Dreno 2003
| Methods | Individual randomised controlled trials | |
| Participants | Dx: facial seborrhoeic dermatitis of at least 2 months' duration in male and female patients between 18 and 65 years of age; moderate to severe redness and scaling. Physician diagnosis implied from context Exclude patients with allergy to test products; patients with scalp SD requiring therapy; patients with Parkinson's disease, HIV, ear, nose and throat cancer, and with severe recurrent illness Sex: lithium (male - 63.8%), keto (male - 63.2%); age: lithium (39.2 ± 11.7), keto (41.3 ± 11.2); duration: lithium (3.5 ± 1.0 years), keto (3.6 ± 0.9 years); previous treatment: lithium (75%), keto (72.8%) |
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| Interventions | Int: Lithium gluconate 8% applied twice daily for 8 weeks (n = 152) Control: ketoconazole 2% emulsion applied twice weekly to face for 28 days and then once weekly for the next 28 days (n = 136) |
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| Outcomes |
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| Notes | Country: France; COI: sponsorship by Laboratoire Labcatal, producer of the brand of lithium gluconate used Sample size derivation was elucidated; compliance with regimen was also a study objective; side effects: lithium (26.3%), keto (25%) |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "The randomization method used computer generated blocks .." |
| Allocation concealment (selection bias) | Low risk | "The randomization code was concealed in sealed envelopes ..." |
| Baseline comparable? | Low risk | See Table 1 |
| Patient blinded? | Low risk | "Investigators provided patients with sealed boxes ... these boxes were similar in appearance ..." |
| Provider blinded? | Low risk | "Investigators provided patients with sealed boxes ... these boxes were similar in appearance ..." |
| Outcome assessor blinded? | Low risk | "The randomization code was concealed in sealed envelopes ..." |
| Co-interventions avoided? | Unclear risk | Not reported |
| Compliance acceptable? | Low risk | 80% compliance with protocol: lithium (93.3%), keto (93%) |
| Drop-out acceptable? | Low risk | Lithium (17/152), keto (17/136) |
| Selective outcome reporting acceptable? | Low risk | All outcomes were reported |
| ITT? | Low risk | Number of participants evaluated corresponds with the number randomly assigned. Refer to Figures 4, 5 and 6 |