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

NCT05202366 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 15

Last updated 2026-04-02

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • John Peter Smith Hospital

    collaborator UNKNOWN

  • CAGE Bio Inc.

    lead INDUSTRY

Principal Investigators

  • Travis Motley, DPM · JPS

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2024-08-08
Completion
2024-08-08

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05202366 on ClinicalTrials.gov