To study the effect of local antifungal treatment of the toenails
ID
Source
Brief title
Condition
- Skin appendage conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Cure of the index nail after 26 weeks with miconazole or amorolfine compared
with non-active laque
Secondary outcome
- percentage of healing (percentage and onycho severity index)
- quality of life
- side-effects
- difference in effect between the three intervention groups
Background summary
Fungal infections of the toenails are frequently seen by patients and doctors.
It is unknown what the effectiveness is of local antifungal therapy.
Study objective
To study the effect of local antifungal treatment of the toenails
Study design
Randomised controlled clinical trial
Intervention
1) Miconazole laque, 2) Amorolfine laque, 3) Laque without antifungal effect
(Byte-x).
Study burden and risks
The two active substances used for this trial are approved for sale on the
European market for this indication. We do not expect any negative health
effects of the interventions. The only side-effects known are local skin
irritation, which disappears after stopping the intervention. Participants are
asked to fill in questionnaires three times during the study. We feel that the
burden and risks associated with participation are ethically sound.
Albinusdreef 2
Leiden 2300RC
NL
Albinusdreef 2
Leiden 2300RC
NL
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2019-000335-77-NL |
| CCMO | NL68851.058.19 |
| OMON | NL-OMON26092 |