Flori 1994.
Methods | This was a randomised, double‐blind, placebo‐controlled study. It was unclear if intention‐to‐treat analysis was conducted. |
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Participants |
Inclusion criteria of the trial
There were no dropouts or withdrawals during the study. Exclusion criteria of the trial
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Interventions |
Both active and placebo treatment were applied as a gel and micro‐emulsion. The gel was applied in the morning and the micro‐emulsion in the evening, 100 mg by finger, during 90 days. Every application was preceded with topical creme, which contained betamethasone 0.2% and 2% aminoglycoside antibiotic. |
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Outcomes |
Outcomes of the trial
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Notes | ‐ | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Participants were sequenced in a randomisation scheme." |
Allocation concealment (selection bias) | Unclear risk | Comment: The paper provided insufficient details. |
Blinding (performance bias and detection bias) Clinician/ Investigator | Low risk | Quote: "...double‐blind study." |
Blinding (performance bias and detection bias) Participants | Low risk | Quote: "...double‐blind study." |
Blinding (performance bias and detection bias) Outcome assessor | Low risk | Quote: "...double‐blind study." Comment: The blinded investigator was probably the assessor. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All participants completed the entire treatment course." Comment: The study reported no dropouts. |
Selective reporting (reporting bias) | High risk | Onychodystrophy toenails were reported in the placebo group. The treated group reported no toenails. There were no results for the placebo toenails. |
Other bias | Unclear risk | Puropharma supplied the Kevis nails delivery. |