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

Study Overview
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Brief Summary
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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.

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

Conditions
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Fungal Infection, Onychomycosis, Tinea Unguium

Intervention / Treatment
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* Drug: CGB-400 Topical Gel


Participation Criteria
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Eligibility Criteria
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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. 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. Scheduled or planned surgical procedures during the course of the study. Unable or unwilling to comply with any of the study requirements. Medical or psychiatric conditions, or a personal situation, that may increase the risk associated with study participation or may interfere with interpretation of study results or subject compliance and, in the opinion of the PI, makes the subject inappropriate for study entry. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability. Exposure to any other investigational drug/device within 30 days prior to study entry.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Treatment group<br>Only one treatment group (CGB-400 Topical Gel) will be used for analysis | Drug: CGB-400 Topical Gel<br>* 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.<br>* Other names: CGB-400C Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment (IGA) of affected toenails | Clear 0% nail involvement Almost clear 0%-≤10% nail involvement Mild 10%-<25% nail involvement Moderate 25%-≤50% nail involvement Severe >50%-≤75% nail involvement | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent clear area on affected toenail/region (s) | *Clear nail is defined as area from proximal nail fold till most proximal area of abnormality with evidence of persistent clear growth. Clearance must be progressively observed over two time points. | 24 weeks | 
| Visual inspection (pictures to be collected) | Visual inspection for application site reactions: performed at each visit along with images taken by subjects and at the time of clinic visit | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fungal growth, Fungal infection, Onychomycosis, Nail trauma