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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22 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 limitation, while noteworthy, does not appear to have influenced the results, however. CONCLUSION In subjects with moderate plaque psoriasis, BD spray 0.05% was significantly more effective than vehicle spray, as measured by the proportion of subjects with treatment success (IGA = 0 or 1 and at least a 2-grade reduction from baseline) after 14 and 28 days of twice- daily treatment, and by a 50-percent or greater reduction in TSS at Days 4, 15, and 29. The spray formulation also yielded an earlier and more pronounced response to treatment than did high-potent augmented BD lotion 0.05% and a vehicle lotion. 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. With treatment lasting up to 29 days, the potential for adrenal suppression was no greater with BD spray 0.05% than with a 15-day regimen of augmented BD lotion 0.05%. There was less systemic absorption of BD spray 0.05% than of augmented BD lotion 0.05%, as shown by lower median plasma concentrations. Based on visual assessment and chroma meter results from two studies, BD spray 0.05% should be classified as a midpotent corticosteroid. REFERENCES 1. Rachakonda TD, Schupp CW, Armstrong AW. Psoriasis prevalence among adults in the United States. J Am Acad Dermatol. 2014;70(3):512–516. 2. National Psoriasis Foundation. About psoriasis. Available at: https://www.psoriasis.org/sites/ default/files/psoriasis_fact_sheet.pdf. Accessed July 12, 2017. 3. Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 3. Guidelines of care for the management and treatment of psoriasis with topical therapies. J Am Acad Dermatol. 2009;60(4):643–659. 4. Mason AR, Mason J, Cork M, et al. Topical treatments for chronic plaque psoriasis. Cochrane Database Syst Rev. 2013;(3):CD005028. 5. Nordwall C. Local treatment of psoriasis and eczema with betamethasone-17,21-dipropionate (Diproderm cream): a double-blind comparsion with fluocortolone caproate, fluocortolone pivalate (Ultralanum cream). Curr Ther Res Clin Exp. 1974;16(8):798–803. 6. SERNIVO Spray (betamethasone dipropionate) prescribing information. Available at: http://sernivo. com/documents/sernivo-pi.pdf. Accessed July 12, 2017. 7. Kircik L, Okumu F, Kandavilli S, Sugarman J. Rational vehicle design ensures targeted cutaneous steroid delivery. J Clin Aesthet Dermatol. 2017;10(2):12–19. 8. Stein Gold L, Jackson JM, Knuckles ML, Weiss JS. Improvement in extensive moderate plaque psoriasis with a novel emollient spray formulation of betamethasone dipropionate 0.05. J Drugs Dermatol. 2016;15(3):334–342. 9. Fowler JF Jr, Hebert AA, Sugarman J. DFD-01, a novel medium potency betamethasone dipropionate 0.05% emollient spray, demonstrates similar efficacy to augmented betamethasone dipropionate 0.05% lotion for the treatment of moderate plaque psoriasis. J Drugs Dermatol. 2016;15(2):154–162. 10. Cornell RC, Stoughton RB. Correlation of the vasoconstriction assay and clinical activity in psoriasis. Arch Dermatol. 1985;121(1):63–67. JCAD TABLE 9. Potency of BD spray 0.05% from Studies 1 and 2 (n=118) STUDY 1 VCA, MEAN BD SPRAY, 0.05% AUGMENTED BD 0.05% MOMETASONE FUROATE 0.1% OINTMENT USP FLUTICASONE PROPIONATE 0.05% CREAM HYDROCORTISONE 2.5% CREAM OINTMENT LOTION CREAM Visual 1.14 2.40 1.98 2.30 2.50 1.19 0.83 Chroma meter 0.46 1.17 1.06 0.72 0.94 0.38 -0.05 STUDY 2 VCA, MEAN (SD) BD SPRAY, 0.05% AUGMENTED BD 0.05% TRIAMCINOLONE ACETONIDE 0.1% CREAM USP FLUTICASONE PROPIONATE 0.05% CREAM HYDROCORTISONE 2.5% CREAM OINTMENT LOTION CREAM Visual 1.30 ( 0.71) 2.51 ( 0.50) 2.06 (0.74) 2.07 ( 0.76) 1.15 (0.75) 1.26 (0.86) 0.63 (0.56) Chroma meter 0.86 (0.70) 2.04 (0.81) 1.72 (0.80) 1.60 (0.87) 0.59 (0.76) 0.54 (0.82) 0.06 (0.00) n: number; BD: betamethasone dipropionate; VCA: vasoconstrictor assay; SD: standard deviation TABLE 8. Exposure at Days 15 and 29 in the adrenal suppression study (n=74 a ) EXPOSURE AUGMENTED BD LOTION 0.05% BD SPRAY, 0.05% 15 DAYS (n =22) 15 DAYS (n=25) 29 DAYS (n=27) APPLICATIONS, n Mean (SD) 28.8 (3.59) 29.6 (2.64) 56.2 (5.39) Median (range) 29.0 (17-33) 29.0 (23-34) 57.0 (39-69) DRUG USED, FINAL APPLICATION (G) Mean (SD) 4.02 (1.94) 6.82 (3.96) 7.08 (4.49) Median (range) 3.90 (1.5-7.1) 5.05 (2.8-17.0) 5.85 (0.6-19.2) TOTAL DRUG USED (G) Mean (SD) 102.63 (40.358) 129.66 (58.570) 238.22 (155.522) Median (range) 98.30 (44.2-212.6) 132.15 (30.4-230.2) 178.55 (87.8-805.3) n: number; BD; betamethasone dipropionate; SD; standard deviation 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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