment effects last. During the course of study, we will assess disease severity (eg, itch, rash, and quality of life [QOL]) using a variety of AD assessments, ease of compliance with treatment, and changes in the microbiome profile of the skin. We hypothesize that topical treatment with Roseomonas mucosa, combined with ground cardamom seeds, will provide significantly more alleviation in AD symptoms than placebo, and that these effects will last beyond active treatment (due to the ability of the bacteria to colonize the patients' skin).

Primary Objective:

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.

Secondary Objective:

  1. To determine if R mucosa combined with ground cardamom seeds can improve the Investigator s Global Assessment (IGA) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion.
  2. To determine if R mucosa combined with ground cardamom seeds can improve the Numerical Rating Scale (NRS; both for average and worse severity over the 2-3 weeks prior to assessment) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion.
  3. To determine if R mucosa combined with ground cardamom seeds can improve the SCORing Atopic Dermatitis (SCORAD) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion.
  4. To determine if R mucosa combined with ground cardamom seeds can improve the Patient-Oriented Eczema Measure (POEM) in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation, and at study completion.
  5. To determine if effects of R mucosa combined with ground cardamom seeds on the symptoms of AD differ by levels of pollution near home of residence.
  6. To determine if use of R mucosa permits less use of topical steroid treatments.
  7. To determine the safety of R mucosa use.

Exploratory Objectives:

  1. To determine if patients and caregivers using topical R mucosa understand the instructions and precautions for use.
  2. To determine if topical R mucosa with cardamom seeds alters the skin microbiome profile during and after treatment.
  3. To determine if topical R mucosa colonizes the skin of patients during use.

Primary Endpoint:

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

Secondary Endpoints:

  1. Proportion of adverse events (AEs).
  2. Mean number of average weekly topical steroid use over the study follow up.
  3. Change and percent change in IGA (a measure of eczema rash) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
  4. Change and percent change in EASI (a measure of eczema rash) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
  5. Change and percent change in NRS (subjective measure of itch) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
  6. Change and percent change in SCORAD (a combined metric of eczema itch, rash, QOL) from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
  7. Change and percent change in QOL measures, POEM, from baseline (week 0) to: treatment completion (week 14), mid-follow-up (week 21), and study completion (week 28).
  8. Association between improvement in EASI (a measure of eczema rash) from baseline (week 0) to study completion (week 28) and residence in high-pollution areas versus low-pollution areas.

Exploratory Endpoints:

  1. Accuracy of identifying correct answers to questions about product applications and precautions.
  2. Qualitative input regarding ease of use of product.
  3. Presence of treatment strain of R mucosa as assessed by genetic detection (using polymerase chain reaction [PCR] primer).
  4. Change in skin microbiome profile during and after treatment.
Being tested
Roseomonas mucosa (RSM2015) and Cardamom seeds, Placebo (sucrose)
Keywords
Eczema, Atopic Dermatitis, Roseomonas, Cardamom, Itch, Rash
Medical subject headings
Dermatitis, Atopic, Eczema, Pruritus, Exanthema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roseomonas mucosa (RSM2015) and Cardamom seedsDrug

    Freeze dried packet to be reconstituted in water

  • Placebo (sucrose)Drug

    Freeze dried packet to be reconstituted in water

Study groups in NCT06096857
Study groupRoleWhat they receive
ActiveActive comparatorRoseomonas and Cardamom seeds
Receives: Drug: Roseomonas mucosa (RSM2015) and Cardamom seeds
PlaceboPlacebo comparatorSucrose
Receives: Drug: Placebo (sucrose)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

    Measured: From Baseline (week 0 to week 28)

Secondary outcomes (1)

  1. To determine if R mucosa combined with ground cardamom seeds can improve symptoms of AD in patients aged 2 and older, during active treatment as well as 7 weeks after treatment discontinuation.

    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).

    Measured: Week 7 to week 28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Oct 2023
  2. Study start9 Oct 2024
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06096857
Sponsor's protocol ID
10001677
Other IDs
001677-I
Status last verified
28 Oct 2026
First submitted
21 Oct 2023
Last updated
30 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All clinical data will be striped of PII and included in the publication. All microbiome data will be deposited in the appropriate databases.

Publications

  • Li L, Han Z, Niu X, Zhang G, Jia Y, Zhang S, He C. Probiotic Supplementation for Prevention of Atopic Dermatitis in Infants and Children: A Systematic Review and Meta-analysis. Am J Clin Dermatol. 2019 Jun;20(3):367-377. doi: 10.1007/s40257-018-0404-3.

    PubMed 30465329

  • Mashiah J, Karady T, Fliss-Isakov N, Sprecher E, Slodownik D, Artzi O, Samuelov L, Ellenbogen E, Godneva A, Segal E, Maharshak N. Clinical efficacy of fecal microbial transplantation treatment in adults with moderate-to-severe atopic dermatitis. Immun Inflamm Dis. 2022 Mar;10(3):e570. doi: 10.1002/iid3.570. Epub 2021 Dec 20.

    PubMed 34931478

  • Myles IA, Castillo CR, Barbian KD, Kanakabandi K, Virtaneva K, Fitzmeyer E, Paneru M, Otaizo-Carrasquero F, Myers TG, Markowitz TE, Moore IN, Liu X, Ferrer M, Sakamachi Y, Garantziotis S, Swamydas M, Lionakis MS, Anderson ED, Earland NJ, Ganesan S, Sun AA, Bergerson JRE, Silverman RA, Petersen M, Martens CA, Datta SK. Therapeutic responses to Roseomonas mucosa in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair. Sci Transl Med. 2020 Sep 9;12(560):eaaz8631. doi: 10.1126/scitranslmed.aaz8631.

    PubMed 32908007

  • Myles IA, Earland NJ, Anderson ED, Moore IN, Kieh MD, Williams KW, Saleem A, Fontecilla NM, Welch PA, Darnell DA, Barnhart LA, Sun AA, Uzel G, Datta SK. First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. JCI Insight. 2018 May 3;3(9):e120608. doi: 10.1172/jci.insight.120608.

    PubMed 29720571

  • Nakatsuji T, Hata TR, Tong Y, Cheng JY, Shafiq F, Butcher AM, Salem SS, Brinton SL, Rudman Spergel AK, Johnson K, Jepson B, Calatroni A, David G, Ramirez-Gama M, Taylor P, Leung DYM, Gallo RL. Development of a human skin commensal microbe for bacteriotherapy of atopic dermatitis and use in a phase 1 randomized clinical trial. Nat Med. 2021 Apr;27(4):700-709. doi: 10.1038/s41591-021-01256-2. Epub 2021 Feb 22.

    PubMed 33619370

  • Yadav M, Chaudhary PP, D'Souza BN, Ratley G, Spathies J, Ganesan S, Zeldin J, Myles IA. Diisocyanates influence models of atopic dermatitis through direct activation of TRPA1. PLoS One. 2023 Mar 6;18(3):e0282569. doi: 10.1371/journal.pone.0282569. eCollection 2023.

    PubMed 36877675

  • Zeldin J, Chaudhary PP, Spathies J, Yadav M, D'Souza BN, Alishahedani ME, Gough P, Matriz J, Ghio AJ, Li Y, Sun AA, Eichenfield LF, Simpson EL, Myles IA. Exposure to isocyanates predicts atopic dermatitis prevalence and disrupts therapeutic pathways in commensal bacteria. Sci Adv. 2023 Jan 6;9(1):eade8898. doi: 10.1126/sciadv.ade8898. Epub 2023 Jan 6.

    PubMed 36608129

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Roseomonas mucosa (RSM2015) and Cardamom seeds in people with Atopic Dermatitis and Eczema, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 39 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jodi L Blake, R.N. ((301) 605-2896, jodi.blake@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: From Baseline (week 0 to week 28)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06096857, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.

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