drugset / Trial / NCT06810050

Phase 2b Safety and Efficacy Study of CGB-500 Topical Ointment With 0.5% and 1% Tofacitnib for Treatment of Atopic Dermatitis

NCT06810050

Phase 2 Completed 180 enrolled CAGE Bio Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The goal of this clinical trial is to learn if CGB-500 works to treat atopic dermatitis in participants ages 12 and older. The goal is also to learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 improve atopic dermatitis by decreasing the area affected and the severity of the lesions? What medical problems do participants have when taking CGB500? Researchers will compare CGB-500 to a placebo (a look-alike substance that contains no drug) to see if CGB-500 works to treat atopic dermatitis. Participants will: Take CGB-500 or a placebo every day for 8 weeks. Visit the clinic once every 2 weeks for the first month and at the end of 8 weeks. Keep a diary of when they use the product and complete a form about their symptoms including itching.

Timeline

Start
2024-12-18
Primary completion
2025-08-30
Completion
2025-10-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Tofacitinib Small molecule 0.5 %
Subject Tofacitinib Small molecule 1 %

Indications