Phase 2b Trial of Topical Roseomonas mucosa and Cardamom Seeds for Treating Atopic Dermatitis in Patients Age 2 and Older

What this Trial Is About

Atopic dermatitis AD, also known as eczema, is a chronic skin condition that causes dryness and itching and can lead to complications like asthma and food allergies. Researchers are studying a topical treatment combining harmless bacteria called Roseomonas mucosa with ground cardamom seeds to see if it can improve symptoms in people aged 2 years and older with AD. This phase 2b trial compares this treatment to a placebo to evaluate its impact on AD symptoms and the skin microbiome. Participants will apply a study product made from freeze-dried Roseomonas mucosa and cardamom seeds or a placebo powder mixed with water in a spray vial. They will spray this solution on their skin 2 to 3 times per week for 14 weeks. After the treatment period, there is a 14-week follow-up without treatment to assess how long any effects last. The trial is double-blind and randomized, with half the participants receiving the active treatment and half receiving placebo. Participants will join remotely with five visits over about seven months. They will provide skin swabs collected at three visits by mailing swab samples to researchers. Optional photographs of their skin condition may be taken. Participants will also complete four online questionnaires. Researchers will measure eczema severity, itch, rash, quality of life, and safety outcomes throughout treatment and follow-up. The main measure is improvement in eczema severity 14 weeks after stopping treatment.

Cardamom and Topical Roseomonas in Atopic Dermatitis