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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20 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 respectively, and REGWQ groupings of C,D based on visual assessment and C based on chroma meter data. Using visual data, the potency of BD spray 0.05% fell between that of fluticasone propionate 0.05% cream (midpotent) and hydrocortisone cream USP 2.5% (low-potent). Using the chroma meter findings, the potency of BD spray 0.05% was determined to be between that of augmented BD 0.05% cream (high-potent) and fluticasone propionate 0.05% cream (midpotent). No AEs were reported in this study. Of 80 subjects enrolled in the pivotal potency study, 78 (97.5%) completed the study. Two subjects (2.5%) did not return to the clinic on Day 2 and were considered to have voluntarily withdrawn. BD spray 0.05% had mean (SD) visual and chroma meter assessment scores of 1.29 (0.71) and 0.86 (0.70), respectively, and a REGWQ grouping of C for both assessments. The visual assessment indicated that the potency of BD spray 0.05% was between that of augmented BD lotion 0.05% (high potent) and fluticasone propionate 0.05% cream (midpotent) and the chroma meter assessment showed that the potency of BD spray 0.05% fell between that of augmented BD cream 0.05% (high potent) and triamcinolone acetonide USP cream 0.1% (upper-midpotent), as shown in Table 9. Two AEs, rash macular and pruritus, were reported by a single subject; both events were considered mild and had resolved. DISCUSSION These studies were designed to evaluate the efficacy and safety, potential for adrenal suppression and systemic absorption, and potency of BD spray 0.05%. In the efficacy and safety study, adults with moderate plaque psoriasis treated their condition twice daily for 28 days and BD spray 0.05% was found to be significantly more effective than vehicle spray. The spray formulation also achieved a faster and more pronounced response to treatment than did high-potency augmented BD lotion 0.05% and a vehicle lotion. At the same time, the safety of BD spray 0.05% was similar to that of a vehicle spray over 28 days and to augmented BD lotion 0.05% over 14 days. These findings provide evidence that the novel vehicle technology in BD spray 0.05% allows this midpotent steroid to act more like a high-potent steroid. This suggests that, in clinical practice, BD spray 0.05% might benefit patients with psoriasis as a monotherapy as well as a treatment for resistant plaques in patients receiving systemic therapy. TABLE 5. Demographics and baseline characteristics in adrenal suppression study (n=74 a ) DEMOGRAPHICS AUGMENTED BD LOTION 0.05% BD SPRAY, 0.05% 15 DAYS (n=22) 15 DAYS (n=25) 29 DAYS (n=27) AGE, YEARS Mean (SD) 45.4 (11.32) 47.6 (13.71) 46.8 (9.99) Median (range) 47.5 (20–59) 52.0 (20–72) 48.0 (26–68) SEX, n (%) Male 16 (72.7) 16 (64.0) 21 (77.8) Female 6 (27.3) 9 (36.0) 6 (22.2) ETHNICITY, n (%) Hispanic/Latino 15 (68.2) 12 (48.0) 17 (63.0) Not Hispanic/Latino 7 (31.8) 13 (52.0) 10 (37.0) RACE, n (%) Asian 1 (4.5) 2 (8.0) 1 (3.7) African-American 1 (4.5) 3 (12.0) 2 (7.4) White 20 (90.9) 20 (80.0) 24 (88.9) BSA AFFECTED, % Mean (SD) 26.8 (6.32) 29.0 (11.04) 26.5 (8.61) Median (range) 25.5 (20–40) 24.0 (20–50) 22.0 (20–50) IGA, n (%) Moderate 21 (95.5) 22 (88.0) 20 (74.1) Severe/very severe 1 (4.5) 3 (12.0) 7 (25.9) ACTH STIMULATION TEST, n (%) Normal 22 (100.0) 25 (100.0) 27 (100.0) Abnormal 0 (0) 0 (0) 0 (0) n: number; BD; betamethasone dipropionate; HPA; hypothalamic–pituitary–adrenal; SD; standard deviation; BSA: body surface area; IGA: investigators global assessment; ACTH: adrenocorticotropic hormone a One subject who was lost to follow-up in the BD lotion 0.05% group was excluded from all analyses due to the lack of post-baseline safety (or any other) data.

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