Local antimycotic treatment of fungal toenail infection is more effective than placebo
ID
Source
Brief title
Condition
- Fungal infectious disorders
Synonym
Health condition
Onychomycosis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Complete cure, consisting of both clinical and mycological cure of the index toenail at 6 months
Secondary outcome
Clinical improvement (defined as either ≤10% involvement of the index toenail or as ≥40% reduction)
Symptom burden as expressed by the ONYCHO questionnaire score
Quality of life based on the Short Form-12 survey
Adverse effects
Therapy compliance
Patient-perceived improvement
Treatment acceptability
Background summary
Fungal infection (onychomycosis) of the nails is a common ailment seen in GP practice, often found to be annoying and unsightly. In most cases it involves the greater toenail. The only clinically proven effective treatment is oral terbinafine or an imidazole for at least 3 months. GP's and dermatologists regard onychomycosis primarily as a cosmetic problem and not so much a medical one, therefore understandably being hesitant or reluctant to prescribe oral terbinafine. If treatment is chosen for more extensive forms of onychomycosis, oral therapy remains first choice however. With less severe, more limited forms of onychomycosis, local therapy might be a good alternative. If proven effective, this could lead to fewer prescriptions of oral terbinafine which is desirable given the rare but potentially serious side effects. A recent Cochrane Review states that more research into the effectiveness of local treatment is needed. Little research has been done into one of the most frequently used antimycotic agents in the Netherlands, miconazole. Given the already proven effectiveness and potential side effects of terbinafine orally, this study focus is on comparing the two most commonly used topical agents (miconazole and amorolfine) versus placebo. The aim of this study is to investigate the effect of local treatment of onychomycosis of the toenail(s) with miconazole or amorolfine as compared to placebo.
Study objective
Local antimycotic treatment of fungal toenail infection is more effective than placebo
Study design
Total treatment and follow-up of 6 months
Intervention
Miconazole; Amorolfine
Roeland Michiel Watjer
Albinusdreef 2
2333 ZA
Leiden
The Netherlands
onderzoekscentrum.pheg@lumc.nl
Roeland Michiel Watjer
Albinusdreef 2
2333 ZA
Leiden
The Netherlands
onderzoekscentrum.pheg@lumc.nl
Age
Inclusion criteria
1. Age 18 - 70 years
2. Onychomycosis of 1 up to a maximum of 3 nails per foot
3. Limited form of onychomycosis, defined as at least 10% and not more than 75% of the nail
(visually) affected
4. No involvement of the matrix
5. No spikes
Exclusion criteria
1. Known allergy or hypersensitivity for one of the study medications
2. Pregnancy or lactation
3. Presence of malignancy
4. Generalized fungal infection of the (rest of) the foot
5. Patients treated with oral antimycotic therapy within the last 6 months
6. Use of vitamin-K antagonists, oral antidiabetics and/or phenytoin
7. Peripheral arterial occlusive disease stages III and IV
Design
Recruitment
IPD sharing statement
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8193 |
| CCMO | NL68851.058.19 |
| EudraCT | 2019-000335-77 |
| OMON | NL-OMON52904 |