Safety and efficacy of a fixed combination halobetasol and tazarotene lotion in the treatment of moderate-to-severe plaque ssoriasis: Subgroup analysis

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J Clin Aesthet Dermatol


Background/Objective: Topical corticosteroids (TCS) are the mainstay of psoriasis treatment, but safety concerns might limit use. Combination with tazarotene might optimize efficacy and minimize safety and tolerability concerns. The objective was to investigate safety and efficacy of halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in moderate-to-severe plaque psoriasis. Methods: The study included two multicenter, randomized, double-blind, vehicle-controlled Phase III trials (N=418). Subjects randomized (2:1) to HP/TAZ lotion or vehicle once-daily for four weeks with a four-week follow-up. Primary efficacy assessment was measured based on treatment success (at least a two-grade improvement from baseline in IGA score and 'clear' or 'almost clear'). Safety and treatment-emergent AEs were evaluated throughout. Differences in treatment success and safety were evaluated in a number of subpopulations. Results: HP/TAZ lotion demonstrated statistically significant superiority over vehicle as early as Week 2 (p=0.002). By Week 8, 40.6 percent of subjects were treatment successes compared to 9.9 percent on the vehicle (p<0.001). HP/TAZ lotion appeared more efficacious in subjects who were women, younger, and with moderate psoriasis. By Week 8, 41.6 percent of subjects with moderate disease (compared to 35.0% severe); 44.6 percent of female subjects (compared to 38.4% male); and 43.4 percent of subjects younger than 51 years (compared to 37.9% ≥51 years old) were treatment successes. Ethnicity did not appear to influence efficacy. Treatmentrelated adverse events (AEs) were more common in female subjects (23.2% compared to 18.7%), although they tended to be milder. Conclusion: HP/TAZ lotion provides good efficacy and tolerability overall, with greater efficacy in patients who are younger women with moderate psoriasis.





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