FightAcne.com Interview with: Emil A. Tanghetti, MD ARAZLO study investigator Founder, Center for Dermatology and Laser Surgery Sacramento, California
FightAcne.com: What is the background for this study? How does ARAZLO™ differ from other forms of retinoids?
Dr. Tanghetti: Topical tazarotene 0.1% is approved for the treatment of acne vulgaris, though skin irritation and other skin reactions may limit use of some gel, foam, and cream formulations.1,2 Arazlo (tazarotene 0.045%) lotion was developed utilizing polymeric emulsion technology, allowing for rapid and uniform distribution of tazarotene, humectants, and moisturizers on the skin.1,2 This highly spreadable lotion formulation was developed to allow for more efficient delivery of tazarotene into dermal layers while reducing the potential for skin irritation.1,2
A phase 2 study and two phase 3 studies demonstrated the efficacy and safety of tarazarotene 0.045%.1
FightAcne.com Interview with: Dr. Fran Cook-Bolden, MD Diplomate of the American Board of Dermatology Director of FCB Dermatology and Wellness, Cosmetic & Laser Surgery and Clinical Assistant Professor, Weill Cornell, NY
FightAcne.com: What is the background for this study? What are the main findings?
Response: Patients with skin of color have a higher risk of acne and inflammation-related complications, including post-inflammatory hyperpigmentation (PIH). Topical retinoids such as tazarotene treat acne in part by reducing inflammation. However, skin irritation and other skin reactions may limit the use of some tazarotene gel and cream formulations. A lower-dose tazarotene 0.045% lotion formulation (Arazlo™, Ortho Dermatologics) was recently developed to treat acne.
FightAcne.com: How does Tazarotene Cream differ from other medication groups for acne?
Response:To clarify, our results are on tazarotene lotion, not tazarotene cream. Tazarotene 0.045% lotion is the first lotion formulation of tazarotene, which was created using polymeric emulsion technology. The benefits of this new technology are that the lotion is highly spreadable, and it allows for more efficient delivery of tazarotene deep into the skin while reducing the potential for skin irritation. In a previous study, tazarotene 0.045% lotion had comparable efficacy to tazarotene 0.1% cream but with fewer side effects.
FightAcne.com: What is the background for this announcement?
Response: ARAZLOTM (tazarotene) Lotion, 0.045%, was approved by the U.S. Food and Drug Administration in December 2019 and is indicated for the topical treatment of acne vulgaris in patients nine years of age and older. This week, Ortho Dermatologics announced that ARAZLO is available commercially to healthcare professionals.
FightAcne.com: What are the main findings of your study? : Tanghetti EA, Kircik LH, Green LJ, et. Al. A Phase 2 multicenter, double-blind, randomized, vehicle controlled clinical study to compare the safety and efficacy of a novel tazarotene 0.045% lotion and tazarotene 0.1% cream in the treatment of moderate-to-severe acne vulgaris. J Drugs Dermatol. 2019;18(6):542-548
Response: In this 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 about double the number of treatment-related adverse events with Tazorac (5.6% with Tazorac vs. 2.9% with ARAZLO).
Additionally, ARAZLO was evaluated in two Phase 3 multicenter, randomized, double-blind, vehicle-controlled clinical trials in 1,614 patients with moderate to severe acne. In both Phase 3 studies, ARAZLO showed superiority to vehicle for all primary efficacy endpoints (p<.001). ARAZLO was also shown to be generally well-tolerated in the clinical study population.
In the topical retinoid world, consensus and head-to-head studies all have strongly suggested that tazarotene 0.1% cream and gel is the most potent retinoid in this space. However, irritation has always been a concern and has been one of the main impediments to widespread use. ARAZLO provides the same efficacy of tazarotene 0.1% cream with a significantly better tolerability profile.