Recent recearch has reported positive results with a new treatment for plaque psoriasis. The research, which was published in the Journal of the American Academy of Dermatology discussed the first positive results from two phase 3, multicenter, randomized, double-blind clinical trials. These trials assessed the safety of an investigational topical treatment lotion that combines halobetasol propionate and tazarotene (DUOBRII) in the treatment of plaque psoriasis.
The Study
There were two studies that were conducted with a total of 418 patients, 18 years or older. These studies worked to determine how effective the DUOBRII lotion was compared to vehicle with an Investigator Global Assessment (IGA) score of three or four and an affected body surface area of 3-12%.
This double-blind, multicenter, randomized vehicle-controlled phase 3 study had patients randomized 2:1 to receive DUOBRII or vehicle once daily for eight weeks. The patients then had a follow-up after four weeks of discontinuation of the active treatment.
The investigator assessed the IGA on a five-point scale that ranged from zero (clear) to four (severe) at each visit. Secondary adequate data was then provided for weeks two, four, six and twelve.
Conclusions
DUOBRII was superior in reducing psoriasis signs and symptoms, and the body surface area affected compared to vehicle. When halobetasol propionate and tazarotene were used separately to treat plaque psoriasis, they were limited to a four-week or less time frame and a high rate of adverse events.
"DUOBRII is a fixed dose combination of halobetasol and tazarotene that has shown synergistic efficacy in the Phase 2 study. Efficacy was again demonstrated in the two phase 3 studies versus vehicle with minimal side effects in a well-tolerated, patient preferred formulation," explained Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System.
