An Open-label Study Evaluating the Effectiveness of CGB-400 Topical Gel for Fungal Infection (NCT05202366) | Clinical Trial Compass
CompletedNot Applicable
An Open-label Study Evaluating the Effectiveness of CGB-400 Topical Gel for Fungal Infection
United States15 participantsStarted 2022-02-08
Plain-language 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.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female ≥18 (and ≤99) at the time of Informed Consent.
. Nail fungal infection of at least one great toe \[per visual assessment by the clinical investigator\]
. Subjects who have target toenail showing 20-65% involvement as judged by the clinical investigator.
. Subject must be physically able to reach toes to clean them and apply product.
. Subject is willing to discontinue use of other nail fungus treatment products and nail cosmetic products for duration of this study.
. Subject is willing and available to return for study follow up.
. Signed written informed consent form (ICF) prior to any trial related activity (subjects must have the mental, literate, and legal ability to give a written informed consent, which must comply with the ICH GCP guidelines and local requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Investigator Global Assessment (IGA) of affected toenails
. Agree to take and share pictures of the treated toenails on a periodic basis during the study and follow-up period.
Exclusion criteria
. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.
. Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Product (i.e., essential oils, fragrance, choline, phosphatidylcholine, propylene glycol, limonene, cellulose).
. Nails with clinical evidence of no or low distal growth.
. History or presence of another skin/nail condition/disease that is located in the treatment area(s) and might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, psoriasis, significant actinic damage, vitiligo, open wounds, infection, etc.).
. Basal cell carcinoma within 6 months of Visit 1.
. Uncontrolled systemic disease.
. Foreseen unprotected and intense/excessive UV exposure during the course of the study.
. Use of prohibited concomitant medications/procedures, as specified below in Table 2, during the study or within the defined washout periods.