Rigopoulos 2007.
Methods | This was a randomised, double‐blind, actively‐controlled study. It was unclear if intention‐to‐treat analysis was conducted. |
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Participants |
Inclusion criteria of the trial
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Interventions |
Occlusion was performed after application of the cream using common transparent membrane obtained through general stores. |
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Outcomes |
Outcomes of the trial
Follow‐up evaluation was performed 12 weeks after the end of the therapy. |
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Notes | A 12‐week wash‐out period was allowed for topical and systematic medications. 3 of 16 participants in the tazarotene group reported adverse events: desquamation and erythema of nail fold skin, periungual irritation, paronychia, and irritation of the skin of the toe or finger distanced from the nail area. 1 of 14 participants in the clobetasol group reported a sensation of burning on the nail fold skin. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "The participants were randomly assigned by a computer." Comment: This was probably done. |
Allocation concealment (selection bias) | Low risk | Quote: "...assignment by a computer." Comment: This was probably done. |
Blinding (performance bias and detection bias) Clinician/ Investigator | Low risk | Quote: "...double blind study, investigators were blinded regarding the agent applied by each participant." |
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 outcome assessor. |
Incomplete outcome data (attrition bias) All outcomes | High risk | There were 16 dropouts (7 in the tazarotene group, and 9 in the clobetasol group): 10/16 had urgent need for systemic therapy; 4 of 16 failed to keep to the follow‐up schedule; and 2 had missing outcome data. |
Selective reporting (reporting bias) | Low risk | All of the expected outcomes were reported. |
Other bias | Unclear risk | There was no information about baseline characteristics. Both agents were given in identical containers. |