Methods |
RCT
Study aim clearly defined: yes
Blinded assessor of primary outcome: not stated
Double blind study; yes
Participants comparable at baseline for age: yes Sex: yes Duration of complaint: yes
Inclusion and exclusion criteria specified: yes
Interventions well described: yes
Assessment of compliance: not stated
Intention to treat analysis: yes
A Priori sample size calculation: not stated
Fungi identified: yes
Distribution of species between groups: yes
Adverse events reported: yes
Number of drop outs stated: yes |
Participants |
Total evaluable sample size: 211
Exclusion criteria: white superficial or proximal subungual onychomycosis. Nail dystrophy. Infection which led to epinychium, antifungal therapy 24 weeks prior to study. Treatment setting; Multicentre studies USA |
Interventions |
a. Ciclopirox nail lacquer 8% solution
Duration: 48 weeks
Frequency: applied once daily
b. Placebo solution
Duration: 48 weeks
Frequency: applied once daily: |
Outcomes |
Primary outcome: cure
Secondary Outcomes: Planimetric measurements % affected nail, Global evaluation score 0=cured, 1=excellent improvement, 2=moderate improvement; 3=slight improvement; 4= no change.
Adverse events: 10 (9%) group a,
7 (6%) group b. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Allocation concealment (selection bias) |
Unclear risk |
B ‐ Unclear |