Phase 3 Trial Demonstrating High Efficacy, Favourable Safety, and Convenience of a Novel Calcipotriene and Betamethasone Dipropionate Cream
Year: 2023
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
Abstract: Also at week 4, the proportion of patients achieving PGA treatment success was higher in the CAL/BDP PAD-cream group (25.2%) compared to the vehicle group (0.6%) and numerically higher than the CAL/BDP TS/gel group (18.7%; p=0.0510) (Figure 2).• The patient reported PTCS score for CAL/BDP PAD-cream was rated superior to CAL/BDP TS/gel at week 8 (p<0.0001) and was also significantly higher at week 4 (p<0.0001),demonstrating that CAL/BDP PAD-cream has superior treatment convenience compared to CAL/BDP TS/gel.• The mean change in Dermatology Life Quality Index (DLQI) score from baseline to week 8 improved statistically significantly more in the CAL/BDP PAD-cream group compared to both vehicle (p<0.0001) and CAL/BDP TS/gel (p=0.0110)(Figure 3).A statistically significant difference was also observed at week 4 for CAL/BDP PAD-cream compared to vehicle (p<0.0001) and CAL/BDP TS/gel (p=0.0159)(Figure 3).• Safety assessments during the trial demonstrated that CAL/BDP PAD-cream was well-tolerated with all adverse reactions reported at a frequency below 1%.• Overall, 490 patients were randomised, 213 patients were in the CAL/BDP PADcream group, 209 patients were in the CAL/BDP TS/gel group, and 68 patients were in the cream vehicle group.Overall, all demographic characteristics were comparable between the three treatment groups (Table 1).• The percentage mean change from baseline to week 8 in mPASI for CAL/BDP PAD-cream (67.5%) was superior compared to vehicle (11.7%; p<0.0001) and non-inferior to CAL/BDP TS/gel (63.5%) (Figure 1). RESULTS
Language: English
Subfield: Dermatology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4324057408