Menter 2009.
Methods | DESIGN Between‐patient Participant delivery ALLOCATION Random Method of randomisation: not reported Concealment: unclear BLINDING Open (blinding NS but product vehicles differ) WITHDRAWAL/DROPOUT Described | |
Participants | N: 122
Treatment duration: 4 wks; FU: 8 wks
LF: 0 (0%)
BC: yes
Age: 46.5 (14.2SD)
Gender (per cent men): 61.1%
Duration (yrs): 16.4 (11.50SD)
Severity: ODS = 3.06 (0.43SD)
(participant demographics based on per‐protocol sample). INCLUSION CRITERIA
EXCLUSION CRITERIA
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Interventions |
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Outcomes |
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Notes | Galderma Laboratories, LP, sponsored the trial. Atrophy was not assessed. Telangiectasia was not assessed. 29 participants were 'non‐compliant' with treatment, but intention‐to‐treat (ITT) analysis included all enrolled participants. The sponsor supplied unpublished data. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | The trial reported insufficient details. |
Blinding (performance bias and detection bias) All outcomes | High risk | The trial was open (blinding not reported, but product vehicles differ). |
Randomisation method reported | Unclear risk | The trial did not report this. |
Loss to follow up | Low risk | 0% |
Baseline assessments | Low risk | These were reported. |
Baseline comparability demonstrated | Low risk | This was demonstrated. |