NCT01246518.
| Methods | RCT (parallel) Study design: Open Sample size calculation: Unknown Diagnosis mycology: Culture Big toenail specified: Yes Statistical comparisons for outcomes: Unknown Duration of follow‐up: 9 and 3 months Time points of measurements: 12 months Location: 15 sites, Sweden (cities/institutions unknown) |
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| Participants | Total n: 250 Age: 18 ‐ 70 years of age Sex: Men and women (ratio unknown) Inclusion criteria: Clinical diagnosis of distal subungual onychomycosis (DSO) of at least 1 great toenail affecting 25% ‐ 75% nail, positive culture for a dermatophyte Exclusion criteria: Proximal subungual onychomycosis, DSO of both great toenails where unaffected proximal nail is less than 2 mm, spikes, dermatophytoma, oral and topical antifungal use within 3 and 1 month of screening, respectively, signs of severe peripheral circulatory insufficiency, immunosuppression, participation in a clinical trial during the previous 4 weeks, known allergies to treatment products, pre‐menopausal women who are pregnant or nursing, not surgically sterile, or not practicing acceptable birth control Disease duration: Unknown Comparable at baseline: Unknown Causative species: dermatophytes Number of people lost to follow‐up: Unknown Trial duration: December 2010 ‐ October 2012 |
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| Interventions | Drug in study arm 1: MOB015 once a day for 3 months, n = unknown Drug in study arm 2: MOB015 once a day for 9 months, n = unknown |
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| Outcomes | Mycologic cure (negative microscopy and culture) at 12 months Proportion of participants with negative culture, negative microscopy, and complete cure at 1, 3, 6, 9, and 12 months Adverse events: not reported |
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| Notes | Industry provided financial support. Last update posted on clinicaltrials.gov: 25 October 2012; Email correspondence: Data are not available. Phase 3 trials with this agent are ongoing, NCT02859519 and NCT02866032 | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Email response: "randomisation using the method of randomly permuted blocks." Comment: Method of randomisation appropriate |
| Allocation concealment (selection bias) | Low risk | Email response: "randomisation lists will be prepared by [a third party]...group will be allocated in the web‐based e‐CRF provided by [the third party]" Comment: Allocation concealment appropriate |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: Open‐label study |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: Open‐label study |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: No information in trial registry |
| Selective reporting (reporting bias) | High risk | Comment: Outcome (complete cure) provided in clinical trial register not defined |
| Other bias | Unclear risk | Comment: Not a multiple treatment arm study, but there are no results to assess |