Journal of Clinical and Aesthetic Dermatology

APR 2018

An evidence-based, peer-reviewed journal for practicing clinicians in the field of dermatology

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18 JCAD JOURNAL OF CLINICAL AND AESTHETIC DERMATOLOGY April 2018 • Volume 11 • Number 4 O R I G I N A L R E S E A R C H serious TEAE (diabetes mellitus, not related to the study treatment) and one subject (1.1%) discontinued the study due to TEAEs of application site pain and application site pruritus (both assessed as probably related to the study treatment). In subjects treated with vehicle lotion, there were no serious TEAEs, but two subjects (4.7%) discontinued the study due to TEAEs of application site pain and application site pruritus (assessed as possibly related to the study treatment). Two serious TEAEs were reported for two subjects (2.2%) in the augmented BD lotion 0.05% group. These serious TEAEs consisted of urinary tract infection, fall, hyponatremia, metabolic acidosis, convulsion, and alcohol withdrawal syndrome in one subject and an exacerbation of chronic obstructive pulmonary disease in the second subject (all assessed as not related to the study treatment). No subjects in the augmented BD lotion 0.05% group discontinued the study. Among subjects with at least one TEAE in all groups, the majority had a maximum severity of mild. No severe TEAEs were reported in the vehicle spray or vehicle lotion groups. Severe TEAEs (application site pain and application site pruritus) occurred in two subjects (1.2%) in the BD spray 0.05% group and in two subjects (1.2%) in the augmented BD lotion 0.05% (1 with hyponatremia and alcohol withdrawal syndrome and 1 with chronic obstructive pulmonary disease). There were no clinically meaningful changes in vital sign parameters. Adrenal suppression. In total, 75 subjects were randomized: 23 subjects into 15-day treatment with augmented BD lotion 0.05%, 25 subjects to 15-day treatment with BD spray 0.05%, and 27 subjects to 29-day treatment with BD spray 0.05%. Demographic and baseline characteristics are shown in Table 5. The percentage of subjects who completed the study was similar across the treatment groups (91.3–96.0%). Reasons for discontinuation included subject decision not related to AE (n = 3, one from each treatment group), lost to follow-up (n =1, augmented BD lotion 0.05%), and other (n =1, BD spray 0.05%). All randomized subjects received at least one confirmed dose of study treatment. The subject lost to follow-up in the augmented BD lotion 0.05% group was excluded from all analyses due to the lack of post-baseline data. A total of 22.7 percent (5/22) of subjects in the BD spray 0.05% 15-day group and 20.0 percent of those in the augmented BD lotion 0.05% 15-day group had abnormal ACTH stimulation test results at the end of treatment that were suggestive of adrenal suppression. No subjects in the BD spray 0.05% 29-day group had abnormal ACTH stimulation test results that were suggestive of adrenal suppression (Table 6). Based on the IGA scores, there was marked improvement in the severity of psoriasis in all three treatment groups (Table 7). By Day 15, the proportion of subjects with almost-clear disease was similar in the BD spray 0.05% and augmented BD lotion 0.05% groups (25% vs. 23.8%, respectively). Notably, 12.5-percent of subjects who were treated with BD spray 0.05% had complete clearance of lesions at Day 15 compared to no subjects treated with augmented BD lotion 0.05%. The overall proportion of subjects with IGA success was 32 percent, 37.5 percent, and 23.8 percent in the BD spray 0.05% (29-day group), BD spray 0.05% (15-day group), and augmented BD lotion 0.05% (15-day group), respectively. (Since treatment with augmented BD lotion 0.05% was not continued beyond Day 14, there were no data to report for the 29-day endpoint.) Exposure results are summarized in Table 8. The median number of applications in the 15- day groups was 28 for both BD spray 0.05% and augmented BD lotion 0.05%, while it was 56 FIGURE 1. Percentage of subjects with treatment success a in the efficacy and safety study (n=394)— a IGA of 0 or 1 with at least a 2-grade reduction; b only administered through Day 14 per approved labeling FIGURE 2. Percentage of subjects with ≥50% reduction in TSS in the efficacy and safety study (n = 394)— a Only administered through Day 14 per approved labeling

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