Onychomycosis of Toenail Clinical Trial
Official title:
Clinical Trial of Safety and Efficacy of Topical ABL01 Treatment of Onychomycosis
This clinical trial seeks to investigate if an experimental medical device, ABL01, can be used to treat onychomycosis. In a 1-year trial the effectiveness of ABL01 will be tested against placebo in 70 study subjects with onychomycosis of the big toe nail. The endpoint of the trial is clinical improvement and cure at the 6 and 12 month time-point.
The purpose of this clinical trial is to determine the safety and effectiveness of the
medical device ABL01. The intended use of ABL01 is to reduce and treat onychomycosis, fungal
nail infection. ABL01 is a solution intended to be topically administered weekly to infected
nails. The trial is designed as a double blinded randomized placebo controlled clinical
trial. The trial involves 70 study subjects, half of which will receive ABL01 and the other
half placebo. The inclusion criteria for study subjects are adult men and women that present
with distal lateral subungual onychomycosis (DSU) on the big toe nails. Furthermore, the
extent of DSU should not involve more than half of the area of the nail.
The study subjects will themselves apply the study solution weekly to the treated nail. The
trial will run for 6 months with a possible extension to maximum 12 months. There will be a
total of 4 study visits at baseline, 3, 6 and 12 months to follow up the progress of the
trial. The primary objective of the trial is to determine if ABL01 treatment are able to
reduce and treat onychomycosis. Secondary objectives are to collect safety data, determine if
the ABL01 are perceived as easy to use and assess long term effects of the treatment. The
endpoint of the trial is reduction in clinical signs or complete cure of onychomycosis at the
6- or 12-month time-point.
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|---|---|---|---|
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