The FunghiClear™ Clinical Evaluation Study 2024
Study Summary: Pivotal Outcomes
Comprehensive Study Design
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Duration:
Each participant used FunghiClear™ Antifungal Spray twice daily for a consecutive 12-week period
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Inclusion Criteria:
Diagnosed with dermatophyte onychomycosis through:
- Positive PCR test (Dutch cohort)
- Rapid self-test (UK cohort)
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Protocol:
Each participant followed a treatment regimen where:
- Spray was applied to toes twice daily.
- Shoes were sprayed weekly to prevent re-infection.
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Participants:
The study included a diverse group of participants:
- Total: 145 adults
- Average Age: 51 years
- Duration of Infection: Average of 5.89 years
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Exclusion Criteria:
Participants were excluded if they had:
- Recent antifungal treatment
- Poor wound healing due to diabetes
- Severe immunocompromised conditions
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Conducted By:
The study was carried out by:
- Licensed podiatrists in the Netherlands, UK, and Belgium
- Medical pedicurists in the Netherlands, UK, and Belgium
Onychomycosis Severity Index (OSI)
Used to score the severity of onychomycosis at baseline and after 12 weeks. This standard methodology provided a quantitative measure of the infection's severity.
Photographic Ratings
Nails were photographed and rated at baseline, week 6, and week 12. Practitioners used phase cards to rate the condition of the nails on a five-point severity scale (1=the worst and 5=the best), representing five clinical stages of onychomycosis. The severity assessment was based on four criteria:
- Inflammation
- Nail structure
- Nail color
- Presence of healthy nail regrowth
Participant Feedback
Participants reported their levels of pain, discomfort, and convenience using FunghiClear™ on a scale from 1 (not convenient) to 5 (very convenient). This feedback provided comprehensive data on the product's user-friendliness and safety.
Reduction in Severity
- Statistical Outcome: 26.8% improvement in mean Onychomycosis Severity Index (OSI) scores from 18.38 at baseline to 13.46 by week 12.
- Clinical Significance: Indicates a substantial reduction in the severity of toenail fungus among participants.
- Detailed Observation: Significant clinical improvement with a 31.6% reduction in infected nail severity.
Nail Appearance Improvement
- Statistical Outcome: 22.4% enhancement in the ratings of affected toenails, from a baseline of 2.77 to 3.39 by week 12.
- Visual Impact: Reflects noticeable improvements in the appearance and health of nails.
- User Feedback: High comfort score of 4.2 out of 5, indicating user satisfaction with the visible improvements.
Safety Of Use
- User Feedback: 99% of participants reported no pain or discomfort, with no significant adverse events noted.
- Safety Profile: Reinforces FunghiClear™ as a gentle and safe option for toenail fungus treatment.
- Non-Systemic Action: Minimises risks associated with systemic reactions or drug interactions, ensuring suitability for sensitive populations, including children and the immunocompromised.
User-Convenience
- User Rating: An average convenience score of 4.41 out of 5.
- Practicality: Highlights the ease and practicality of using FunghiClear™ in daily routines.
- Comfort and Satisfaction: 99% of participants enjoyed a pain-free treatment experience, emphasising the product’s user-friendly design.
Mechanism of Action
- Active Ingredients: Manuka Oil for fungal inhibition, Basil Oil for enhanced penetration, and Mint and Lavender Oils for soothing effects.
- Functional Benefits: Each ingredient plays a critical role in the overall efficacy and user experience of the treatment.
- Efficacy Observations: The unique combination of ingredients not only targets fungal infections but also supports overall nail health and regrowth.
Concluding Remarks & Final Thoughts
