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NCT05202366 · ClinicalTrials.gov registry record

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

A clinical trial, sponsored by CAGE Bio.

Completed
Registry status
15
Enrollment target

NCT05202366: Completed study, sponsored by CAGE Bio.

NCT05202366 is a clinical trial that has completed, run by CAGE Bio. The registered enrollment target is 15 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05202366 has completed, sponsored by CAGE Bio.

COMPLETED
Registry status
15 participants
Enrollment target

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.

Primary Outcome

Clear 0% nail involvement 1. Almost clear 0%-≤10% nail involvement 2. Mild 10%-\<25% nail involvement 3. Moderate 25%-≤50% nail involvement 4. Severe \>50%-≤75% nail involvement

Interventions

  • DRUG CGB-400 Topical Gel

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2022-02-08
Est. Completion 2024-08-08
CAGE Bio

8 total trials

What the finished NCT05202366 record still lists

NCT05202366 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 15 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which CGB-400 Topical Gel is the first listed.

NCT05202366 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05202366 about?

NCT05202366 is a clinical study titled "An Open-label Study Evaluating the Effectiveness of CGB-400 Topical Gel for Fungal Infection". 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 ...

What is the current status of trial NCT05202366?

This trial is currently completed. The enrollment target is 15 participants. The study started on 2022-02-08. Estimated completion is 2024-08-08.

What interventions are being tested in trial NCT05202366?

The interventions under investigation include: CGB-400 Topical Gel (DRUG).

Who is sponsoring clinical trial NCT05202366?

This trial is sponsored by CAGE Bio, which has 8 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT05202366, the US trial registry maintained by the National Library of Medicine. NCT05202366 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.