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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21 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 Results from the adrenal suppression study demonstrate that the potential for HPA-axis suppression with BD spray 0.05% was no greater than with a 14-day regimen of augmented BD lotion 0.05%—even when the spray was used for 28 days. This study also showed that plasma concentrations of BD from BD spray 0.05% were lower than from augmented BD lotion 0.05%, which indicates less systemic absorption. These results were observed despite greater amounts of product used, both in the final application and overall, in the BD spray 0.05% 29-day group than in the augmented BD lotion 0.05% group. Although subjects with abnormal ACTH stimulation test results generally had higher plasma concentrations of betamethasone-17- dipropionate and betamethasone than did subjects with normal results, some subjects with normal post-baseline ACTH stimulation test results had plasma concentrations of betamethasone-17-dipropionate and/or betamethasone as high as some subjects who had abnormal post-baseline ACTH stimulation test results. The results of the visual assessments and chroma meter measurements in the potency studies indicate that BD spray 0.05% should be classified as a midpotent corticosteroid, based on the Stoughton McKenzie testing methodology 10 and REGWQ grouping analyses. Limitations. Despite many strengths, these studies have some limitations. A larger population in the efficacy and safety study and the HPA-axis suppression study might have allowed for a more meaningful comparison between the groups treated with BD spray 0.05% and augmented BD lotion 0.05%. This TABLE 6. Treatment-emergent adverse events in the adrenal suppression study (n= 74 a ) ADVERSE EVENT AUGMENTED BD LOTION 0.05% BD SPRAY, 0.05% 15 DAYS (n=22) 15 DAYS (n=25) 29 DAYS (n=27) HPA-axis suppression 5 (22.7) 5 (20.0) 0 (0.0) Vomiting 0 (0.0) 1 (4.0) 0 (0.0) Application site pain 0 (0.0) 0 (0.0) 1 (3.7) Application site pruritus 1 (4.5) 1 (4.0) 2 (7.4) Chest pain 0 (0.0) 0 (0.0) 1 (3.7) Gingival infection 0 (0.0) 0 (0.0) 1 (3.7) Nasopharyngitis 0 (0.0) 0 (0.0) 1 (3.7) Muscle strain 0 (0.0) 1 (4.0) 0 (0.0) Back pain 0 (0.0) 0 (0.0) 1 (3.7) Headache 0 (0.0) 2 (8.0) 0 (0.0) Acne 0 (0.0) 0 (0.0) 1 (3.7) n: number; BD: betamethasone dipropionate; HPA: hypothalamic–pituitary–adrenal 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. TABLE 7. IGA of efficacy in the adrenal suppression study (n=74 a ) EFFICAC Y BASELINE DAY 8 DAY 15 DAY 29 AUGMENTED BD LOTION 0.05% (n=22) None 0 (0.0) 0 (0.0) 0 (0.0) NA Minimal or almost clear 0 (0.0) 0 (0.0) 5 (23.8) NA Mild 0 (0.0) 6 (27.3) 8 (38.1) NA Moderate 21 (95.5) 16 (72.7) 8 (38.1) NA Severe/very severe 1 (4.5) 0 (0.0) 0 (0.0) NA BD SPRAY, 0.05% 15 DAYS (n=25) None 0 (0.0) 0 (0.0) 3 (12.5) NA Minimal or almost clear 0 (0.0) 2 (8.3) 6 (25.0) NA Mild 0 (0.0) 7 (29.2) 3 (12.5) NA Moderate 22 (88.0) 14 (58.3) 11 (45.8) NA Severe/very severe 3 (12.0) 1 (4.2) 1 (4.2) NA BD SPRAY, 0.05% 29 DAYS (n=27) None 0 (0.0) 0 (0.0) 0 (0.0) 1 (4.0) Minimal or almost clear 0 (0.0) 1 (3.7) 5 (19.2) 7 (28.0) Mild 0 (0.0) 9 (33.3) 7 (26.9) 9 (36.0) Moderate 20 (74.1) 14 (51.9) 13 (50.0) 7 (28.0) Severe/very severe 7 (25.9) 3 (11.1) 1 (3.8) 1 (4.0) n: number; BD: betamethasone dipropionate; HPA: hypothalamic–pituitary–adrenal 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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