Piérard-Franchimont 2002
| Methods | Individual randomised controlled trials | |
| Participants | Diagnosis: SebDerm or non-inflammatory dandruff as diagnosed by physician Age: 17 to 69 years; mean duration: Intervention (78.2), Control (77.8); previous treatment: Schwarzkopf shampoo; sex: keto (male 96/171), ZnPTO (male 105/160); mean duration: keto (78.2 months), ZnPTO (77.8 months) |
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| Interventions | Intervention: ketoconazole 2% shampoo applied to scalp 2× weekly for 28 days (n = 171) Control: zinc pyrithione 1% shampoo applied to scalp 2× weekly for 28 days (n = 176) |
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| Outcomes |
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| Notes | Country: Belgium Relapse rate: keto (60/155), ZnPTO (73/142); adverse effects: itching and erythema - keto (2%), ZnPTO (1%) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The subjects were then allocated ... according to a computer generated randomized code ..." |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Baseline comparable? | Low risk | "The subjects were then allocated ... according to a computer generated randomized code ..." "The demographic and baseline observations were similar in the 2 treatment groups" |
| Patient blinded? | High risk | The design part of the clinical trial was open because the 2 test formulations ... had different colours and smells |
| Provider blinded? | High risk | Open-label trial |
| Outcome assessor blinded? | High risk | Open-label trial |
| Co-interventions avoided? | Low risk | "... neutral Scarzkopf shampoo was allowed to be used as an additional shampoo ..." |
| Compliance acceptable? | Unclear risk | Table 3, page 437 |
| Drop-out acceptable? | Low risk | Table 3, page 437 |
| Selective outcome reporting acceptable? | Low risk | All outcomes were reported |
| ITT? | Unclear risk | "The efficacy analysis were carried out on both the intent-to-treat and on-protocol populations of randomized subjects" Results in Table 3 suggest a per protocol analysis, but it is unclear whether subsequent table and figure and results text refer to an ITT analysis |