Table 3.
Primary and secondary efficacy outcome measures (ITT population)
| BMV dressing | CBD ointment | Significance for the difference | |
|---|---|---|---|
| TSS-4 mean total score | |||
| Week 1 | 4.348 | 4.232 | P = 0.440 |
| Week 2 | 3.558 | 3.136 | P = 0.005 |
| Week 3 | 2.878 | 2.513 | P = 0.012 |
| Week 4 (primary endpoint) | 2.215 | 1.679 | P = 0.001 |
| 3-month follow-up | 2.215 | 1.676 | P = 0.001* |
| TSS-4 mean subscores at week 4 | |||
| Redness/erythema | 0.974 | 0.873 | P = 0.084 |
| Scale/crusting | 0.499 | 0.289 | P < 0.001 |
| Thickening/elevation | 0.603 | 0.437 | P = 0.009 |
| Pruritus | 0.142 | 0.073 | P = 0.072 |
| PGA mean score: Investigator rated | |||
| Week 1 | 2.446 | 2.394 | P = 0.420 |
| Week 2 | 2.135 | 2.018 | P = 0.097 |
| Week 3 | 1.927 | 1.784 | P = 0.057 |
| Week 4 | 1.454 | 1.295 | P = 0.073 |
| PGA mean score: Patient rated | |||
| Week 1 | 2.362 | 2.304 | P = 0.474 |
| Week 2 | 2.041 | 1.894 | P = 0.100 |
| Week 3 | 1.823 | 1.643 | P = 0.052 |
| Week 4 | 1.558 | 1.267 | P = 0.007 |
| DLQI mean total score | |||
| Week 1 | 6.046 | 5.781 | P = 0.462 |
| Week 2 | 5.041 | 4.590 | P = 0.232 |
| Week 3 | 3.949 | 3.603 | P = 0.315 |
| Week 4 | 3.717 | 2.908 | P = 0.022 |
| 3-month follow-up | 3.000 | 4.529 | P = 0.076† |
| TSS at 3 items mean total score | |||
| Week 4 | 2.665 | 2.309 | P = 0.016 |
| Target plaques surface area at week 4 (cm2) | 27.687 | 21.281 | P = 0.002 |
| Success/disappearance of active lesions at week 4 (% of patients) | |||
| PGA (investigator rated) | 46.1 | 55.3 | P = 0.057‡ |
| TSS-4 (investigator rated) | 45.5 | 56.6 | P = 0.039‡ |
| TSS-3 (assessor rated) | 17.6 | 23.3 | P = 0.185‡ |
| Relapse/rebound during follow-up | 14.5% | 19.5% | ND |
| Patients’ acceptability/satisfaction at week 4, VAS (mm) | 74.945 | 79.634 | P = 0.043§ |
Number of observations available for TSS-4 at 3-month follow-up: N = 72 and 81, in BMV and CBD group respectively.
Number of observations available for DLQI at 3-month follow-up: N = 71 and 81, in BMV and CBD group respectively.
Cochran–Mantel–Haenszel test, stratified by centre.
anova model, with treatment and centre as fixed effects.
Data are adjusted means from ancova model with the parameter as dependent variable, treatment and centre as fixed effects and baseline value as covariate, unless otherwise specified, with relevant P-value between treatment groups comparison.
BMV, betamethasone valerate dressing; CBD, calcipotriol–betamethasone dipropionate ointment; DLQI, dermatology life quality index; PGA, psoriasis global assessment; ITT, intention to treat; TSS, total severity score; VAS, visual analogue scale; ND, not done.