240 Participants Needed

Topical Bacteria + Cardamom for Eczema

AA
IA
Overseen ByIan A Myles, M.D.
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you stop certain medications before starting. You must not have used immunosuppressive drugs, phototherapy, or certain topical treatments for a specified period before the trial begins. Check with the trial team to see if your current medications are affected.

What evidence supports the effectiveness of the treatment using Topical Bacteria + Cardamom for Eczema?

Research on other botanical treatments, like chamomile and Mahonia aquifolium, shows they can help with eczema by reducing inflammation and improving skin condition. This suggests that natural ingredients, like cardamom, might also be beneficial for eczema.12345

Is the combination of topical bacteria and cardamom safe for treating eczema?

Cardamom has been shown to have anti-inflammatory properties and did not show toxicity in cell studies, but there is a case of allergic skin reaction to cardamom in one person. This suggests that while generally safe, some individuals may experience allergic reactions.56789

How does the treatment with Topical Bacteria + Cardamom for Eczema differ from other treatments?

This treatment is unique because it uses a combination of Roseomonas mucosa, a beneficial skin bacterium, and cardamom, which may help improve skin health by restoring the natural balance of skin bacteria and reducing harmful bacteria like Staphylococcus aureus. Unlike traditional treatments that often rely on steroids, this approach targets the skin's microbiome to enhance the skin barrier and reduce inflammation.610111213

Research Team

IA

Ian A Myles, M.D.

Principal Investigator

National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria

This trial is for people aged 2 years and older with atopic dermatitis (AD), also known as eczema. Participants must be willing to do virtual visits, speak English, have a primary care provider nearby, and use contraception if of childbearing potential. They should not have used certain AD treatments recently or have infections needing systemic treatment.

Inclusion Criteria

Have a documented primary care provider near residence
Fluency in English (applicable to participant or caregiver who will be answering questionnaires)
I have been diagnosed with atopic dermatitis for at least 3 months.
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Exclusion Criteria

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.
I haven't used certain immune-affecting drugs or light therapy for my skin condition in the last 4 weeks.
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (remote)

Treatment

Participants receive the study product, applying it topically 2-3 times per week for 14 weeks

14 weeks
3 visits (remote)

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 weeks
1 visit (remote)

Treatment Details

Interventions

  • Cardamom seeds
  • Placebo (sucrose)
  • Roseomonas mucosa
Trial OverviewThe study tests a skin treatment combining Roseomonas mucosa bacteria and ground cardamom seeds against a placebo. Over about 7 months, participants will apply the mixture or placebo to their skin several times per week and complete online questionnaires.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
Roseomonas and Cardamom seeds
Group II: PlaceboPlacebo Group1 Intervention
Sucrose

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Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Findings from Research

In a trial involving 31 children with atopic dermatitis, oral sodium cromoglycate (SCG) significantly reduced eczema severity compared to a placebo, particularly when the placebo was given first.
The study suggests that SCG can effectively manage eczema flare-ups triggered by food allergies, as evidenced by both clinician assessments and parent-reported diary scores over a total treatment duration of 16 weeks.
Double-blind crossover trial with oral sodium cromoglycate in children with atopic dermatitis due to food allergy.Businco, L., Benincori, N., Nini, G., et al.[2013]
Kamillosan(R) cream, which contains chamomile extract, was found to be effective for treating medium-degree atopic eczema, showing mild superiority over 0.5% hydrocortisone cream in a randomized half-side comparison study.
The study demonstrated that Kamillosan(R) cream has a low allergen potential, making it a safe option for local therapy in patients with atopic eczema, with results observed after a 2-week treatment period.
Proof of efficacy of Kamillosan(R) cream in atopic eczema.Patzelt-Wenczler, R., Ponce-Pöschl, E.[2022]
The Kamedis Eczema Therapy Cream, which contains a botanical combination, significantly improved symptoms of mild to moderate Atopic Dermatitis compared to a vehicle cream without botanicals, as shown by better scores in the Investigator Global Assessment (IGA) and affected body surface area (BSA) across all treatment visits.
Both the Kamedis cream and a leading OTC comparator achieved the same percentage of subjects rated as 'clear' (34%), indicating that the botanical formulation is as effective as a well-known treatment while providing additional benefits over the vehicle cream.
Validation of Botanical Treatment Efficiency for Adults and Children Suffering from Mild to Moderate Atopic DermatitisDraelos, ZD., Traub, M., Gold, MH., et al.[2020]

References

Double-blind crossover trial with oral sodium cromoglycate in children with atopic dermatitis due to food allergy. [2013]
Proof of efficacy of Kamillosan(R) cream in atopic eczema. [2022]
Validation of Botanical Treatment Efficiency for Adults and Children Suffering from Mild to Moderate Atopic Dermatitis [2020]
Reliéva, a Mahonia aquifolium extract for the treatment of adult patients with atopic dermatitis. [2007]
A new flavonoid from Stellera chamaejasme L., stechamone, alleviated 2,4-dinitrochlorobenzene-induced atopic dermatitis-like skin lesions in a murine model. [2020]
Allergic contact dermatitis from cardamom. [2019]
Cardamonin Inhibits Oxazolone-Induced Atopic Dermatitis by the Induction of NRF2 and the Inhibition of Th2 Cytokine Production. [2020]
Protective Role of Phenolic Compounds from Whole Cardamom (Elettaria cardamomum (L.) Maton) against LPS-Induced Inflammation in Colon and Macrophage Cells. [2023]
Anti-hypercholesterolemic influence of the spice cardamom (Elettaria cardamomum) in experimental rats. [2017]
10.United Statespubmed.ncbi.nlm.nih.gov
First-in-human topical microbiome transplantation with Roseomonas mucosa for atopic dermatitis. [2019]
11.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Lactobacillus rhamnosus cell lysate in the management of resistant childhood atopic eczema. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Therapeutic responses to Roseomonas mucosa in atopic dermatitis may involve lipid-mediated TNF-related epithelial repair. [2021]
[Probiotics and prebiotics for the prevention and treatment of atopic eczema]. [2018]