FunghiClear clinical study results: What 192 patients showed after 12 weeks
We talk a lot about what FunghiClear is designed to do. Now we want to share what it actually did in a real clinical setting, with real patients, documented over 12 weeks.
In late 2025, a post-marketing clinical evaluation of FunghiClear was published, conducted across six countries and supervised by podiatrists, dermatologists, and medical pedicurists. Here is what the study found, and why it matters for anyone managing toenail onychomycosis.
The study at a glance
The study enrolled adults between the ages of 18 and 65 with confirmed dermatophyte onychomycosis, the most common form of toenail fungus. Participation took place across the Netherlands, Belgium, the United Kingdom, Taiwan, and Scandinavia (Norway and Sweden).
Onychomycosis was confirmed through laboratory testing: PCR analysis of toenail clippings in the Netherlands and Belgium, rapid immunochromatography tests in the UK and Scandinavia, and clinical diagnosis by dermatologists in Taiwan.
192 participants were followed for 12 weeks while using the FunghiClear. The average age was 49 years. Many had been dealing with the condition for a long time, with 47% reporting living with suspected onychomycosis for five years or more. About half had tried some form of treatment before, ranging from over-the-counter products to prescription medication.
Each participant used FunghiClear as directed on the label: twice daily on the affected toenail and surrounding skin. They visited their footcare professional at baseline, at week 6, and at week 12.
How progress was measured
Footcare professionals assessed participants using two objective tools:
The Onychomycosis Severity Index (OSI) a standardised, validated scoring method that accounts for the area of nail affected, how close the infection is to the nail matrix, and the presence of specific clinical signs. Scores range from 0 (healthy) to 35 (severe).
A five-stage Toenail Rating scale assessing inflammation, nail structure, nail colour, and visible healthy regrowth. A higher stage indicates a healthier nail.
Both assessments were taken at baseline and at week 12. Participants and professionals also reported their own perception of change.
The results
After 12 weeks of using FunghiClear:
- 67% of participants (129 out of 192) showed a measurable improvement in their OSI score
- Among those who improved, the mean OSI score improved by 44% (8.82 points reduction in severity)
- Toenail Rating improved by an average of 0.96 stages (44% improvement) in the same group
- 74% of participants felt their toenail was better or much better than at the start
- 73% of footcare professionals independently reported visible improvement in the participant's toenail
- 18% showed no change, meaning the condition had not progressed
On safety, the results were equally clear. 191 out of 192 participants (99.5%) reported no pain or discomfort at the site of application. One person noted mild tingling on application. No serious adverse events were reported across the entire study.
Participants also rated the experience of using FunghiClear highly:
- Convenience of the upside-down spray bottle: 4.4 out of 5
- Ability to comply with twice-daily use: 4.5 out of 5
- Overall user experience: 4.5 out of 5
Why a 12-week study makes sense for this condition
Toenail onychomycosis is slow. A toenail takes 12 to 18 months to fully regrow, and clinical guidelines typically recommend topical treatment for at least 48 weeks. This study did not aim to show complete resolution, that would require a much longer timeframe. The goal was to assess whether meaningful improvement was detectable within a 12-week window.
That 67% of participants showed objective improvement within that window, and that 18% showed stabilisation rather than progression, is an excellent result. The study authors also note that preventing the condition from advancing may also be considered a positive outcome, given how difficult toenail onychomycosis is to reverse once severe.
Who conducted the study
The study was initiated by Norman Health Products & Services B.V., the manufacturer of FunghiClear. Participants were recruited and supervised by footcare professionals across six countries: medical pedicurists in the Netherlands and Belgium, podiatrists and chiropodists in the UK, dermatologists in Taiwan, and podiatrists in Norway and Sweden. The evaluation was published in November 2025 with DOI: 10.20944/preprints202511.0567.v1.
The authors acknowledge the study's limitations openly: there was no control group and no blinding. This is an ongoing study, with plans to expand participation and extend findings.
What this means in practice
For anyone using FunghiClear, or considering it, this study provides an evidence base grounded in real-world use. While not a controlled laboratory experiment, 192 people across multiple countries using the product as part of their regular care routine with professional supervision were observed for actual outcomes.
The results support what FunghiClear is designed to do: provide a safe, convenient, and effective option for managing toenail onychomycosis over the long term, starting with measurable change in the first three months.
Read the full study here→ https://funghiclear.eu/pages/clinical-evaluation-study