Stein 2014.
| Methods | RCT (parallel) Study design: Double blind Sample size calculation: Unknown Diagnosis mycology: KOH and culture Big toenail specified: Yes Statistical comparisons for outcomes: Unknown Duration of follow‐up: 4 weeks Time points of measurements: Week 52 Location: United States (city/institution unknown) |
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| Participants | Total n: 334 Age: 18 ‐ 70 years of age, inclusive Sex: Men and women (ratio unknown) Inclusion criteria: Adult men and women, any race, 18 ‐ 70 years of age with a clinical diagnosis of mild‐to‐moderate distal subungual onychomycosis, 25% ‐ 50% nail involvement and positive KOH and culture. Participants had to be free of disease that in the investigator's opinion might interfere with study evaluations or jeopardise patient safety Exclusion criteria: History of intolerance or hypersensitivity to imidazole compounds or the inactive components of the solution. Current or recent participation in another investigational medication or device study Disease duration: Unknown Comparable at baseline: Unknown Causative species: Unknown Number of participants lost to follow‐up: Unknown Trial duration: unknown |
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| Interventions | Drug in study arm 1: Luliconazole solution, 10% once daily for 48 weeks, n = unknown Drug in study arm 2: Vehicle solution, once daily for 48 weeks, n = unknown Drug in study arm 3: Luliconazole solution, 10% once daily for 12 weeks, followed by once weekly for 36 weeks, n = unknown Drug in study arm 4: Vehicle solution, 10% once daily for 12 weeks, followed by once weekly for 36 weeks, n = unknown |
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| Outcomes | Complete cure at week 52 Adverse events: reported |
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| Notes | Conference abstract of interim results so demographics limited. 1 of 6 authors has industry affiliation. Study supported by industry | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "patients have been randomised" 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 | Unclear risk | Comment: No information was available |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: No information was available |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: No information was available |
| Selective reporting (reporting bias) | Low risk | Comment: Efficacy outcomes stated in trial protocol also stated in abstract. NCT01431820 |
| Other bias | Unclear risk | Comment: Multiple treatment arms, but interim abstract of study's progress and no results to assess |