Novel Polymeric Tazarotene 0.045% Lotion for Moderate-to-Severe Acne: Pooled Phase 3 Analysis by Race

FightAcne.com Interview with:
Dr. Linda Stein Gold MD

Director, Dermatology Clinical Research
Henry Ford Health System

Dr. Stein Gold: Patients of color have an increased risk of acne and inflammation-related sequalae, including post-inflammatory hyperpigmentation (PIH) associated with acne resolution or irritation from treatment. Traditional topical retinoids, such as tazarotene, treat acne by inhibiting multiple inflammatory pathways and normalizing desquamation. However, skin irritation and other skin reactions may limit the use of some tazarotene gel and cream formulations. However, ARAZLO, a low dose tazarotene 0.045% lotion approved in 2020 utilizes polymeric emulsion technology, which makes it a highly spreadable lotion that allows for efficient delivery of tazarotene into dermal layers while reducing the potential for skin irritation.

In two phase 3, double-blind, 12-week studies, participants with moderate-to-severe acne were randomized 1:1 to tazarotene 0.045% lotion or vehicle lotion. This pooled, post hoc analysis included subsets of participants segmented by white or black race. Coprimary endpoints were inflammatory/noninflammatory lesion counts and treatment success, which was defined by at least a 2-grade reduction from baseline in the Evaluator’s Global Severity Score (EGSS) and an EGSS that was “clear” or “almost clear.” Treatment-emergent adverse events (TEAEs) and cutaneous safety and tolerability were also evaluated.

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Study Finds Tazarotene 0.045% Lotion Improved Both Acne and Hyperpigmentation in Black Patients

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?

ResponsePatients 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.

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