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Effectiveness of local treatment for onychomycosis

Effectiveness of local treatment for onychomycosis - Local onychomycosis treatment

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON52904
Enrollment
113
Registered
2019-08-26
Start date
2020-02-10
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fungal infection of the nail

Interventions

1) Miconazole laque, 2) Amorolfine laque, 3) Laque without antifungal effect (Byte-x).

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Cure of the index nail after 26 weeks with miconazole or amorolfine compared with non-active laque

Secondary

MeasureTime frame
- percentage of healing (percentage and onycho severity index) - quality of life - side-effects - difference in effect between the three intervention groups

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)