General Information

Arazlo (tazarotene) is a retinoid.

Arazlo is specifically indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Arazlo is supplied as a cream for topical administration. Apply a thin layer of Arazlo to the affected areas once daily. Avoid the eyes, mouth, paranasal creases, and mucous membranes. If Arazlo gets in or near eyes, rinse thoroughly with water. Wash hands thoroughly after applying Arazlo.

Avoid concomitant use with oxidizing agents, such as benzoyl peroxide. If the concomitant use of Arazlo with oxidizing agents is required, apply each at different times of the day (e.g. one in the morning and the other in the evening).

Use effective sunscreens and wear protective clothing while using Arazlo.

Clinical Trials

FDA Approval

The FDA approval for Arazlo was based on data from two Phase 3 multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. The efficacy endpoints of success on the Evaluator’s Global Severity Score (EGSS), absolute change in noninflammatory lesion count, and absolute change in inflammatory lesion count were assessed at Week 12. Success on the EGSS was defined as at least a 2-grade improvement from Baseline and an EGSS score of clear (0) or almost clear (1). In both Phase 3 studies, all primary efficacy endpoints were met with statistical significance.

In a Phase 2, head-to-head study, Arazlo and Tazorac (tazarotene) Cream 0.1% showed similar treatment success rates and similar reductions in both inflammatory and non-inflammatory lesions over 12 weeks. While there were no significant differences in patient satisfaction or quality of life between the two treatments and both were well-tolerated, there were numerically about double the number of treatment-related adverse events with Tazorac (5.6 percent with Tazorac versus 2.9 percent with Arazlo).

Mechanism of Action

Arazlo (tazarotene) is a retinoid prodrug which is converted to its active form, tazarotenic acid, the carboxylic acid of tazarotene, by deesterification. Tazarotenic acid binds to all three members of the retinoic acid receptor (RAR) family: RARα, RARβ and RARγ, but shows relative selectivity for RARβ, and RARγ and may modify gene expression. The clinical significance of these findings for the treatment of acne vulgaris is unknown.