NCT04886739

CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea

Safety and Effectiveness of CGB-400 Topical Gel for the Treatment of Inflammatory Lesions of Rosacea: A Randomized, Double-Blind, Vehicle-Controlled Proof of Concept Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: CAGE Bio Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, vehicle-controlled, parallel design study evaluating the efficacy and safety of CGB-400 Topical Gel for the treatment of inflammatory lesions of rosacea. The study consists of a 12-week double-blind treatment period with clinic visits at Baseline (Day 0), and Weeks 2, 4, 8, and 12. Approximately 80 subjects will be enrolled and randomized at a 1:1 ratio to treatment with either CGB-400 Topical Gel (40%) BID or Vehicle Gel BID.

Conditions

• Rosacea

Interventions

Type	Name	Description
DRUG	CGB-400	Topical gel
DRUG	Vehicle Gel	Topical gel

Timeline

• Start date: 2021-05-07
• Primary completion: 2021-12-22
• Completion: 2021-12-22
• First posted: 2021-05-14
• Last updated: 2026-04-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study