Halobetasol Propionate, Tazarotene Lotion Demonstrates Clinically Significant Skin Clearance in Hyperkeratotic Psoriasis

Linda Stein Gold, MD

Credit: Dermatology Research and Education Foundation

Combination treatment with halobetasol propionate and tazarotene lotion was linked to clinically meaningful, early, and sustained skin clearance in patients with hyperkeratotic psoriasis—defined as difficult to treat moderate to severe scaling or plaque elevation—according to data presented at the SDPA Annual Summer Dermatology Conference.¹

“Hyperkeratotic psoriasis producesplaques with extensive elevation andscaling and may be challenging to treat,” wrote a team of investigators led by Linda F Stein Gold, MD, vice president for the American Academy of Dermatology and the director of Dermatology Clinical Research at Henry Ford Health.¹ “Tazarotene-induced gene modulationand the antiproliferative effect ofcorticosteroids (eg, halobetasolpropionate) may normalize thekeratinocyte differentiation andproliferation observed in psoriasis. Therefore, halobetasolpropionate/tazarotene (indicated for topicaltreatment of plaque psoriasis in adults)may be an effective topical treatment forhyperkeratotic plaques.”

The lotion, which was first approved by the US Food and Drug Administration (FDA) in 2019, was the first topical treatment for plaque psoriasis to combine halobetasol propionate and tazarotene. The inclusion of tazarotene, a retinoid product, in the lotion provides a different mechanism of action for treating psoriasis.²

“Duobrii provides the known benefits of a potent topical corticosteroid and a topical retinoid with synergistic efficacy. Combination therapy is the mainstay of topical treatment for plaque psoriasis, making Duobrii an important new option,” noted Stein Gold regarding the FDA approval.²

The post hoc analysis of 2 phase 3 trials of halobetasol propionate (.01%) and tazarotene (.045%) lotion assessed skin clearance as determined by the product of the investigator’s global assessment (IGA) and the affected body surface area (BSA) among patients with moderate to severe scaling or plaque elevation. Moderate to severe scaling or plaque elevation was defined as a baseline target plaque score of 3 (moderate) or 4 (severe). The IGA×BSA measure determines psoriasis severity, with a ≥ 75% improvement from baseline (IGA×BSA-75) linked to a ≥ 75% improvement in psoriasis area and severity index.¹

Patients enrolled in the phase 3 trials were randomized to receive either once-daily HP/tazarotene or vehicle lotion. Subjects were then evaluated at weeks 2 through 8, in addition to a posttreatment follow-up at week 12. Primary endpoints included the rates of patients obtaining IGA×BSA-75 or IGA×BSA-90 and the mean change from baseline in IGA×BSA.¹

Significantly greater rates of IGA×BSA-75 were reported at week 2, which were sustained through week 12, in patients receiving halobetasol propionate/tazarotene lotion compared with the vehicle cohort. At week 12, 42.2% of patients with moderate to severe scaling achieved IGA×BSA-75 compared with only 9.5% of those in the control group. Similarly, 41.7% of those with moderate to severe plaque elevation receiving combination treatment were able to achieve 75% improvement compared with 9.2% of controls. Further, treatment with halobetasol propionate/tazarotene was linked to significantly greater rates of IGA×BSA-90.¹

Regarding mean IGA×BSA changes from baseline, patients with moderate to severe scaling in the halobetasol propionate/tazarotene cohort exhibited a -24.7% change at week 2, which further decreased to a -46.3% change at week 12, compared with a -5.1% change at week 2 and -10.8% at week 12 in the vehicle cohort. Those with moderate to severe plaque elevation treated with the combination therapy reported similar results at weeks 2 and 12 (-25.7% and -46.4%, respectively), which was significantly higher than the vehicle group (-4.3% and -7.5%, respectively).¹

References

1. ^{Stein Gold L, Tangetti E, Lain E, Murina A, Jacobson A. Early and Sustained Efficacy of Fixed- Combination Halobetasol Propionate and Tazarotene Lotion in Participants With Moderate-to-Severe Scaling or Plaque Elevation. Presented at: SDPA Annual Summer Dermatology Conference. San Diego, CA. June 5 – 9, 2024.}
2. ^{Gingerich CP. FDA approves combination lotion for plaque psoriasis. HCP Live. April 25, 2019. Accessed June 12, 2024. https://www.hcplive.com/view/fda-approves-combination-lotion-plaque-psoriasis.}