A recent study showed a novel formulation of tazarotene 0.045% lotion was effective and well-tolerated among patients with moderate to severe acne.
“Tazarotene has been extensively studied in clinical trials and is widely used to treat acne vulgaris (acne), with data suggesting that is one of the most potent topical retinoids,” the researchers said. However, “irritation from the cream, foam, and gel formulations has limited its use in clinical practice.” They assessed the efficacy, safety, and tolerability of a unique tazarotene 0.045% lotion formulation based on polymeric emulsion technology among 1614 participants with moderate to severe acne.
In 2 identical, double-blind, randomized trials, participants were assigned to either tazarotene lotion or vehicle for 12 weeks. Treatment success was defined as at least a 2-grade improvement in Evaluator Global Severity Scores (EGSS) and “clear” or “almost clear” skin, as well as reductions in inflammatory and noninflammatory lesion counts. In addition, the researchers assessed participants’ responses to the validated Acne-Specific Quality of Life (Acne-QoL) questionnaire, adverse events, safety, and cutaneous tolerability.
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The researchers found tazarotene 0.045% lotion demonstrated statistically significant superiority in reducing inflammatory and noninflammatory lesions counts compared with vehicle at week 12. In study 1, the mean percent reductions in inflammatory and noninflammatory lesions counts at week 12 among participants treated with tazarotene lotion were 55.5% and 51.4%, respectively, compared with 45.7% and 41.5% among participants who received vehicle. In study 2, the mean percent reductions in inflammatory and noninflammatory lesions were 59.5% and 60%, respectively, at week 12 in the tazarotene lotion group compared with 49% and 41.6% in the vehicle group.
Overall, 25.5% of participants in study 1 and 29.6% of participants in study 2 achieved treatment success with tazarotene lotion compared with 13% and 17.3% in the vehicle groups, respectively, the researchers said. In addition, they found that improvements in quality of life domain scores had been consistently greater among those treated with tazarotene compared with vehicle.
Tazarotene was well-tolerated, with application site pain (5.3%), dryness (3.6%), and exfoliation (2.1%) being the most commonly reported treatment-related adverse events, the researchers added.
“Tazarotene 0.045% lotion provides statistically significant greater efficacy than vehicle in terms of lesion reduction and treatment success, with a highly favorable safety and tolerability profile in moderate to severe acne patients,” the researchers concluded.
Tanghetti EM, Werschler WP, Lain T, Guenin E, Martin G, Pillai R. Tazarotene 0.045% lotion for once-daily treatment of moderate-to-severe acne vulgaris: Results from two phase 3 trials. J Drugs Dermatol. 2020;19(1): doi:10.36849/JDD.2020.3977