NCT06923228

A Study to Assess Efficacy and Safety of CGB-500, 1% Tofacitinib Versus an Active Comparator for Atopic Dermatitis

A Single-Blind, Prospective Clinical Study to Assess the Efficacy, Safety and Tolerability of CGB-500 1% Tofacitinib Ointment vs. an Active Comparator for Atopic Dermatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: CAGE Bio Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if drug CGB-500 works to treat atopic dermatitis in subjects 12 years of age or older. It will also learn about the safety of CGB-500. The main questions it aims to answer are: Does CGB-500 decrease the severity of atopic dermatitis on the skin? What medical problems do participants have when taking drug CGB-500? Researchers will compare CGB-500 to a an approved product (1.5% ruxolitinib) to see if CGB-500 works to treat atopic dermatitis. Participants will: Apply CGB-500 and ruxolitinib to different locations on their body twice a day for four weeks. Visit the clinic six times for checkups and tests Keep a diary of their symptoms and when they apply the product

Conditions

• Atopic Dermatitis (AD)

Interventions

Type	Name	Description
DRUG	CGB-500 Ointment with 1% tofacitinib	experimental drug
DRUG	Ruxolitinib 1.5% Cream QD	topical cream

Timeline

• Start date: 2025-04-21
• Primary completion: 2025-07-30
• Completion: 2025-09-30
• First posted: 2025-04-11
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study