TY - JOUR
T1 - Safety and efficacy of a once-daily halobetasol propionate 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis
T2 - Results of two phase 3 randomized controlled trials
AU - Green, Lawrence J.
AU - Kerdel, Francisco A.
AU - Cook-Bolden, Fran E.
AU - Bagel, Jerry
AU - Lin, Tina
AU - Martin, Gina
AU - Pillai, Radhakrishnan
AU - Israel, Robert
AU - Ramakrishna, Tage
N1 - Publisher Copyright:
© 2018 Journal of Drugs in Dermatology. All rights reserved.
PY - 2018/10
Y1 - 2018/10
N2 - Background: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks. Objective: Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis. Methods: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and ‘clear’ or ‘almost clear’) at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout. Results: Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P<0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs >1%. Limitations: Study did not include subjects with BSA greater than 12. Conclusions: Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course.
AB - Background: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment; long-term safety concerns limiting consecutive use of potent TCS to 2-4 weeks. Objective: Investigate safety and efficacy of halobetasol propionate 0.01% lotion in moderate-to-severe plaque psoriasis. Methods: Two multicenter, randomized, double-blind, vehicle-controlled phase 3 studies (N=430). Subjects randomized (2:1) to halobetasol propionate 0.01% lotion or vehicle once-daily for 8 weeks, 4-week posttreatment follow-up. Primary efficacy assessment: treatment success (at least a 2-grade improvement from baseline in Investigator Global Assessment [IGA] score and ‘clear’ or ‘almost clear’) at week 8. Safety and treatment emergent adverse events (AEs) evaluated throughout. Results: Halobetasol propionate 0.01% lotion demonstrated statistically significant superiority over vehicle as early as week 2. By week 8, 36.5% (Study 1) and 38.4% (Study 2) of subjects were treatment successes compared with 8.1% and 12.0% on vehicle (P<0.001). Halobetasol propionate 0.01% lotion was also superior in reducing psoriasis signs and symptoms, body surface area (BSA), and improving quality of life. Halobetasol propionate 0.01% lotion was well-tolerated with no treatment-related AEs >1%. Limitations: Study did not include subjects with BSA greater than 12. Conclusions: Halobetasol propionate 0.01% lotion was associated with significant reductions in the severity of the clinical signs of psoriasis, without the safety concerns of a longer treatment course.
UR - http://www.scopus.com/inward/record.url?scp=85055614719&partnerID=8YFLogxK
M3 - Article
C2 - 30365586
AN - SCOPUS:85055614719
SN - 1545-9616
VL - 17
SP - 1062
EP - 1069
JO - Journal of Drugs in Dermatology
JF - Journal of Drugs in Dermatology
IS - 10
ER -