Topical treatment for eczema using cardamom and a beneficial bacteria

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

This study is testing a new cream made with cardamom and a helpful bacteria to see if it can improve eczema symptoms in people aged 2 and older.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 2 Years to 100 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Drugs / interventions: Dupilumab, methotrexate
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06096857 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of a topical formulation containing the beneficial bacteria Roseomonas mucosa and ground cardamom seeds for treating atopic dermatitis (eczema) in individuals aged 2 years and older. Participants will apply the treatment 2 to 3 times per week for 14 weeks, followed by a 14-week observation period to assess the longevity of treatment effects. The study aims to evaluate improvements in symptoms such as itch and rash, as well as changes in the skin microbiome. All study visits will be conducted remotely, and participants will receive the treatment product by mail.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 2 years and older with a clinical diagnosis of atopic dermatitis lasting at least 3 months.

Not a fit: Patients with other skin conditions or those who do not meet the eligibility criteria for atopic dermatitis may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate symptoms of atopic dermatitis and improve the quality of life for patients.

How similar studies have performed: While the use of live biotherapeutics in dermatological conditions is an emerging field, similar approaches have shown promise in other studies, suggesting potential for success.

Eligibility 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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Ian A Myles, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
• Study coordinator: Jodi L Blake, R.N.

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