Combination therapy with halobetasol propionate 0.01%/tazarotene 0.045% (HP/TAZ) lotion in patients with moderate to severe plaque psoriasis provides a sustained treatment effect after 8 weeks of therapy and a 4-week posttreatment period, according to the results of a phase 2, multicenter, randomized, double-blind, vehicle-controlled study published in the Journal of Drugs in Dermatology.
A total of 212 participants were enrolled in the study. Patients were randomly assigned in a 2:2:2:1 ratio to 1 of 4 treatments: HP/TAZ lotion, HP lotion, TAZ lotion, or vehicle. All treatments were administered once daily for 8 weeks, with a 4-week posttreatment follow-up.
Efficacy assessments included treatment success (ie, ≥2-grade improvement from baseline in Investigator Global Assessment [IGA] score and ratings of “clear” or “almost clear”), along with effect on the individual signs of psoriasis (ie, erythema, plaque elevation, and scaling) at the target lesion.
By week 8, HP/TAZ lotion demonstrated statistically significant superiority in terms of treatment success (ie, IGA) over HP alone (P =.033), TAZ alone (P <.001), or vehicle (P <.001). At the conclusion of the 4-week posttreatment period, 38.2% of HP/TAZ-treated patients were considered treatment successes compared with 21.0%, 12.8%, and 6.9% of those who had received treatment with HP (P =.042), TAZ (P =.004), or vehicle (P =.002), respectively.
The levels of improvement from baseline mean IGA observed with HP/TAZ lotion at week 8 (47.0%) were maintained 4 weeks posttreatment. Moreover, the level of improvement in mean IGA from baseline to week 12 (40.9%) was higher than that attained with either individual active ingredient (28.5% with HP vs 21.3% with TAZ). Mean IGA score with HP/TAZ lotion at week 12 was 1.8 compared with 2.2, 2.4, and 2.6 with HP, TAZ, and vehicle, respectively.
In addition, HP/TAZ was also superior to the other therapies in the maintenance of reduction in psoriasis-associated signs of erythema, plaque elevation, and scaling at the target lesion.
The investigators concluded that a fixed combination of a mid- to high-potency corticosteroid (ie, halobetasol propionate 0.01%) and low-dose tazarotene (0.045%) is associated with synergistic and sustained efficacy in patients with moderate to severe psoriasis 4 weeks’ posttreatment.
Pariser DM, Green LJ, Stein Gold L, Sugarman JL, Lin T, Pillai R. Halobetasol 0.01%/tazarotene 0.045% lotion in the treatment of moderate-to-severe plaque psoriasis: maintenance of therapeutic effect after cessation of therapy. J Drugs Dermatol. 2018;17(7):723-726.