Arazlo™ (tazarotene; Bausch Health Companies) Lotion 0.045% is now available for the topical treatment of acne vulgaris in patients aged ≥9 years.

The approval was based on data from 2 multicenter, randomized, double-blind, vehicle-controlled phase 3 trials that evaluated Arazlo in 1614 patients with moderate to severe acne. Results from both studies showed that treatment with Arazlo led to statistically significant improvements in inflammatory and noninflammatory lesion counts at week 12, along with success on the Evaluator Global Severity Score (EGSS), defined as a ≥2 grade improvement from baseline and an EGSS score of “clear” or “almost clear” skin (P <.001).

Additionally, a head-to-head phase 2 trial comparing Arazlo to Tazorac (tazarotene) cream 0.1% showed similar treatment success rates and reductions in inflammatory and noninflammatory lesions over 12 weeks and fewer adverse events with Arazlo (2.9% vs 5.6%, respectively).

“Clinical studies have demonstrated that Arazlo’s proprietary formulation provides the proven efficacy of a retinoid in a lotion that is more tolerable to patients than a higher concentration tazarotene,” said Bill Humphries, president, Ortho Dermatologics.

Each gram of Arazlo contains 0.45mg of tazarotene, a retinoid prodrug. The topical treatment is applied once daily to the affected areas. Concomitant use with oxidizing agents, such as benzoyl peroxide, should be avoided, however, if it is necessary, the treatments may be applied at different times of the day.

With regard to safety, the most common adverse events reported with treatment include application site pain, dryness, exfoliation, erythema and pruritus. Arazlo is contraindicated in pregnancy as it may cause fetal harm based on retinoid pharmacology.

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To assist eligible patients, the Company is offering a copay savings card for Arazlo. 

The product is supplied in 45g tubes.

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