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

NCT05202366 | Completed

• 1 other identifier: CGB-405
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Fungal Infection; Onychomycosis; Tinea Unguium

Keywords

Fungal growth; Fungal infection; Onychomycosis; Nail trauma

Outcome Measures

Primary Outcomes (1)

• Investigator Global Assessment (IGA) of affected toenails

  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

  24 weeks

Secondary Outcomes (2)

• Percent clear area on affected toenail/region (s)

  24 weeks

• Visual inspection (pictures to be collected)

  24 weeks

Other Outcomes (1)

• Subject Global Assessment

  24 weeks

Study Arms (1)

Treatment group

Only one treatment group (CGB-400 Topical Gel) will be used for analysis

Drug: CGB-400 Topical Gel

Interventions

CGB-400 Topical Gel DRUG

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.

Also known as: CGB-400C Gel

Treatment group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female ≥18 (and ≤99) at the time of Informed Consent will be involved in the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CAGE Bio Inc.: lead
• John Peter Smith Hospital: collaborator

Study Sites (1)

John Peter Smith Hospital

Fort Worth, Texas, 76104, United States

Location

MeSH Terms

Conditions

Mycoses; Onychomycosis

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections; Tinea; Dermatomycoses; Skin Diseases, Infectious; Nail Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Travis Motley, DPM

  JPS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2022
• First Posted: January 21, 2022
• Study Start: February 8, 2022
• Primary Completion: August 8, 2024
• Study Completion: August 8, 2024
• Last Updated: April 2, 2026

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: 24 weeks
• Access Criteria: Research data, in hard copy or electronic form (CDs, DVDs, digital or magnetic tape, hard-drives, flash-memory drives, etc.) will be stored and managed in a secure manner following federal guidelines and according to state and institutional policies and practices. Further, research documents including electronic documents containing subject data, identifiers and linked data will be securely stored in locked containers (file cabinets, lockers, drawers, etc.) in accordance with standard document management practices. At all times, only listed key personnel specifically designated and authorized by the Principal Investigator shall have access to any research related documents. All such personnel will be properly trained and supervised regarding the management and handling of confidential materials. The Principal Investigator assumes full responsibility for such training, supervision, and conduct.

Locations

US (1)