Tazarotene lotion shows positive phase 3 results

January 16, 2020

Recent phase 3 clinical trials reveal positive results for tazarotene lotion 0.045% in patients with moderate-to-severe acne.

Two phase 3 clinical trials of tazarotene lotion 0.045% (Arazlo, Ortho Dermatologics) suggest the topical could be helpful for the treatment of moderate-to-severe acne vulgaris, according to results published in the January issue of the Journal of Drugs in Dermatology.

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The topical, which was approved in December 2019 by the U.S. Food and Drug Administration (FDA), is the first approved tazarotene in lotion form for the treatment of acne vulgaris in patients nine years of age and older.

While tazarotene 0.1% gel, foam and cream has been proven to be an efficient treatment for acne, as with many retinoids, it’s also been found to cause irritation such as dryness, scaling, burning, erythema and pruritus, which can limit its usefulness.

To examine the safety, tolerability and efficacy of tazarotene in lotion form, both studies utilized polymetric emulsion technology, which employs a constant disbursement of humectants, moisturizing ingredients and active ingredients contained in micronized oil droplets to aid in the distribution into the epidermis. This lead to an increased tolerability while maintaining parallel efficacy to other vehicle formulations such as gels and foams.

During the double-blind, parallel, randomized, multicenter and placebo-controlled trials, 1,600 patients were randomized to receive either tazarotene 0.045% lotion or vehicle over 12 weeks.

Results from the studies show a statistically higher success rate for reducing inflammatory and noninflammatory lesions in those using tazarotene 0.045% compared to vehicle.  Mean percentages were 55.5% and 51.4% (Study 1, both P<0.001 versus vehicle [45.7% and 41.5%, respectively]) and 59.5% and 60.0% (Study 2, both P<0.001 versus vehicle [49.0% and 41.6%, respectively]), with tazarotene 0.1% cream at week 12.

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Study authors note that the drug was generally well-tolerated, with the most common treatment related adverse events being pain (5.3%), dryness (3.6%) and exfoliation (2.1%).

Both studies met all primary endpoints including absolute reduction in non-inflammatory and inflammatory lesions counts, and a minimum of a two-grade improvement in the Evaluator’s Global Severity Score (EGSS).

"[This] data, combined with our recent FDA approval of ARAZLO, demonstrate our continued commitment to bringing treatment innovations to market that meet the ever-evolving needs of dermatologists and their patients who struggle with acne," says Bill Humphries, president of Ortho Dermatologics. "We look forward to launching the product later this year, providing dermatologists with a lower concentration of tazarotene lotion that helps effectively clear moderate-to-severe acne."

 

References:

Tanghetti EA, Werschler WP, Lain TP, Guenin Eundefined, Martin Gundefined, PhDe Rundefined. Article. JDDonline. https://jddonline.com/articles/dermatology/S1545961620P0070X/1. Published January 2020. Accessed January 15, 2020.

Bausch Health Companies Inc. Ortho Dermatologics Announces Publication Of Pivotal Phase 3 Data On ARAZLO™ (tazarotene) Lotion, 0.045% In The Journal Of Drugs In Dermatology (JDD). PR Newswire: press release distribution, targeting, monitoring and marketing. https://www.prnewswire.com/news-releases/ortho-dermatologics-announces-publication-of-pivotal-phase-3-data-on-arazlo-tazarotene-lotion-0-045-in-the-journal-of-drugs-in-dermatology-jdd-300985477.html. Published January 13, 2020. Accessed January 15, 2020.