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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19 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 in the 29-day group receiving BD spray 0.05%. The maximum number of applications for an individual subject was 43 with augmented BD lotion 0.05% and 67 with BD spray 0.05%. The median amount of study drug used for the final application was greater in the BD spray 0.05% 15-day and 29-day groups (5.05g and 5.85g, respectively) than in the augmented BD lotion 0.05% 15-day group (3.9g). The median total amount of drug used was greater in the BD spray 0.05% 15-day group (132.15g) than in the augmented BD lotion 0.05% 15-day group (98.30g); it was greatest in the BD spray 0.05% 29-day group (178.55g). The maximum amount of study medication used was 212.6g with augmented BD lotion 0.05% and 805.3g with BD spray 0.05%. The incidence of TEAEs was similar across the treatment groups, ranging from 25.9 to 32 percent. No deaths, serious TEAEs, or discontinuations due to TEAEs were reported. The most frequently reported TEAE was HPA axis suppression in the 15-day treatment groups, followed by application site pruritus in all groups (Table 6). Application site burning/ stinging was reported for one subject in the BD spray 0.05% 29-day group. The incidence of burning/stinging, pain, and itching decreased from baseline to day 15 in all groups. Two subjects in the BD spray 0.05% 15-day group reported headaches. No clinically significant atrophy or telangiectasia was seen in any subject at any time during the study and no clinically meaningful changes in vital sign parameters were observed. The majority of subjects in all groups had no measurable plasma concentration (< 5.00 pg/ ml) of betamethasone-17,21-dipropionate at almost all time points just before and after the last application of BD spray 0.05%, whereas the metabolites betamethasone-17-propionate and betamethasone were detected in the majority of subjects. Among subjects with measurable concentrations of betamethasone- 17-propionate, the mean concentrations just before the last dose in the augmented BD lotion 0.05% and BD spray 0.05% 15-day groups (100 pg/ml and 117 pg/ml, respectively) were approximately double the concentration seen in the BD spray 0.05% 29-day group (48 pg/ ml). A similar trend was seen for the mean of the average of the one-, three-, and six-hour plasma concentrations and the mean C max . Results were similar for the other metabolite, betamethasone; the mean concentration at baseline (zero hours) was similar to the mean concentrations at one, three, and six hours after the last dose and similar to the mean C max for both metabolites. A comparison of the medians showed that overall metabolite levels were the highest for the augmented BD lotion 0.05% 15-day group. Potency. All 40 subjects enrolled in the pilot potency study completed the study (100%). BD spray 0.05% had mean visual and chroma meter assessment scores of 1.14 and 0.46, TABLE 4. Treatment-emergent adverse events (Days 1–29) in 2% or more of subjects in the efficacy and safety study (n=393) EVENT CHARACTERISTICS BD SPRAY, 0.05% (n = 174) VEHICLE SPRAY (n = 87) AUGMENTED BD LOTION 0.05% (n = 90) VEHICLE LOTION (n = 43) EVENTS REPORTED, n (%) 73 (41.9) 40 (46.0) 51 (56.7) 33 (76.7) ≥ 1 TEAE, n (%) 49 (28.3) 20 (23.0) 28 (31.1) 21 (48.8) ≥ 1 serious TEAE, n (%) 0 (0.0) 1 (1.1) 2 (2.2) 0 (0.0) Median (range) 49.0 (18–86) 52.0 (20–82) 51.0 (18–78) 52.0 (26–81) MAXIMUM SEVERITY Mild 35 (20.2) 10 (11.5) 21 (23.3) 17 (39.5) Moderate 12 (6.9) 10 (11.5) 5 (5.6) 4 (9.3) Severe 2 (1.2) 0 (0.0) 2 (2.2) 0 (0.0) RELATIONSHIP WITH STUDY DRUG, n (%) Not 15 (8.7) 5 (5.7) 12 (13.3) 6 (14.0) Possibly 19 (11.0) 10 (11.5) 9 (10.0) 9 (20.9) Probably 11 (6.4) 3 (3.4) 5 (5.6) 2 (4.7) Definitely 4 (2.3) 2 (2.3) 2 (2.2) 4 (9.3) TEAEs IN ≥ 1% OF SUBJECTS, n (%) Application site atrophy 4 (2.3) 1 (1.1) 0 (0.0) 1 (2.3) Application site pain 18 (10.4) 12 (13.8) 15 (16.7) 10 (23.3) Application site pruritus 15 (8.7) 12 (13.8) 8 (8.9) 14 (32.6) Nasopharyngitis 4 (2.3) 1 (1.1) 0 (0.0) 0 (0.0) Upper respiratory tract infection 5 (2.9) 0 (0.0) 1 (1.1) 1 (2.3) Upper respiratory tract infection 5 (2.9) 0 (0.0) 1 (1.1) 1 (2.3) Arthralgia 0 (0.0) 0 (0.0) 1 (1.1) 1 (2.3) Sinus congestion 0 (0.0) 0 (0.0) 2 (2.2) 0 (0.0) n: number; BD: betamethasone dipropionate; TEAE: treatment-emergent adverse event

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