Effectiveness of local treatment for onychomycosis

Phase 4

Completed

• Conditions: fungal infection of the nail; 10040798

• Registration Number: NL-OMON52904
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2023-03-17
• Last Update Posted: 11 June 2024

Recruitment & Eligibility

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

Inclusion Criteria

- age between 18 and 70
- onychomycosis of one to three townails (per foot)
- between 10% and 75% affected area of the nail
- matrix of the nail not involved
- no 'spikes' of the affected nail

Exclusion Criteria

- pregnancy or breast feeding
- not able to give informed consent
- diabetes
- peripheral vascular disease
- malignancy
- mycosis of the whole foot
- allergy to components of the treatments
- use of vitamin K antagonists, oral glucose lowering medication, phenytoin.
- oral treatment with antifungal medications in the past half year

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Cure of the index nail after 26 weeks with miconazole or amorolfine compared<br /><br>with non-active laque</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- percentage of healing (percentage and onycho severity index)<br /><br>- quality of life<br /><br>- side-effects<br /><br>- difference in effect between the three intervention groups</p><br>