Dow Pharmaceutical Sciences, Inc.

Background: Halobetasol propionate (HP) 0.05% is a highly effective short-term treatment for plaque psoriasis. Objective: Compare efficacy and safety of once-daily HP 0.01% lotion and 0.05% cream (Ultravate^®) in moderate-to-severe psoriasis. Methods: Multicenter, randomized, double-blind, vehicle-controlled Phase 2 study (N = 150). Patients randomized to HP 0.01% lotion, HP 0.05% cream, or vehicle, once-daily for 2 weeks. Efficacy assessments included treatment success; impact on erythema, plaque elevation, and scaling; and improvement in body surface area (BSA). Safety and treatment-emergent adverse events (TEAEs) were evaluated throughout. Results: 30.0% and 31.6% of patients were treatment successes with HP 0.01% lotion and HP 0.05% cream (p = .854). A 2-grade improvement in erythema, plaque elevation and scaling was achieved in 38.3%, 40.0%, and 43.3% of patients, compared with 31.6% (p = .446), 36.8% (p = .727), and 47.4% (p = .663) on HP 0.05% cream. BSA improved by 22.3% with HP 0.01% lotion compared with 20.9% (p = .787). There was one treatment-related application-site reaction with HP 0.01% lotion, and no AE reports of skin atrophy, striae, telangiectasia, or folliculitis. Conclusions: Halobetasol propionate 0.01% lotion was comparable to the higher concentration halobetasol propionate 0.05% cream; achieving treatment success, reducing psoriasis signs at the target lesion, and improving BSA following two weeks' daily-treatment. Both treatments were well-tolerated. Clinical Trials Registration: clinicaltrials.gov NCT02785185.

This supplement features scientific abstracts from the Skin Disease Education Foundation's 43rd Annual Hawaii Dermatology Seminar® (February 17-22, 2019).

This study examined a fixed combination halobetasol propionate 0.01% and tazarotene 0.045% lotion to treat moderate-to-severe plaque psoriasis.Study participants were treated with HP/TAZ lotion once daily for 8 wk and then as needed.Participants were treated with HP/TAZ lotion once daily for 4 wk if they had not achieved treatment success or received no treatment until the next evaluation if they had achieved treatment success, with a maximum continuous exposure of 24 wk.AE incidence was similar to that reported in the pivotal studies and peaked around day 60, remaining stable from day 90 until study end, treatment related AEs reported by ≥2% of participants within any designated treatment period included application site reactions of dermatitis, pruritus, and pain.Treatment-emergent seriousAEs (SAEs)were noted in 3.3% of participants; none were considered treatment-related and discontinued due to SAEs (cellulitis gangrenous, pericardial effusion, small intestine adenocarcinoma).Overall, 7.5% of participants discontinued due to treatment-emergent AEs: dermatitis and pruritus (7 persons each) and pain (6 persons) were the most frequent.In summary, we report the long-term safety profile of HP/TAZ lotion in participants with moderateto-severe psoriasis when used as monotherapy over a period of 1 yr.