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. 2015 Apr 29;(4):CD008138. doi: 10.1002/14651858.CD008138.pub2

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%)
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)
Outcomes
  • Complete remission of rashes


  • Percentage clearance of redness, itching and scaling

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%)
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