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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First Topical Androgen Inhibitor Tested to Fight Acne

This document was completed by Martina Cartwright, PhD Senior Director, Medical Affairs and Dr. Alessndro Mazzetti, Chief Medical Officer, Cassiopea.  The product being discussed, clascoterone cream 1% is NOT FDA approved and is for informational purposes only.

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

Response: Androgens play a significant role in the development of acne in both males and females. Oral medications that reduce androgens are used to treat acne in females, but due to side effects, are unsuitable for males.  Clascoterone cream 1% is a novel, topical androgen receptor inhibitor under FDA review as possibly a new first in class treatment for acne in both males and females.  These pivotal phase 3 studies demonstrated favorable efficacy and safety with low adverse event rates. 

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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Study Finds Chromophore Gel-Assisted Blue Light Phototherapy Improves Acne

This new study if a follow up of a study evaluating the KLOX BioPhotonic System, an LED blue light device using photo-converter chromophores, that demonstrated ” significantly improved moderate and severe facial acne vulgaris with an excellent safety profile”.

The current study extended the findings an additional 12 weeks and found ” The BioPhotonic System, which is comprised of LED blue light phototherapy and photo-converter chromophores, provides long-term efficacy and safety in the treatment of acne vulgaris, with a rate of compliance above what is generally observed in a young population of patients suffering from acne vulgaris, especially in light of sequential enrollment in a study treating one hemiface.”

 

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

Nikolis, A., Fauverghe, S., Scapagnini, G., Sotiriadis, D., Kontochristopoulos, G., Petridis, A., Rigopoulos, D., Dessinioti, C., Kalokasidis, K. and Antoniou, C. (2017), An extension of a multicenter, randomized, split-face clinical trial evaluating the efficacy and safety of chromophore gel-assisted blue light phototherapy for the treatment of acne. Int J Dermatol. doi:10.1111/ijd.13814

Possible Link Between Adolescent Acne and Later Life Prostate Cancer

A Swedish study found #that men with acne had a statistically signicant increased risk of prostate cancer later in life compared with men without acne”.  The link between the two may be the acne-associated bacteria Propionibacterium acnes.

Here is the link to the article:

Acne in Late Adolescence and Risk of Prostate Cancer
International Journal of Cancer

Study Finds Alcohol Intake Associated With Rosacea in Women

This study from the Department of Dermatology, Warren Alpert Medical School, Brown University finds “Alcohol intake was significantly associated with an increased risk of rosacea in women”.

J Am Acad Dermatol. 2017 Jun;76(6):1061-1067.e2. doi: 10.1016/j.jaad.2017.02.040. Epub 2017 Apr 20.

Alcohol intake and risk of rosacea in US women.

Li S1, Cho E2, Drucker AM3, Qureshi AA2, Li WQ4.

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

Acne Affects Over 50% Of European Young Adults

A recent study finds that “the overall prevalence of self-reported acne was 57.8% and was highest in the 15- to 17-year-old age group” with heredity as the main risk factor for developing acne.

Journal of the European Academy of Dermatology and Venereology: JEADV

Acne Prevalence and Associations With Lifestyle: A Cross-Sectional Online Survey of Adolescents/Young Adults in 7 European Countries

J Eur Acad Dermatol Venereol 2017 Sep 06;[EPub Ahead of Print], P Wolkenstein, A Machovcová, JC Szepietowski, D Tennstedt, S Veraldi, A Delarue

What Is Acne Keloidalis?

A keloid is a type of scar, that continues to grow and often itch, well after the underlying wound has healed.

Acne keloidalis is a type of scarring reaction most often seen on the nape of the neck or scalp.  Acne keloidalis may develop after a ‘close shave’ where the hairs have a chance to ingrow and cause inflammation and then scar.

Here’s a good case report:

Acne keloidalis nuchae: clinical and dermoscopic features

Chourouk ChoukNoureddine LitaiemMariem JonesFaten Zeglaoui
BMJ Case Reports 2017:published online 23 September 2017doi:10.1136/bcr-2017-222222

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

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