Shuster 2005
| Methods | Multi-centre trial | |
| Participants | Diagnosis: SD of the scalp (physician diagnosis implied from context) Exclusion: psoriasis, asthma, diabetes Severity score approximately 9 for all groups |
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| Interventions | Intervention: 1% ciclopirox shampoo applied twice weekly to scalp for 28 days (n = 376) Control 1: vehicle shampoo applied 2× weekly to scalp for 28 days (n = 190) Control 2: 1% ciclopirox shampoo applied once weekly to scalp for 28 days (n = 376) |
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| Outcomes | Outcome: complete clearance | |
| Notes | Country: England, Austria, Germany, France No conflict of interest Side effects: seborrhoea, rhinitis, shock, skin ulcer, anxiety Numbers of cases in each group were not given, but overall 120 participants had side effects |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "Patients in segment A and segment B were randomized separately using different sets of randomization numbers." The research organization and sponsors held an identical set of envelopes. The randomization envelopes were not opened until the day of study |
| Allocation concealment (selection bias) | Low risk | See above |
| Baseline comparable? | Low risk | "... no difference in severity, no difference in duration of previous treatment" |
| Patient blinded? | Low risk | "The patients were required to use 2 applications per week strictly alternating the use of bottles A1 and A2" |
| Provider blinded? | Low risk | "The patients were required to use 2 applications per week strictly alternating the use of bottles A1 and A2" |
| Outcome assessor blinded? | Low risk | "The patients were required to use 2 applications per week strictly alternating the use of bottles A1 and A2" |
| Co-interventions avoided? | Low risk | "Patients were not allowed to receive concomitant topical treatment of the scalp or any non-systemic treatment..." |
| Compliance acceptable? | Unclear risk | Not reported |
| Drop-out acceptable? | Low risk | "4% overall ..." |
| Selective outcome reporting acceptable? | Low risk | All outcomes reported |
| ITT? | Low risk | Number of patients evaluated corresponds with the number randomly assigned |