Clinical improvement |
Photographs |
Judged by investigator |
(Scoring Clinical Index for Onychomycosis (SCIO) score). Decrease in thickness of subungual hyperkeratosis from the original untreated nail |
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Clinical cure |
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Judged by investigator (> 90% clinical improvement) |
Scoring Clinical Index for onychomycosis (SCIO) score (> 90% clinical improvement) |
Visual inspection, investigator judgement (> 90% clinical improvement) |
Nail dystrophy, thickness and a photographic record |
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Mycological cure |
Fungal culture |
Microscopy and fungal culture |
Potassium hydroxide and fungal cultures |
Microscopy and fungal culture |
Potassium hydroxide and fungal cultures |
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Complete cure |
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Mycological cure + clinical cure |
Mycological cure + clinical cure |
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Adverse events |
Participant-reported |
Investigator assessment of erythema, irritation, pruritus, desquamation, and patient self-reporting of a burning sensation of the skin surrounding the treated nail (4-point scales) |
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Participant- reported and clinician driven visual inspection |
Participant-reported and clinician driven visual inspection |