RecruitingPhase 2NCT06096857

Cardamom and Topical Roseomonas in Atopic Dermatitis

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


Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

Enrollment

120 participants

Start Date

Oct 9, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 2 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo (sucrose) and a drug called Roseomonas mucosa (RSM2015) and Cardamom seeds for people with atopic dermatitis and eczema. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRoseomonas mucosa (RSM2015) and Cardamom seeds

Freeze dried packet to be reconstituted in water

DRUGPlacebo (sucrose)

Freeze dried packet to be reconstituted in water


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06096857


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