Cardamom and Topical Roseomonas in Atopic Dermatitis

NCT06096857 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10001677001677-I
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Eczema; Atopic Dermatitis

Keywords

Eczema; Atopic Dermatitis; Roseomonas; Cardamom; Itch; Rash

Outcome Measures

Primary Outcomes (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).

  From Baseline (week 0 to week 28)

Secondary Outcomes (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.

  Week 7 to week 28

Study Arms (2)

Active

ACTIVE COMPARATOR

Roseomonas and Cardamom seeds

Drug: Roseomonas mucosa (RSM2015) and Cardamom seeds

Placebo

PLACEBO COMPARATOR

Sucrose

Drug: Placebo (sucrose)

Interventions

Roseomonas mucosa (RSM2015) and Cardamom seeds DRUG

Freeze dried packet to be reconstituted in water

Active

Placebo (sucrose) DRUG

Freeze dried packet to be reconstituted in water

Placebo

Eligibility Criteria

• Age: 2 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Publications (7)

• 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.

  PMID: 30465329 BACKGROUND

• 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.

  PMID: 34931478 BACKGROUND

• 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.

  PMID: 32908007 BACKGROUND

• 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.

  PMID: 29720571 BACKGROUND

• 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.

  PMID: 33619370 BACKGROUND

• 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.

  PMID: 36877675 BACKGROUND

• 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.

  PMID: 36608129 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus; Exanthema

Interventions

Sucrose

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Ian A Myles, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: October 24, 2023
• Study Start: October 9, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 23, 2026

Record last verified: 2026-01-15

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: Upon publication.
• Access Criteria: Public

Locations

US (1)