Layton 1991.
Methods | Placebo‐controlled trial, within participants Number of centres not stated Period of inclusion not stated |
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Participants |
Inclusion criteria
Exclusion criteria Not stated Baseline data: topical PUVA therapy (26 soles; 18 palms) vs placebo (26 soles; 18 palms)
Withdrawal: no dropouts |
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Interventions |
Intervention 1 A: 0.75% 8‐methoxypsoralen in hydrophilic water/oil emulsion and UVA phototherapy 3 times per week (N = 26 soles; 18 palms) Intervention 2 B: placebo (hydrophilic water/oil emulsion before UVA phototherapy, with a Perspex plate inserted between palm/sole and UVA light source) 3 times per week (N = 26 soles; 18 palms) Co‐interventions: none Duration of treatment: 8 weeks |
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Outcomes | No primary or secondary outcome pre‐specified
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Notes | Funding: not reported | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "At the initial visit each side was randomly allocated active or placebo therapy" 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 | Unclear risk | Quote: "To the placebo‐treated side, the emulsion base only was applied for 10 min prior to exposure to the light source. A Perspex plate was inserted between the palm/sole and the UVA light source at the placebo‐treated side. These procedures were carried out so that the patient was unaware which side received active treatment" Comment: patients were probably blinded; however no details regarding blinding of personnel, so hence the risk is unclear |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "To the placebo‐treated side, the emulsion base only was applied for 10 min prior to exposure to the light source. A Perspex plate was inserted between the palm/sole and the UVA light source at the placebo‐treated side" Comment: no details on how the assessor was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Quote: "All the patients had treatment three times a week over the course of 8 weeks and all completed the trial" Comment: no missing outcome data |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |