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. 2020 Jan 20;2020(1):CD011628. doi: 10.1002/14651858.CD011628.pub2

Muro 2016.

Methods Randomised, within‐patient study (left, right)
One centre in Tokyo
Period of inclusion: August 2010 to November 2012
Participants Inclusion criteria
  • Any phototherapy or systemic therapy begun before treatment would be continued without any change to the dosage regimen


Exclusion criteria
  • Had received phototherapy, ciclosporin, etretinate, methotrexate, oral corticosteroids, topical vitamin D3, or a topical corticosteroid classified as very strong before the start of the study


Baseline data: treatment sites were randomised to maxacalcitol + betamethasone butyrate propionate ointments or betamethasone butyrate propionate ointment alone
  • Mean age, years: 53

  • Male/female: 6/21

  • Mean duration of disease, years: 9.9

  • Proportion of participants with psoriatic lesions elsewhere: not specified

  • Severity at baseline on each randomised and treated side not specified


Withdrawal: 2 participants did not return to our hospital after the start of the study; 4 did not visit at week 8; 2 changed therapeutic strategy
Interventions Intervention 1
A: maxacalcitol ointment (Oxarol ointment 25 mg/g; MXA) (27 participants, within‐participant design)
Intervention 2
B: no treatment (27 participants, within‐participant design)
Co‐interventions: betamethasone butyrate propionate ointment (Antebate ointment 0.05%; BBP). In addition, any phototherapy or systemic therapy begun before treatment would be continued without any change to the dosage regimen
Duration of treatment: 8 weeks
Seven out of 27 participants received a concomitant therapy during the study:
 ‐ Methotrexate (n = 2)
 ‐ Etretinate (n = 2)
 ‐ Local bath‐PUVA (n = 1)
 ‐ Etretinate, local bath‐PUVA (n = 1)
 ‐ Etretinate, methotrexate (n = 1)
Outcomes No primary or secondary outcome pre‐specified
  • Modified PPPASI (palmoplantar pustular psoriasis area and severity index)

Notes Funding: not reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote: "The type of therapy was randomly assigned"
Comment: no precision
Allocation concealment (selection bias) Low risk Quote: "The type of therapy was randomly assigned via the sealed envelope method"
Comment: probably done
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "On one side two topical treatments were applied whereas on the other just one was applied making the blinding impossible "
Comment: blinding impossible
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "No double blind"
Comment: no blinding was done
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "Twenty one patients were completed"
Comment: 21 participants completed the study instead of 29, and study authors did not include 27 in the analysis ‐ only 21
Selective reporting (reporting bias) Unclear risk Comment: no protocol found to guarantee that all planned outcomes are presented in the results