Kragballe 1991.
Methods | Randomised, open, prospective, right‐left comparative trial Number of centres not stated Period of inclusion not stated |
|
Participants |
Inclusion criteria
Exclusion criteria
Baseline data: randomised comparison of Actiderm plus triamcinolone acetonide 0.1% cream applied every third day (19) vs clobetasol 0.1% cream applied twice daily (19)
Withdrawal: no dropouts |
|
Interventions |
Intervention 1 A: Actiderm plus triamcinolone acetonide (TAA) 0.1% cream every third day (19 participants) Intervention 2 B: clobetasol 0.05% cream twice per day (19 participants) Co‐interventions: none Duration of treatment: 4 weeks |
|
Outcomes | No primary or secondary outcome pre‐specified
Outcomes were evaluated at each visit (‐2, 0, 2, 4, and 8 weeks) |
|
Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "This was a randomised comparison" Comment: insufficient information about the sequence generation process to permit judgement |
Allocation concealment (selection bias) | Unclear risk | Comment: no information on method to guarantee allocation concealment |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "Actiderm plus TAA 0.1% cream was replaced every third day. Clobetasol 0.05% cream was applied twice daily" Comment: no evidence of blinding, which is very difficult in this case |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Comment: no evidence of blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Comment: no mention of missing data |
Selective reporting (reporting bias) | High risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results and not all outcomes cited in the methods were reported in the results (skin atrophy) |