Cardamom and Topical Roseomonas in Atopic Dermatitis

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT06096857
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Roseomonas mucosa (RSM2015) and Cardamom seeds — DRUG
    Freeze dried packet to be reconstituted in water
  • Placebo (sucrose) — DRUG
    Freeze dried packet to be reconstituted in water

Study Details

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.

Key Dates

Start date
Oct 9, 2024
Status verified
Jun 2026
Primary completion
Jan 1, 2027
Completion
Jan 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active
    Roseomonas and Cardamom seeds
  • Placebo Comparator: Placebo
    Sucrose

Primary Outcome Measure

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. [ Time Frame: From Baseline (week 0 to week 28) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
NIH Clinical Center Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

Find similar trials in Bethesda, MD

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
National Institutes of Health Clinical Center· Bethesda, MD

Related Studies