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Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis

Onychomycosis of Toenail Clinical Trial

Official title:
Clinical Evaluation of Efficacy and Safety of a Medical Device for the Treatment of Toenail Onychomycosis.

Clinical Trial Summary

This study evaluates the effect of the medical device "Excilor® Forte" in the treatment of toenail onychomycosis. Half of the participants will receive the tested product and the other half will receive a comparator (Amorolfin 5%). Patients will be followed during 6 months.

Clinical Trial Description

Subjects with a great toenail, affected by onychomycosis, were treated with the test medical device or reference product, respectively. After 180 days, blind assessment of the % of healthy surface (primary end point) of the great toenail was performed to compare the effect of both treatments, and to evaluate improvement versus baseline (day 0), respectively. Additionally, blind assessment of the percentage of healthy surface of the great toenail was performed at all other visits (D30, D60, D120) to evaluate changes from baseline between both treatment groups. For this purpose, digital macrophotographs were analysed by a blinded investigator using Adobe Photoshop software. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03382717
Study type Interventional
Source Oystershell NV
Contact
Status Completed
Phase N/A
Start date October 26, 2016
Completion date August 26, 2017
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See also
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