Gupta 1993.
Methods | Parallel‐group, randomised controlled trial The study was conducted at a single dermatology centre in Canada |
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Participants | 58 participants with steroid‐responsive dermatitis limited to the hands Evaluable: 54 Dropouts: 6, of whom 4 permitted a protocol violation and 2 ended prematurely because of an exacerbation of hand eczema Inclusion criteria of the trial
Exclusion criteria of the trial
Study population
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Interventions |
Intervention • Betamethasone dipropionate film‐forming lotion in 28/29 participants daily for 7 days • Betamethasone dipropionate thickened lotion in 26/29 participants for 7 days Duration 1 week |
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Outcomes |
Primary outcomes of the trial Not defined Other outcomes
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Notes | Very short study of only 7 days. Unclear about withdrawals in lotion group. Exact number allocated to each treatment not specified. Among the different outcomes, unclear how change in overall severity was calculated Declarations of interest: not stated. Funding: the study was supported in part by a grant from GenDerm Corporation, Montreal, Canada, manufacturer of the study drugs Sample size rationale: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "participants were randomly assigned to 2 groups..." Comment: no further details |
Allocation concealment (selection bias) | Low risk | Quote: "bottles were dispensed in their marketed containers with identical overlabels and the contents were not known to the patients or the investigator who assessed the results. Only the study coordinator was aware of the contents of the bottles" Comment: sequentially numbered drug containers of identical appearance are considered as adequate allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "bottles were dispensed in their marketed containers with identically appearing overlabels and the contents were not known to the patients or the investigator who assessed the results. Only the study coordinator was aware of the contents of the bottles" Comment: double‐blind study; identical looking containers were used |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "bottles were dispensed in their marketed containers with identically appearing overlabels and the contents were not known to the patients or the investigator who assessed the results. Only the study coordinator was aware of the contents of the bottles" Comment: observers were unaware of the study drug, which was identical in appearance |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No intention‐to‐treat analysis but per protocol (54 or 52 of 58 = more than 80%) |
Selective reporting (reporting bias) | Unclear risk | No trial registration found. No major differences between the Methods and Results sections found; however for erythema and pruritus, study authors state only that no significant differences were found |
Other bias | Low risk | Baseline comparisons: at baseline, significant differences in scaling between groups, but controlled for by statistical procedure. No significant differences at baseline with regard to age, gender, race, erythema, induration, pruritus, or area of eczematous involvement Diagnostic certainty: yes The study was completed |