FDA Approves ARAZLO (tazarotene) Lotion to Fight Acne

FightAcne.com Interview with:
Dr. Emil A. Tanghetti.  M.D.
Center for Dermatology and Laser Surgery
Sacramento, California

Dr. Emil A. Tanghetti. M.D. Center for Dermatology and Laser Surgery Sacramento, California
Dr. Tanghetti

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.

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Fight Acne: The Influence of Social Media

FightAcne.com Interview with:
Zachary Zinn, MD
Assistant Professor
J.W. Ruby Memorial Hospital, WVU Medicine Children’s
Residency Program DirectorDepartment of Dermatology
Health Sciences Center
Morgantown, WV 
 Dr. Zinn is a member of the Society for Pediatric Dermatology

FightAcne.com:  What is the background for this study?

Response: We noticed that many patients used acne products based on social media recommendations, oftentimes without therapeutic success.  Our goal was to better understand the influence of social media on acne treatment.   This was a survey-based study given to patients presenting to an academic dermatology practice.

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FDA Approves Ortho Dermatologics’ ARAZLO (Tazarotene) Lotion, 0.045%, For Acne Vulgaris

FightAcne.com Interview with:
Emil Tanghetti, M.D., FAAD

Center for Dermatology and Laser Surgery
Sacramento, California

FightAcne.com:  What is the background for this study?  What are the main findings?

Response: This new tazarotene lotion is a game changer, by enhancing the delivery of the active drug with the polymeric lotion vehicle we are able to get efficacy that is similar to the higher concentration of tazarotene. This vehicle also permits the simultaneous delivery of emollients and humectants. Both these factors provide a much better tolerability profile than the older preparations. The main impediment in the past to using tazarotene was irritation. With this new formulation, this concern is no longer of paramount importance. This vehicle is cosmetically elegant and highly spreadable, which should make it an ideal product for the face, chest and back.

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Pediatric Acne Microbiome Differs From Older Teens

‘The predominant bacteria in microbiome studies of adult acne is Propionibacterium, whereas in this pediatric population we saw a lot of Streptococcus bacteria. After treatment, the microbiomes of intervention group participants more closely resembled those of control group participants.’

 

Coughlin CC, Swink SM, Horwinski J, et al. The preadolescent acne microbiome: A prospective, randomized, pilot study investigating characterization and effects of acne therapy. Pediatr Dermatol. 2017;00:14. https://doi.org/10.1111/pde.13261

 http://onlinelibrary.wiley.com/doi/10.1111/pde.13261/abstract?campaign=wolearlyview