NCT03382717

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: Oystershell NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Onychomycosis of Toenail

Interventions

Type	Name	Description
DEVICE	Excilor Forte	1 application per day during 6 months
DRUG	Loceryl 5%	1 application per week during 6 months

Timeline

• Start date: 2016-10-26
• Primary completion: 2017-08-26
• Completion: 2017-08-26
• First posted: 2017-12-26
• Last updated: 2024-03-15

Locations

2 sites across 1 country: Tunisia