The Onycho Trial

Phase 3

Completed

• Conditions: <p>Onychomycosis</p>; Fungal nail infection; nail fungus; tinea unguium; 10017528

• Registration Number: NL-OMON26092
• Lead Sponsor: eiden University Medical Center (LUMC)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 111

Inclusion Criteria

1. Leeftijd 18 - 70 jaar

2. Onychomycose van 1 tot maximaal 3 nagels per voet

Exclusion Criteria

1. Bekende allergie of overgevoeligheid voor een van de onderzoeksmedicijnen

2. Zwangerschap of borstvoeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Complete cure, consisting of both clinical and mycological cure of the index toenail at 6 months&nbsp;</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical improvement (defined as either =10% involvement of the index toenail or as =40% reduction)<br /><br>Symptom burden as expressed by the ONYCHO questionnaire score<br /><br>Quality of life based on the Short Form-12 survey<br /><br>Adverse effects<br /><br>Therapy compliance<br /><br>Patient-perceived improvement<br /><br>Treatment acceptability</p><br>