Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2025-12-28 @ 9:35 PM
Study NCT ID:
NCT05202366
Status:
UNKNOWN
Last Update Posted:
2022-04-07
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label Study Evaluating the Effectiveness of CGB-400 Topical Gel for Fungal Infection
Sponsor:
CAGE Bio Inc.
Organization:
Study Overview
Official Title:
An Open-label Cosmetic Study to Evaluate the Effectiveness of CGB-400 Topical Gel for Improving Appearance of Toenails Affected by Fungal Infection
Status:
UNKNOWN
Status Verified Date:
2022-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: