Montana 1994.
| Methods | RCT (parallel) Study design: Double blind Sample size calculation: No Diagnosis mycology: KOH and culture Big toenail specified: No Statistical comparisons for outcomes: No Duration of follow‐up: At 2 months Time points of measurements: Months 6, 12 and 14 Location: unknown |
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| Participants | Total n: 20 Age: 18 to 75 years Sex: Unknown Inclusion criteria: Participants selected for the study were men and nonpregnant, nonlactating women between the ages of 18 and 75 with a clinical and mycologic diagnosis of distal subungual onychomycosis. A target toenail was chosen and was required to have at least 25% healthy nail. Exclusion criteria: People with psoriasis, lichen planus, or other diseases that may affect the nails or people with significant systemic disease were excluded. Other exclusion criteria included known hypersensitivity to any of the ingredients of the medications, use of a topical antifungal medication within 1 month, or systemic medication within 3 months prior to screening Disease duration: Unknown Comparable at baseline: Unknown Causative species: Unknown Number of participants lost to follow‐up: lack of efficacy of drug: n = 1, nondermatophyte infection (treatment failed): n = 1; study arm unknown Trial duration: unknown |
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| Interventions | Treatment duration: twice daily for 12 months Drug in study arm 1: Active Group fungoid tincture (triacetin, cetylpyridinium chloride and chloroxylenol), n = 10. Drug in study arm 2: Vehicle, n = 10 |
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| Outcomes | Mycological cure (KOH and culture) at months 6, 12 and 14 Adverse events: reported |
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| Notes | Quote: "This study was supported by a research grant from [industry], which supplied all test materials." | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "Patients were 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 | Unclear risk | Quote: "Neither the investigator nor the patients knew the type of medication that each patient received" Comment: Appears to be blinded, but no indication if treatments looked identical |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Comment: Blinded, but no specific mention of outcome assessor blinding method or who performed assessments |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "Two patients did not complete the study for reasons unrelated to the drug trial. They were replaced by two additional patients. One patient dropped out due to lack of efficacy of the drug. One of the patients...had a nondermatophyte infection" Comment: Treatment allocation of participants who did not complete the study not specified |
| Selective reporting (reporting bias) | High risk | Comment: Clinical outcomes are not defined clearly or reported. Study pre‐dates trial registry in the USA |
| Other bias | Low risk | Comment: Not a multiple intervention trial, all outcomes reported for interventions |