Journal of Clinical and Aesthetic Dermatology

APR 2018

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

Issue link: https://jcadonline.epubxp.com/i/959274

Contents of this Issue

Navigation

Page 16 of 61

17 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 rates of success for all study treatments at Days 4, 8, 15, and 29. BD spray 0.05% significantly outperformed vehicle spray in the percentage of subjects with a reduction of at least 50 percent in the TSS at Day 4 (12.1% vs. 2.3%, P = 0.004), as shown in Figure 2. At Days 8, 15, and 29, more subjects treated with BD spray 0.05% had reductions of at least 50 percent in the TSS than did subjects in the other treatment groups, but the differences between treatments were not significant. Safety results over the course of the study are summarized in Table 4. There were no deaths reported in any treatment group. The overall incidence of treatment-emergent AEs (TEAEs) was similar among subjects randomized to BD spray 0.05% and vehicle spray and it was higher among subjects who received augmented BD lotion 0.05% and vehicle lotion. Among subjects treated with BD spray 0.05%, there were no serious TEAEs and no subjects discontinued the study. In the vehicle spray group, one subject (1.1%) reported a TABLE 3. Demographics and baseline characteristics in the efficacy and safety study (n=394) DEMOGRAPHICS BD SPRAY, 0.05% (n=174) VEHICLE SPRAY (n = 87) AUGMENTED BD LOTION 0.05% (n = 90) VEHICLE LOTION (n = 43) AGE, YEARS Mean (SD) 49.0 (14.54) 50.2 (14.12) 51.0 (12.75) 51.6 (12.67) Median (range) 49.0 (18–86) 52.0 (20–82) 51.0 (18–78) 52.0 (26–81) SEX, n (%) Male 111 (63.8) 51 (58.6) 56 (62.2) 24 (55.8) Female 63 (36.2) 36 (41.4) 34 (37.8) 19 (44.2) ETHNICITY, n (%) Hispanic/Latino 49 (28.2) 28 (32.2) 25 (27.8) 8 (18.6) Not Hispanic/Latino 125 (71.8) 59 (67.8) 63 (70.0) 35 (81.4) Unknown 0 (0) 0 (0) 2 (2.2) 0 (0) RACE, n (%) American Indian or Alaska Native 0 (0) 2 (2.3) 0 (0) 0 (0) Asian 10 (5.7) 5 (5.7) 4 (4.4) 1 (2.3) African-American 14 (8.0) 3 (3.4) 8 (8.9) 3 (7.0) Native Hawaiian or Other Pacific Islander 1 (0.6) 0 (0) 0 (0) 0 (0) White 146 (83.9) 76 (87.4) 77 (85.6) 38 (88.4) Other 1 (0.6) 1 (1.1) 0 (0) 1 (2.3) Multiple 2 (1.1) 0 (0) 1 (1.1) 0 (0) BSA AFFECTED, % Mean (SD) 13.1 (3.20) 13.1 (3.45) 13.6 (3.39) 12.9 (3.23) Median (range) 12.0 (10–20) 12.0 (10–20) 13.0 (10–20) 12.0 (10–20) IGA, n (%) Moderate 174 (100.0) 87 (100.0) 90 (100.0) 43 (100.0) Severe/very severe 0 (0) 0 (0) 0 (0) 0 (0) LOCATION OF TARGET LESION, n (%) Elbow 47 (27.0) 21 (24.1) 20 (22.2) 9 (20.9) Knee 18 (10.3) 13 (14.9) 12 (13.3) 10 (23.3) Trunk 37 (21.3) 19 (21.8) 16 (17.8) 8 (18.6) Extremities 63 (36.2) 30 (34.5) 39 (43.3) 13 (30.2) Other 9 (5.2) 4 (4.6) 3 (3.3) 3 (7.0) TOTAL SIGN SCORE (0–9) Mean (SD) 6.2 (0.75) 6.3 (0.71) 6.3 (0.80) 6.2 (0.80) Median (range) 6.0 (4–9) 6.0 (5–9) 6.0 (5–9) 6.0 (4–9) n: number; BD: betamethasone dipropionate; SD: standard deviation; BSA: body surface area; IGA: investigators global assessment

Articles in this issue

Archives of this issue

view archives of Journal of Clinical and Aesthetic Dermatology - APR 2018