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

Sponsor
CAGE Bio Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05202366
Collaborator
John Peter Smith Hospital (Other)
15
1
7.2
2.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: CGB-400 Topical Gel

Study Design

Study Type:
Observational
Anticipated Enrollment :
15 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
An Open-label Cosmetic Study to Evaluate the Effectiveness of CGB-400 Topical Gel for Improving Appearance of Toenails Affected by Fungal Infection
Actual Study Start Date :
Feb 8, 2022
Anticipated Primary Completion Date :
Aug 8, 2022
Anticipated Study Completion Date :
Sep 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Treatment group

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

Drug: CGB-400 Topical Gel
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.
Other Names:
  • CGB-400C Gel
  • Outcome Measures

    Primary Outcome Measures

    1. Investigator Global Assessment (IGA) of affected toenails [24 weeks]

      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

    Secondary Outcome Measures

    1. Percent clear area on affected toenail/region (s) [24 weeks]

      *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.

    2. Visual inspection (pictures to be collected) [24 weeks]

      Visual inspection for application site reactions: performed at each visit along with images taken by subjects and at the time of clinic visit

    Other Outcome Measures

    1. Subject Global Assessment [24 weeks]

      The Subject Global Assessment will be collected in the form "subject questionnaire" SUBJECT QUESTIONNAIRE: The Investigator (or designate) will ask the following questions at the Baseline visit and subject's answers will be recorded: How frequently do you typically experience fungal growth each month? How do you rate your fungal growth today relative to other times? Are you aware of specific triggers that aggravate fungal growth? How do you deal with or treat fungal growth? What other products have you tried in the past for managing/treating fungal growth? Are there any other aspects of fungal growth or experience that we should know about?

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 99 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    1. Male or female ≥18 (and ≤99) at the time of Informed Consent.

    2. Nail fungal infection of at least one great toe [per visual assessment by the clinical investigator]

    3. Subjects who have target toenail showing 20-65% involvement as judged by the clinical investigator.

    4. Subject must be physically able to reach toes to clean them and apply product.

    5. Subject is willing to discontinue use of other nail fungus treatment products and nail cosmetic products for duration of this study.

    6. Subject is willing and available to return for study follow up.

    7. 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.

    8. Agree to take and share pictures of the treated toenails on a periodic basis during the study and follow-up period.

    Exclusion Criteria:
    1. Female subjects that are pregnant, breast-feeding, or of childbearing potential and not practicing reliable birth control.

    2. Known hypersensitivity or previous allergic reaction to any constituent of the Investigational Product (i.e., essential oils, fragrance, choline, phosphatidylcholine, propylene glycol, limonene, cellulose).

    3. Nails with clinical evidence of no or low distal growth.

    4. 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.).

    5. Basal cell carcinoma within 6 months of Visit 1.

    6. Uncontrolled systemic disease.

    7. Foreseen unprotected and intense/excessive UV exposure during the course of the study.

    8. Use of prohibited concomitant medications/procedures, as specified below in Table 2, during the study or within the defined washout periods.

    9. Scheduled or planned surgical procedures during the course of the study.

    10. Unable or unwilling to comply with any of the study requirements.

    11. 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.

    12. Clinically significant alcohol or drug abuse, or history of poor cooperation or unreliability.

    13. Exposure to any other investigational drug/device within 30 days prior to study entry.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 John Peter Smith Hospital Fort Worth Texas United States 76104

    Sponsors and Collaborators

    • CAGE Bio Inc.
    • John Peter Smith Hospital

    Investigators

    • Principal Investigator: Travis Motley, DPM, JPS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CAGE Bio Inc.
    ClinicalTrials.gov Identifier:
    NCT05202366
    Other Study ID Numbers:
    • CGB-405
    First Posted:
    Jan 21, 2022
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by CAGE Bio Inc.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 7, 2022