Schalka 2012.
| Methods | RCT (parallel) Study design: Single blind Sample size calculation: No Diagnosis mycology: KOH and culture Big toe specified: Yes Statistical comparisons for outcomes: Yes Duration of follow‐up: At 5 and 180 days Time points of measurements: Days 60, 120 and 180 Location: unknown |
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| Participants | Total n: 41 Age: Average (range): Group 1 41.2 years (18 ‐ 63), Group 2 41.2 years (19 ‐ 65) Sex: Group 1: men 5/20 (25%), women 15/20 (75%). Group 2: men 1/21 (5%), women 20/21 (95%) Inclusion criteria: Men and women, 18 ‐ 65 years of age with distal or lateral subungual onychomycosis of the first right or left toe, between 10% ‐ 50% involvement of the nail plate and without matrix involvement Exclusion criteria: Unknown Disease duration: Average, median ± SD (range): Group 1: 22.3 months, 12 ± 26.7 months (6 ‐ 120); Group 2: 18.2 months, 12 ± 17.5 months (3 ‐ 84) Comparable at baseline: The presence of fungus on the baseline evaluation was similar in both treatment groups. When analysing the results in terms of the population evaluated we noticed a homogeneous distribution between the 2 groups, in terms of sex, age, involved area, proportion of affected nail, time of evolution and previous treatments, this way reducing the interference of these characteristics on the interpretation of the results Causative species: Predominance of the Trichophyton genus, the Trichophyton rubrum and Trichophyton mentagrophytes being represented, respectively, in 55.0% and 30% of the people that used the posology of once a week (group I), and in 61.9% and 19% of those of the 3/2/1 regimen (Group 2). The other species identified were Scytalidium dimidiatum and Candida albicans with a frequency of < 10% Number of participants lost to follow‐up: 0 Trial duration: unknown |
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| Interventions | Drug in study arm 1: Ciclopirox nail lacquer daily for 6 months, n = 20 Drug in study arm 2: Ciclopirox nail lacquer 3/2/1 (3 x a week in the first month, twice weekly for the second month and weekly till the end of the sixth month), n = 21 |
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| Outcomes | Mycological cure (negative culture) at days 60, 120 and 180 Therapeutic success (negative culture and clinical improvement > 90% of the healthy nail) at days 60, 120 and 180 Clinical improvement (negative culture and improvement between 50% and 90% of the affected nail and the percentage of improvement of the extension of the affected nail) at days 60, 120 and 180 Adverse events: reported |
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| Notes | All 3 authors have ties to industry (e.g. consultant, speaker). Grant for performing the study were received from industry | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomly assigned" Comment: Method of randomisation not specified |
| Allocation concealment (selection bias) | Unclear risk | Comment: No information was available |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: This is a single‐blind study comparing 2 different regimens of the same therapeutic agent. Participants were aware of treatment |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: It is possible that outcome assessors were blinded (single‐blind study). This is not explicitly stated in the article |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Comment: All participants completed the study |
| Selective reporting (reporting bias) | Unclear risk | Comment: Review authors were unable to find a clinical trial register entry for this study |
| Other bias | Low risk | Comment: Not a multiple intervention trial, with all outcomes reported for interventions |