Status:
UNKNOWN
An Open-label Study Evaluating the Effectiveness of CGB-400 Topical Gel for Fungal Infection
Lead Sponsor:
CAGE Bio Inc.
Collaborating Sponsors:
John Peter Smith Hospital
Conditions:
Fungal Infection
Onychomycosis
Eligibility:
All Genders
18-99 years
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 affec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 8 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 15 2022
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05202366
Start Date
February 8 2022
End Date
September 15 2022
Last Update
April 7 2022
Active Locations (1)
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1
John Peter Smith Hospital
Fort Worth, Texas, United States, 76104