Fungal InfectionNCT05202366
An Open-label Study Evaluating the Effectiveness of CGB-400 Topical Gel for Fungal Infection
An observational study of Fungal Infection and Onychomycosis, run by CAGE Bio Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Fungal Infection, Onychomycosis, Tinea Unguium
- What is being tested?
- CGB-400 Topical Gel
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Feb 2022to 8 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male or female ≥18 (and ≤99) at the time of Informed Consent will be involved in the study.
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- CGB-400 Topical Gel
- Keywords
- Fungal growth, Fungal infection, Onychomycosis, Nail trauma
- Medical subject headings
- Mycoses, Onychomycosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGB-400 Topical GelDrug
Also called CGB-400C 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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Only one treatment group (CGB-400 Topical Gel) will be used for analysis Receives: Drug: CGB-400 Topical Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 weeks
Secondary outcomes (2)
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.
Measured: 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
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start8 Feb 2022
- Primary completion8 Aug 2024
- Study completion8 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fungal InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- CAGE Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- John Peter Smith Hospital
- Responsible party
- Sponsor
- Investigators
- Travis Motley, DPM, Principal investigator, JPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05202366
- Sponsor's protocol ID
- CGB-405
- Status last verified
- Apr 2022
- First submitted
- 10 Jan 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05202366
- Acronym / sponsor ID
- CGB-405
- Conditions
- Fungal Infection, Onychomycosis, Tinea Unguium
- Keywords
- Fungal growth, Fungal infection, Onychomycosis, Nail trauma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- CAGE Bio Inc.Industry (pharma, biotech, devices)
- Collaborators
- John Peter Smith Hospital
- Study start
- 8 Feb 2022 (actual)
- Primary completion
- 8 Aug 2024 (actual)
- Study completion
- 8 Aug 2024 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Drug: CGB-400 Topical GelOnly one treatment group (CGB-400 Topical Gel) will be used for analysis |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male or female ≥18 (and ≤99) at the time of Informed Consent will be involved in the study.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CGB-400 Topical GelAlso: CGB-400C GelCGB-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. | Drug | Treatment group |
Primary outcome
Investigator Global Assessment (IGA) of affected toenails
Time frame: 24 weeks
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
2 secondary outcomes
Percent clear area on affected toenail/region (s)
Time frame: 24 weeks
Visual inspection (pictures to be collected)
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2026.
- Individual participant dataSharing planned: Yes
Related trials for Fungal Infection
RecruitingObservational study
Natural History of Individuals With Immune System Problems That Lead to Fungal Infections
Chronic Mucocutaneous Candidiasis, Invasive Aspergillosis
RecruitingObservational study
Studies of Disorders With Increased Susceptibility to Fungal Infections
Fungal Infections, Primary Immune Deficiencies
Enrolling by invitationPhase 3
Rezafungin Prophylaxis in Liver Transplant
Liver Transplant Infection, Fungal Infection
Not yet recruitingPhase 2
A Phase II Randomized Study to Evaluate Measures for Endpoint Derivation in Patients With Progressive or Refractory Disseminated Coccidioidomycosis Treated With Olorofim Plus Baseline Standard of Care or Placebo Plus Baseline Standard of Care
Coccidioidomycosis, Disseminated Fungal Infection
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Travis Motley, DPM principal investigator
JPS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fungal Infection and Onychomycosis, run by CAGE Bio Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Assessment (IGA) of affected toenails (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.