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New gel shows promise for ugly toenail fungus

NCT ID NCT05202366

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a special gel, CGB-400, on 15 adults with toenail fungus. The goal was to see if the gel could clear the fungus and make the nails look better. Participants applied the gel for 12 weeks, with follow-up visits to check progress.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

15 people

The number who actually took part.

Started

Feb 2022

Finished

Aug 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • John Peter Smith Hospital

    Fort Worth, Texas, 76104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.