Rosen 1987.
Methods | Placebo‐controlled, randomised, within‐participants study Number of centres not stated Period of inclusion not stated |
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Participants |
Inclusion criteria
Exclusion criteria
Clinical situation was assessed by the same investigator (KR) before treatment (2 weeks), after 2 weeks (0 weeks), and then every 3 weeks by judging the severity of lesions on either side Baseline data: randomly allocated to etretinate 0.6 mg/kg/d (23 palms/soles) or placebo (14 palms/soles) or etretinate 0.6 mg/kg/d and PUVA therapy 3 times per week (23 palms/soles) or PUVA therapy 3 times per week (14 palms/soles)
Withdrawal: 7 participants were lost because of adverse events (5 in the etretinate/etretinate + PUVA therapy group: reasons for ending therapy were suddenly increased light sensitivity, with development of bullae on the feet, in combination with dry and scaly dermatitis, itching, and cheilitis (2 participants); extreme dryness of the skin and mucous membranes (1 participant); pain under all fingernails after 3 weeks of etretinate treatment (no UVA to the hands), without signs of paronychia (1 participant); and thrombophlebitis on the lower leg, considered unrelated to therapy (2 participants and 2 in the placebo/PUVA therapy group). One placebo‐treated participant withdrew from the trial because he did not tolerate the psoralen tablets, and another because he could not return regularly |
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Interventions |
Randomisation of participants to etretinate vs placebo, then for each group randomisation of 1 side (UVA irradiation or not) Intervention 1 A: oral etretinate twice per day (0.6 mg/kg/d) (23 palms/soles) Intervention 2 B: placebo (14 palms/soles) Intervention 3 C: oral etretinate (0.6 mg/kg/d) + UVA (3 times per week) (23 palms/soles) Intervention 4 D: UVA irradiation (3 times per week) (14 palms/soles) Co‐interventions: none Duration of treatment: 14 weeks |
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Outcomes | No primary or secondary outcome pre‐specified
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Notes | AB Draco, Lund, Sweden, provided the methoxsalen (Puvamet) tablets; and AB Hoffmann‐La Roche, Skärholmen, Sweden, the etretinate (Tigason) tablets | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Quote: "The patients were allocated to treatment groups according to year of birth (even or odd)" Comment: non‐random component in the sequence generation process |
Allocation concealment (selection bias) | High risk | Quote: "The patients were allocated to treatment groups according to year of birth (even or odd)" Comment: participants and investigators could foresee assignments |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "placebo‐controlled" Comment: placebo‐controlled but obvious side effects of etretinate, especially mucocutaneous side effects (dry lips and skin) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "placebo‐controlled" Comment: placebo‐controlled but obvious side effects of etretinate, especially mucocutaneous side effects (dry lips and skin) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Quote: "7 patients were lost because of adverse events (5 in the etretinate/etretinate +PUVA group: the reasons for ending therapy were suddenly increased light sensitivity, with development of bullae on the feet in combination with dry and scaly dermatitis, itching, and cheilitis (two patients); extreme dryness of the skin and mucous membranes (one patient); pain under all fingernails after three weeks of etretinate treatment (no UVA to the hands), without signs of paronychia (one patient); and thrombophlebitis on the lower leg, considered unrelated to therapy (one patient) and 2 in the placebo/PUVA group: One placebo treated patient withdrew from the trial because he did not tolerate the psoralen tablets, and another because he could not return regularly). The number of treatment‐related dropouts in the two groups was not statistically different" Comment: more than 10% of participants dropped out and there was no ITT analysis |
Selective reporting (reporting bias) | Unclear risk | Comment: no protocol found to guarantee that all planned outcomes are presented in the results |