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FDA Approves Topical Therapy for Psoriasis

The US Food and Drug Administration has approved the topical treatment halobetasol propionate tazarotene 0.01%/0.045% lotion (Duobrii) for the treatment of plaque psoriasis.

In clinical trials, the topical therapy was consistently more effective than vehicle for treating psoriasis. Phase 3 trials showed that 36% and 45% of participants achieved clear or almost clear skin after 8 weeks compared with 7% and 13% of those treated with vehicle, respectively. An open-label study also demonstrated the long-term safety of the topical treatment over a year.
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“Doubrii 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 Doubrii an important new option,” 
said Linda Stein Gold, MD, director of dermatology clinical research at the Henry Ford Health System, in a press release. “Although effective, topical retinoids have had limited use as monotherapy due to tolerability concerns. Doubrii provides improved local tolerability, allowing patients to benefit from an extended duration of use.”

Women of child-bearing age must have a negative pregnancy test prior to initiating treatment and must use effective birth control during treatment, as the lotion may cause birth defects.

The most common adverse effects associated with treatment include redness, itching, swelling, burning, stinging, application site pain, folliculitis, atrophy, peeling, and rash. Other related adverse events include Cushing syndrome, hyperglycemia, and increased risk of developing cataracts and glaucoma.

Reference

Ortho Dermatologics receives FDA approval of Duobrii (halobetasol proprionate and tazarotene lotion 0.01%/0.045% for plaque psoriasis in adults [press release]. Raleigh, NC: Ortho Dermatologics; April 25, 2019. Accessed April 26, 2019.

 

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