New foot fungus film shows promise in early trial
NCT ID NCT07668999
First seen Jun 27, 2026 · Last updated Aug 05, 2026 · Updated 2 times
Summary
This early-stage trial tests a new topical film called ZYG24004 for athlete's foot (tinea pedis). About 64 adults with the infection will apply the film to their feet once or twice. The main goals are to check safety, how the body processes the drug, and whether it can clear the fungus. Results will help decide if larger studies are warranted.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ZYG24004 (a topical film-forming formulation applied to the feet)
- What this could lead to
- If successful, this could point toward a new topical treatment for athlete's foot that is easy to apply and may require fewer doses.
- What could go wrong
- This is a very early Phase 1b study with only 64 participants, focused on safety and dosing. It is too small to prove effectiveness, and the treatment may not work better than a placebo.
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.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 64 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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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.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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 participants aged 18 to 65 years; body weight \>=50 kg for males and \>=45 kg for females; body mass index (BMI) 18.5 to 28.0 kg/m2, inclusive. 2. Clinically diagnosed tinea pedis, with lesions located in the interdigital area and possibly involving the sole and lateral foot. 3. Positive mycological test of the target foot at screening, based on fungal microscopy. 4. Target-foot clinical signs and symptoms score \>=3. 5. In generally good health, with no serious or uncontrolled systemic disease, and considered by the investigator to be suitable for participation. 6. The participant or the participant's partner is not pregnant or breastfeeding, and the participant agrees to use reliable contraception throughout the study and for 3 months after the last administration. 7. Willing and able to comply with scheduled visits and protocol requirements, and able to understand and sign the informed consent form. Exclusion Criteria: 1. Hyperkeratotic tinea pedis, or tinea pedis accompanied by erosion, exudation, or ulceration. 2. Concomitant onychomycosis of the feet or other active fungal disease. 3. Bacterial or viral skin infection of the feet, or severe skin disease judged by the investigator to affect study assessments, such as severe eczema, psoriasis, atopic dermatitis, or chronic dermatitis. 4. History of dermatophyte infection that was ineffective to prior antifungal therapy. 5. Use of systemic antifungal drugs within 3 months before enrollment. 6. Use of topical antifungal drugs, such as terbinafine cream, butenafine cream, ciclopirox, clotrimazole, or miconazole, or topical corticosteroid-containing drugs within 4 weeks before enrollment. 7. Use of topical antibacterial drugs, disinfectants, keratolytic agents such as salicylic acid, or other topical treatment on the feet within 2 weeks before enrollment. 8. Use of oral antihistamines within 1 week before enrollment. 9. Use of systemic corticosteroids or immunosuppressive drugs within 4 weeks before enrollment. 10. Serious or uncontrolled cardiovascular, hepatic, renal, neurological, psychiatric, or immune system disease. 11. History of diabetes mellitus or fasting blood glucose above the upper limit of normal. 12. Clinically significant abnormalities in physical examination, hematology, blood chemistry, urinalysis, 12-lead electrocardiogram, infectious disease screening, coagulation function, or other assessments. 13. Currently participating in another clinical trial, or participation in another clinical trial within 30 days before the baseline visit or within 5 half-lives of the investigational product, whichever is longer. 14. Known severe allergy or intolerance to ZYG24004 or any excipients of the formulation, including film-forming polymers or ethanol. 15. Addiction to smoking, defined as \>10 cigarettes per day. 16. Diagnosis of alcohol dependence or drug dependence within the past 12 months, or any situation judged by the investigator to affect compliance. 17. Any other condition that, in the investigator's opinion, may interfere with study results or make participation unsafe.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Peking University First Hospital
RECRUITINGBeijing, Beijing Municipality, 100034, China
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