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.

FightAcne.com: What are the main findings? 

Dr. Stein Gold: In both phase 3 studies, tazarotene 0.045% lotion demonstrated efficacy in the treatment of moderate-to-severe acne in both white and black participants. In white participants, tazarotene was significant versus vehicle for all 3 efficacy assessments. In black participants, only reduction in noninflammatory lesions was significant for tazarotene versus vehicle. This formulation of tazarotene was well tolerated compared with vehicle lotion, and treatment with tazarotene lotion led to improvements in inflammation-associated sequelae of acne, including hyperpigmentation.

FightAcne.com: What should readers take away from your report? 

Dr. Stein Gold: Tazarotene 0.045% lotion may be an effective and well tolerated treatment option for acne in patients of color because this study demonstrated a low incidence of the skin irritation usually associated with retinoids.

FightAcne.com: What recommendations do you have for future research? 

Dr. Stein Gold:The small sample size among black participants may have limited the statistical analysis of treatment success, so I would recommend that future research increase the sample size of the black subset of the participants studied.

Important Safety Information

What is ARAZLO?

ARAZLO™ (tazarotene) Lotion, 0.045% is a prescription medicine used on the skin (topical) to treat people 9 years of age and older with acne, which can include blackheads, whiteheads, and other pimples.

It is not known if ARAZLO is safe and effective in children under 9 years of age.

Important Safety Information

ARAZLO is for use on skin only. Do not use ARAZLO in your eyes, mouth, the corners of your nose, or vagina.

What is the most important information I should know about ARAZLO?
  • ARAZLO may cause birth defects if used during pregnancy.
  • You must not be pregnant when you start using ARAZLO or become pregnant during treatment.
  • Use effective birth control during treatment.
  • Stop using ARAZLO and tell your healthcare provider right away if you become pregnant during treatment.
Before using ARAZLO, tell your healthcare provider about all your medical conditions, including if you:
  • have eczema or any other skin problems.
  • are breastfeeding or plan to breastfeed. If you use ARAZLO while breastfeeding, use it for the shortest time needed. Do not apply ARAZLO directly to the nipple and surrounding area to avoid exposing your child to the medicine.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines can make your skin more sensitive to sunlight; ask your healthcare provider for a list of medicines if you are not sure.

Especially tell your healthcare provider about other products you use on your skin (such as benzoyl peroxide), including moisturizers, creams, lotions, or products that can dry out your skin.

What should I avoid while using ARAZLO?
  • You should avoid sunlamps, tanning beds, and ultraviolet light during treatment with ARAZLO.
  • Minimize exposure to sunlight; you could get severe sunburn.

If you have to be in the sunlight or are sensitive to sunlight, use a sunscreen with an SPF (sun protection factor) of 15 or more and wear protective clothing and a wide-brimmed hat to cover the treated areas.

  • Avoid using ARAZLO on skin with eczema or sunburned skin because it may cause severe irritation.
ARAZLO may cause side effects, including:

Skin irritation. ARAZLO may cause irritation including skin dryness, pain, redness, excessive flaking or peeling. If you develop these symptoms, your healthcare provider may tell you to use a moisturizer, adjust the dosing, or completely stop treatment with ARAZLO.

These are not all the possible side effects of ARAZLO. Call your doctor for medical advice about side effects. You may report side effects to Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088.

Click here for full Prescribing Information, including Patient Information.

The information on FightAcne.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

The information on FightAcne.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.