NCT05202366

An Open-label Study Evaluating the Effectiveness of CGB-400 Topical Gel for Fungal Infection

An Open-label Cosmetic Study to Evaluate the Effectiveness of CGB-400 Topical Gel for Improving Appearance of Toenails Affected by Fungal Infection

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 15 (actual)
• Sponsor: CAGE Bio Inc. · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The goal of the current study is to evaluate the ability of CGB-400, a proprietary eutectic mixture of GRAS compounds, to clear the toenail fungal growth and improve the appearance of the fungus affected area(s). This is an open-label, single group POC study evaluating the effectiveness of CGB-400 Topical Gel for toenail fungal growth clearing. The study consists of a 12-week period with 5 clinic visits at the following timepoints: Baseline (Day 0), and Weeks 2, 6, and 12 and post-application follow-up at Week 24. The applications could be extended for an additional 12 weeks based on PI's observations. Approximately 15 subjects will be enrolled and subjected to application of CGB-400 Topical Gel. Subjects must be at least 18 years of age and will be selected by the concerned PI.

Conditions

• Fungal Infection
• Onychomycosis
• Tinea Unguium

Interventions

Type	Name	Description
DRUG	CGB-400 Topical Gel	CGB-400 Gel contains two main ingredients: geranic acid and choline. Geranic acid, a naturally occurring essential oil/terpenoid, is a key ingredient in lemon grass and is also found in other natural materials such as cardamom. The other main ingredient in CAGE is choline, which is an essential dietary component and found in foods as free choline and as several esterified forms such as phosphocholine and phosphatidylcholine.

Timeline

• Start date: 2022-02-08
• Primary completion: 2024-08-08
• Completion: 2024-08-08
• First posted: 2022-01-21
• Last updated: 2026-04-02

Locations

1 site across 1 country: United States