A New Tazarotene 0.045% Lotion Formulation for Moderate-to-Severe Acne: Efficacy and Safety in Phase 2 and Phase 3 Clinical Trials

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

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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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YouTube Inundated with Bloggers Giving Advice on How to Fight Acne

FightAcne.com Interview with:
Melissa Nickles BA
University of Illinois at Chicago College of Medicine
Chicago, IL

Melissa Nickles BA

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

Response: In today’s age, social media is becoming a growing force on our daily lives. This impacts healthcare in numerous ways. Many patients obtain health information, either knowingly or unknowingly, from social media. Teenageers are particularly vulnerable to misinformation on social media. Given the prevalence of health information provided on social media, oftentimes from non-professional sources, we chose to evaluate recommendations for acne therapies on YouTube.

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New Antibiotic Used to Fight Acne May Also Work for Perioral Dermatitis

FightAcne.com Interview with:
Emmy Graber, MD, MBA
President, The Dermatology Institute of Boston
Affiliate Clinical Instructor, Northeastern University

Dr. Emily Graber

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

Response:     Periorificial dermatitis (POD) is an eczematous-like eruption of erythematous papules and pustules around the orifices of the face such as the mouth, nose or eyes. Typically, treatment involves discontinuation of the offending agent, if any, as well as administration of oral doxycycline. However, doxycycline is a broad-spectrum tetracycline that may result in pronounced gastrointestinal side effects, especially in patients with inflammatory bowel disease (IBD) as well as potentially cause gut flora dysbiosis (disruption of the gut microbiome).

In this case report, a patient seeking treatment for POD also has underlying Crohn’s disease. Sarecycline, a narrow-spectrum tetracycline, was used with careful consideration due to the patient’s underlying IBD. The hope was that sarecycline would have a similar effect on POD as doxycycline, without the side effects associated with broad-spectrum antibiotics.

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Winlevi: Breakthrough New Cream to Fight Acne

FightAcne.com Interview with:
Michael H. Gold, M.D. FAAD
Medical Director
Gold Skin Care Center
Tennessee Clinical Research Center

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

Response: What is the background for this study? Acne is a very prevalent disease; in fact, it is the most common thing seen in dermatologists’ offices across the country.  We have not had a novel topical acne medication to treat both the inflammatory (papules and pustules) as well as the non-inflammatory acne (whiteheads and blackheads) for many years. 

Clascoterone cream (1%) is that new breakthrough topical that we have been waiting for and has a unique mechanism of action in that it targets the androgen receptors in the skin.  This unique treatment opportunity is the first new compound in over 40 years for dermatologists.

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Benefits and Side Effects of Microneedling to Fight Acne

FightAcne.com Interview with:
Miesha Merati, DO, FAAD
The Parker Skin and Aesthetic Clinic
Beachwood, Ohio

FightAcne.com: Would you briefly explain the microneedling procedure and what it is used for?

Response: Microneedling has gained popularity over the recent years due to its accessibility, relative ease of use, and impressive results for a variety of skin concerns including scar remodeling, pigmentary disorders, alopecia, acne, rejuvenation and rhytide reduction. It is a minimally invasive procedure that uses a device with needles ranging from 0.5 to 3mm in length that puncture the epidermis, and sometimes the dermis in a controlled fashion. Penetration of the skin allows for the release of growth factors, collagen, elastin, and dermal drug delivery. Microneedling exists in many forms, including the roller device, dermastamp, automated pen, and fractional radiofrequency. 

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Acne Risk in Transgender Patients Receiving Testosterone Therapy

FightAcne.com Interview with:
Erica Dommasch, MD, MPH
Department of Dermatology
Assistant Professor
Harvard Medical School

Dr. Dommasch

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

Response: Prior studies have suggested that testosterone use among transgender/gender minority patients may be linked to the development of acne, but they have been limited by small patient populations and have had varying conclusions. Acne can be a debilitating condition for many patients but may be especially harmful for transgender patients who already experience stigma and discrimination.

FightAcne.com: What are the main findings?

Response: We conducted a large, retrospective cohort study including 988 transgender patients who newly initiated testosterone to examine the incidence and predictors of acne in this population.

We found that after 2 years, 25% of these patients developed a new diagnosis of acne.  This risk was highest among the youngest age group in our study (age 18 to 20.75 years), with 29.6% of these patients developing acne over 2 years.

Off-Label Spironolactone Can Fight Acne of Face, Chest and Back in Women

FightAcne.com Interview with:
John S. Barbieri MD MBA
University of Pennsylvania
Philadelphia, PA 19104

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

Response: Spironolactone is used off-label for the treatment of acne in women. However, data on its effectiveness is limited to small trials and retrospective studies that often use subjective, qualitative outcomes. As a result, we sought to characterize the effectiveness of spironolactone for acne in routine clinical practice, using objective, quantitative outcomes such as the Comprehensive Acne Severity Scale. We also evaluated acne both on the face and also on the chest and back.

FightAcne.com: What are the main findings?

Response: We found that spironolactone is effective for both acne on the face as well as for acne on the chest and back. Similar to prior studies, we found that spironolactone can take a few months to reach peak effectiveness, so patience is importance when starting treatment with spironolactone. We found that doses 100mg/day or higher tended to be better than lower doses. 

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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.

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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