Bonhert 2019.
| Methods | RCT (parallel) Study design: Open (evaluating investigator blinded) Sample size calculation: No Diagnosis mycology: KOH and culture Big toenail specified: Yes Statistical comparisons for outcomes: Yes Duration of follow‐up: At 4 weeks Time points of measurements: Weeks 48, 52 Location: United States of America (city/institution not stated) |
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| Participants | Total n: 30 Age: Mean 51 (range 29 ‐ 69) Sex: unknown (authors state men = 18, women = 13) Inclusion criteria: Patients 18 ‐ 70 years of age with a clinical diagnosis of DLSO affecting at least 1 great toenail. Toenail had to be uninfected length of 3 mm or more from the proximal nail fold and 3 mm or less in thickness. Diagnosis confirmed with positive KOH microscopy and positive culture of dermatophytes or mixed dermatophyte/Candida ≤ 42 days before baseline. Contraception and negative pregnancy test for women required Exclusion criteria: Use of laser/light‐based fungal therapy within 3 months, or topical antifungal therapy applied to the foot or nails within 1 month of study entry. HIV‐positive, infection, tinea pedis, immunosuppression and liver toxicity, non‐dermatophyte infection, and intolerance to efinaconazole were also excluded Disease duration: Unknown Comparable at baseline: Clinical index of onychomycosis was similar between the 2 groups Causative species: Dermatophytes or mixed dermatophyte/Candida Number of people lost to follow‐up: None Trial duration: unknown |
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| Interventions | Treatment duration: daily for 48 weeks, laser treatment every 4 weeks for 6 treatments at the beginning of the study in conjunction with daily topical use Drug in study arm 1: Efinaconazole 10% solution, n = 15 Intervention in study arm 2: Efinaconazole 10% solution and 1064 nm Nd:YAG laser, n = 15 |
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| Outcomes | Complete cure (negative KOH and culture, and 0% nail involvement with no onycholysis and subungual hyperkeratosis) at week 52 Effective treatment (negative KOH and culture, and ≤ 10% nail involvement) at week 52 KOH and fungal cultures at weeks 48 and 52 Adverse events: reported Participant satisfaction |
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| Notes | The study was funded by industry. There is no conflict of interest statement for authors. Author affiliations are academic in nature | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Quote: "randomised" Comment: Method of randomisation not specified |
| Allocation concealment (selection bias) | Unclear risk | Comment: No information was provided |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: The differences in treatment application (topical vs laser + topical) indicates that participants and personnel were probably not blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "evaluating investigator blinded"; "efficacy assessments will be performed on the target nail for each subject by the same blinded evaluating investigator" Comment: Blinding was adequate |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All 30 patients enrolled completed the study and adhered to the protocol." Comment: All participants were accounted for. |
| Selective reporting (reporting bias) | High risk | Comment: Outcomes stated in Methods are not reported in the Results (complete cure, adverse events) |
| Other bias | Low risk | Comment: Not a multiple intervention trial, but outcomes are reported for all interventions |