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. 2021 Apr 19;2021(4):CD011535. doi: 10.1002/14651858.CD011535.pub4

Lowe 1991.

Study characteristics
Methods RCT, placebo‐controlled, double‐blind trial
Date of study: not stated
Location: 2 centres in Santa Monica and New York City, USA
Participants Randomised: 34 participants, age range 20 ‐ 75 years, 24 male
Inclusion criteria
  • Participants with moderate‐severe psoriasis

  • BSA 20 ‐ 80

  • ≥ 6 months duration


Exclusion criteria
  • Had received conventional systemic treatments or phototherapy for 4 weeks or topical therapy for 2 weeks


Dropouts and withdrawals
  • Not specified

Interventions Intervention
A. Acitretin (n = 16), orally, 50 mg, daily, 12 weeks
Control intervention
B. Placebo (n = 18), orally, daily, 12 weeks
Co‐intervention:
UVB (phototherapy)
Outcomes Assessments at 12 weeks
Primary outcomes of the trial
  • PASI


Secondary outcomes of the trial
  • Side effects

Notes Funding source (p 591): Quote: "Supported by Roche dermatologics, Nutley, New Jersey and the Skin Research Foundation of California, Santa Monica, California"
Declarations of interest; not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote (p 592): "Patients receiving UVB phototherapy were randomly assigned"
Comment: no description of the method used to guarantee random sequence generation
Allocation concealment (selection bias) Unclear risk Quote (p 592): "Patients receiving UVB phototherapy were randomly assigned"
Comment: no description of the method used to guarantee allocation concealment
Blinding of participants and personnel (performance bias)
All outcomes High risk Quote (p 592): "were randomly assigned to either acitretin or placebo"
Comment: no more precision however adverse effects of acitretin such as cheilitis are visible
Blinding of outcome assessment (detection bias)
All outcomes High risk Quote (p 592): "were randomly assigned to either acitretin or placebo... the same observer who was unaware of patient group examined the patients throughout the investigation"
Comment: no more precision but adverse effects of acitretin such as cheilitis are visible
Incomplete outcome data (attrition bias)
All outcomes Unclear risk 34 included / 34 analysed (Table 2)
Comment: no description of the method used to manage the missing data or to perform the analyses
Selective reporting (reporting bias) Unclear risk Comment: no protocol was available. The prespecified outcomes mentioned in the Methods section appeared to have been reported