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. 2019 Apr 26;2019(4):CD004055. doi: 10.1002/14651858.CD004055.pub2

Gupta 1993.

Methods Parallel‐group, randomised controlled trial
The study was conducted at a single dermatology centre in Canada
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
  • Corticosteroid‐responsive dermatitis limited to the hands


Exclusion criteria of the trial
  • Medically significant cutaneous conditions other than hand eczema

  • Clinically infected hand dermatitis

  • Known sensitivity to study medication

  • Use of topical corticosteroids in the last 14 days, other topical treatments in last week, systemic corticosteroids during last 12 weeks. Systemic antimicrobials, all other investigational drugs and radiation therapy last 30 days, systemic or topical antihistamines in last 14 days, and topical anaesthetics or topical and systemic analgesics in last 48 hours


Study population
  • Gender: not stated

  • Age: 18 to 70 years

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
Outcomes Primary outcomes of the trial
Not defined
Other outcomes
  • Investigator‐rated overall severity of hand eczema:(0 = absent, 1 = mild, 2 = moderate, 3 = severe) at days 2, 4, and 7

  • Investigator‐rated scores (0 = absent, 1 = mild, 2 = moderate, 3 = severe) of pruritus, scaling, erythema, induration at days 2, 4, and 7

  • Physician global assessment of eczema relief (+3 = cleared to ‐2 = much worse) at days 2, 4, and 7

  • Adverse events

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
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