Table 2.
References | Study identifier | Design | Duration (weeks) | N | Comparator(s) | Outcomes |
---|---|---|---|---|---|---|
Queille-Roussel [49] | NCT01347255 | Phase IIa, exploratory, single-center, intra-individual comparison | 4 | 24 | Cal/BD foam vs. Cal/BD ointment vs. BD foam vs. foam vehicle (all n = 24) | TCS decrease: −6.00 vs. −5.25 (Cal/BD ointment; P = 0.038), vs. −4.96 (BD foam; P = 0.005) |
Koo et al. [51] | NCT01536886 | Phase II, randomized, multicenter | 4 | 376 | Cal/BD foam (n = 141) vs. Cal/BD ointment (n = 135) vs. foam (n = 49) and ointment (n = 51) vehicle | Treatment success rates: 54.6% vs. 43.0% (Cal/BD ointment; P = 0.025); mPASI mean difference: −0.6 vs. Cal/BD ointment (P = 0.005) |
Paul et al. [52] | NCT02132936 | Phase III, randomized, parallel-group (PSO-ABLE) | 12 | 463 | Cal/BD foam (n = 185) vs. Cal/BD gel (n = 188) vs. foam (n = 47) and gel (n = 43) vehicle | Treatment success rates: 38% vs. 22% (Cal/BD gel; P < 0.001); mPASI mean difference: −0.6 vs. Cal/BD gel (P = 0.028) |
Paul et al. [53] | NCT02132936 | Phase III, randomized, parallel-group (PSO-ABLE secondary, HRQoL analysis) | 12 | 463 | Cal/BD foam (n = 185) vs. Cal/BD gel (n = 188) | DLQI scores of 0/1: 61% vs. 44% (Cal/BD gel; P = 0.003); EQ-5D utility index: 0.09 vs. 0.03 (Cal/BD gel; P < 0.001) |
All studies were investigator-blinded
BD bethamethasone dipropionate 0.5 mg/g, Cal calcipotriol 50 μg/g, DLQI Dermatology Life Quality Index, EQ-5D EuroQoL-5D-5L-PSO, HRQoL health-related quality of life, mPASI modified Psoriasis Area and Severity Index (excluding the head, which was not measured), TCS total clinical score (sum of erythema, scaling and plaque thickness)