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RECRUITING
NCT06096857
PHASE2

Cardamom and Topical Roseomonas in Atopic Dermatitis

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

2 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-10-09

Completion Date

2027-01-01

Last Updated

2026-01-23

Healthy Volunteers

No

Interventions

DRUG

Roseomonas mucosa (RSM2015) and Cardamom seeds

Freeze dried packet to be reconstituted in water

DRUG

Placebo (sucrose)

Freeze dried packet to be reconstituted in water

Locations (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States