Once-Daily Halobetasol Propionate 0.01% Lotion for Moderate-to-Severe Plaque Psoriasis: Phase 3 Analysis of Hispanic Participants
| Autor: | Seemal R. Desai, Brad Glick, Susan Harris, James Q Del Rosso, Abby Jacobson |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
Male Moderate to severe medicine.medical_specialty Administration Cutaneous Dermatitis Contact Severity of Illness Index Drug Administration Schedule Double-Blind Method Internal medicine Psoriasis Humans Vasoconstrictor Agents Medicine Adverse effect Plaque psoriasis Body surface area Clobetasol Halobetasol Propionate business.industry Hispanic or Latino General Medicine Middle Aged medicine.disease Treatment Outcome Tolerability Lotion Female Dermatologic Agents business |
| Zdroj: | Journal of Drugs in Dermatology. 20:252-258 |
| ISSN: | 1545-9616 |
| DOI: | 10.36849/jdd.5698 |
| Popis: | Background Psoriasis is a chronic, inflammatory disease that may differ in prevalence and clinical presentation among patients from various racial and ethnic groups. Two phase 3 studies demonstrated efficacy and safety of halobetasol propionate (HP) 0.01% lotion in the treatment of moderate-to-severe plaque psoriasis (NCT02514577, NCT02515097). These post hoc analyses evaluated HP 0.01% lotion in Hispanic participants. Methods Participants were randomized (2:1) to receive once-daily HP or vehicle lotion for 8 weeks, with a 4-week posttreatment follow-up. Post hoc efficacy assessments in Hispanic participants (HP, n=76; vehicle, n=43) included treatment success (g2‑grade improvement in Investigatorrs Global Assessment and score of lclearr or lalmost clearr), psoriasis signs, and affected body surface area (BSA). Treatment-emergent adverse events (TEAEs) were evaluated. Results At week 8, 38.8% of participants achieved treatment success with HP versus 10.3% on vehicle (P=0.001). HP‑treated participants achieved greater improvements in psoriasis signs, compared with vehicle (Pl0.01 all). HP group had a greater reduction in affected BSA versus vehicle (P=0.001). Treatment-related TEAEs with HP were application site infection and dermatitis (n=1 each). Conclusions Once-daily HP 0.01% lotion was associated with significant reductions in disease severity in Hispanic participants with moderate-to-severe psoriasis, with good tolerability and safety over 8 weeks. J Drugs Dermatol. 2021;20(3):252-258. doi:10.36849/JDD.2021.5698. |
| Databáze: | OpenAIRE |
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