Fixed-Combination Halobetasol Propionate 0.01% and Tazarotene 0.045% Lotion and Halobetasol Propionate 0.01% Lotion for Plaque Psoriasis on Areas With Body Hair: Maintenance of Treatment Effect
Authors: Han George , Lain Edward , Stein Gold Linda , Jacobson Abby 
Published: November 2024

Background: Psoriasis on hair-bearing body areas may be difficult to treat with topical therapy, as hair may reduce penetration of active ingredients.1 Patients may also experience disease rebound following cessation of corticosteroid therapy.2,3 An appropriate vehicle for hair-bearing areas may increase penetration, and a combination of corticosteroid and tazarotene may improve maintenance of treatment effect following cessation.4-6 Fixed-combination halobetasol propionate (0.01%) and tazarotene (0.045%) lotion (HP/TAZ) and HP 0.01% lotion are indicated for treatment of plaque psoriasis in adults7,8 and contain a vehicle optimized for penetration.6,9 Previously, a post hoc analysis demonstrated the efficacy and safety of HP/TAZ and HP in treating men with plaque psoriasis on the leg, a representative area with body hair.10 Here, we expand on the previous study by reporting maintenance of efficacy following treatment cessation in this population.
Methods: In phase 3 trials, participants with moderate-to-severe plaque psoriasis were randomized to treatment or vehicle once daily for 8 weeks (HP/TAZ, n=276; vehicle, n=142; HP, n=285; vehicle, n=145). Participants were assessed at 2-week intervals and at 4 weeks after treatment cessation (week 12).11,12 In this post hoc analysis, treatment success (≥2-grade improvement in investigator’s global assessment score and score of clear or almost clear); erythema, plaque elevation, and scaling success (≥2-grade improvement for each); and safety were assessed in men with psoriasis on the leg treated with HP/TAZ (n=87) or HP (n=91). Maintenance of effect was defined as the proportion of participants who achieved treatment, erythema, plaque elevation, or scaling success at week 8 and maintained success at week 12. Men were assumed to have leg hair. Treatment comparisons were indirect.
Results: Four weeks after treatment cessation, HP/TAZ–treated participants exhibited increased rates of treatment success (week 8, 35.3%; week 12, 37.2%) and erythema success (week 8, 37.4%; week 12, 48.4%), whereas HP-treated participants exhibited decreased rates (treatment success: week 8, 35.5%; week 12, 23.1%; erythema success: week 8, 50.6%; week 12, 36.5%). HP/TAZ–treated participants exhibited less attrition in plaque elevation and scaling success after treatment cessation (week 8, 57.4% and 56.3%; week 12, 55.1% and 55.8%, respectively) versus HP-treated participants (week 8, 53.1% and 61.7%; week 12, 39.8% and 41.6%, respectively). For all outcomes, a greater proportion of participants receiving HP/TAZ achieved maintenance of effect from weeks 8 to 12 compared with participants receiving HP (range: HP/TAZ, 74%-85%; HP, 56%-62%). No new safety signals were identified.
Conclusions: Following treatment cessation of HP/TAZ, men with plaque psoriasis on the leg experienced further disease improvement and maintained treatment effects at greater rates than those treated with HP, suggesting that tazarotene combined with HP provides prolonged efficacy in hair-bearing areas.