Background: Topical
corticosteroids (TCS) represent a mainstay of
psoriasis treatment, though more potent formulations are not recommended for use for more than 2 to 4 weeks. Objective: We sought to investigate the safety and efficacy of once-daily
halobetasol propionate 0.01%/
tazarotene 0.045% (HP/TAZ) lotion and
halobetasol propionate 0.05% cream in patients with moderate-to-severe plaque
psoriasis. Methods: This was a multicenter, randomized, double-blind, parallel-group, vehicle-controlled Phase II study (n=154). Patients were randomized (2:2:1) to HP 0.01%/TAZ 0.045% lotion,
halobetasol propionate 0.05% cream, or vehicle, applied topically once daily for two weeks. Efficacy assessments included treatment success, impact on individual
psoriasis signs (i.e.,
erythema, plaque elevation, and scaling) at target lesion, and body surface area (BSA). Safety and adverse events (AEs) were evaluated throughout. Results: HP/TAZ lotion was significantly more effective than vehicle and was comparable to
halobetasol propionate 0.05% cream in reducing
erythema, plaque elevation, and scaling. Of the HP/TAZ patients, 32.8 percent achieved treatment success versus 34.0 and 3.3 percent in the
halobetasol and vehicle groups. At Week 2, treatment success was seen in 34.4 percent (
erythema), 54.1 percent (plaque elevation), and 60.7 percent (scaling) of patients versus in 43.5, 50.8, and 50.8 percent receiving
halobetasol. A 25.0- and 24.8-percent reduction in BSA occurred, respectively. The most frequently reported, treatment-related AE was application site
pain. Conclusions: The efficacy of HP/TAZ lotion was comparable to a higher concentration of 0.05%
halobetasol cream, showing rapid treatment success after two weeks with good safety.