Halobetasol Propionate Lotion 0.01% for Moderate-to-Severe Plaque Psoriasis: Pooled Analysis in Male and Female Participants
August 2020 | Volume 19 | Issue 8 | Original Article | 747 | Copyright © August 2020
Published online July 30, 2020
Fran E. Cook-Bolden MDa, Adelaide A. Hebert MDb, Scott T. Guenthner MDc, Robert Kang MSd, Gina Martin MOTe, Abby Jacobson MS PA-Cf
aFran E. Cook-Bolden, MD, PLLC and Department of Dermatology, Mount Sinai Hospital Center, New York, NY bUTHealth McGovern Medical School, Houston, TX cThe Indiana Clinical Trials Center, PC, Plainfield, IN dBausch Health US, LLC*, Bridgewater, NJ eBausch Health US, LLC*, Petaluma, CA fOrtho Dermatologics*, Bridgewater, NJ *Bausch Health US, LLC is an affiliate of Bausch Health Companies Inc. Ortho Dermatologics is a division of Bausch Health US, LLC.
Methods: Participants were randomized (2:1) to once-daily HP or vehicle lotion for 8-weeks of double-blind treatment, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in male (n=253) and female (n=177) subgroups included treatment success (≥2‑grade improvement in Investigator’s Global Assessment [IGA] score and score of ‘clear’ or ‘almost clear’), treatment success in psoriasis signs (erythema, plaque elevation, and scaling) at the target lesion, and change in affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated.
Results: At week 8, rates of IGA-rated treatment success were significantly greater for HP versus vehicle in males (34.0% vs 6.4%) and females (42.7% vs 14.6%; P<0.001 both). Treatment success in each psoriasis sign approached or exceeded 50% for HP-treated males and females, with all differences versus vehicle statistically significant (P<0.001). Percent reduction in affected BSA was significantly greater for HP versus vehicle in males (34.9% vs 6.7%) and females (35.6% vs 4.6%; P<0.001 both). Five HP treatment-related TEAEs (all application site-related) were reported through week 8.
Conclusions: HP lotion was associated with significant reductions in disease severity in male and female participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks of once-daily use. In the overall pooled population, results were similar.
J Drugs Dermatol. 2020;19(8): doi:10.36849/JDD.2020.5250