Important safety information

PrARAZLOTM (tazarotene lotion, 0.045%) is indicated for the topical treatment of acne vulgaris in patients 10 years of age and older.1

Clinical use:
■ Safety and efficacy of ARAZLO have not been established in geriatrics (>65 years of age).
■ Patients 10 to <12 years of age should limit application of ARAZLO to the face.
 
Contraindications:
■ Hypersensitivity to retinoic compounds
■ Pregnant women or women who may become pregnant
■ Should not be used in the presence of seborrheic dermatitis
 
Relevant warnings and precautions:
■ For external topical use only
■ Application site pain, dryness, exfoliation, erythema, and pruritus
■ Use of topical tazarotene may produce contact dermatitis
■ Avoid concomitant use of medications and cosmetics that have a strong drying effect
■ Avoid application to eczematous or sunburned skin
■ Photosensitivity
■ Caution with coadministration of drugs known to be photosensitizers
■ Use adequate birth-control measures in women of childbearing potential
■ Discontinue treatment if patient becomes pregnant
■ Breastfeeding
 
For more information:
Please see the Product Monograph here for important information on adverse reactions, drug interactions and dosing not discussed in this piece. The Product Monograph is also available by calling 1-800-361-4261.

Now available on many provincial formularies
(criteria may apply)

Click here to see where ARAZLO is covered
Treating acne with ARAZLO

ARAZLO (tazarotene lotion, 0.045%) is indicated for the topical treatment of acne vulgaris in patients 10 years of age and older.1

Efficacy Data

ARAZLO demonstrated efficacy in all co-primary endpoints at week 12 in two large vehicle-controlled clinical trials1†

ARAZLO showed significantly greater mean percent reduction in inflammatory lesion count at week 12 from baseline vs. vehicle (secondary endpoint)1

  • Inflammatory lesions
  • Non-inflammatory lesions
  • EGSS results

Mean percent reduction in inflammatory lesion count at weeks 8 and 12 (secondary endpoints)1,2

Both studies met 6 out of 7 secondary efficacy endpoints. However, the difference between treatment groups at week 4 in inflammatory lesion counts was not significant.†

† Two identical prospective, randomized, multicenter, double-blind, parallel-group, vehicle-controlled, Phase 3 clinical trials compared ARAZLO lotion (n=402 and n=397 in studies 1 and 2, respectively) with the vehicle lotion (n=411, n=404), in patients aged 9 years and older with moderate to severe acne. Co-primary efficacy endpoints included treatment success on the Evaluator’s Global Severity Score (EGSS) and absolute change in non-inflammatory and inflammatory lesion counts at week 12. Secondary endpoints included percentage change in non-inflammatory and inflammatory lesion counts at weeks 12, 8 and 4, and proportion of subjects with at least a 2-grade reduction from baseline in EGSS at week 12.

Mean percent reduction in non-inflammatory lesion count at weeks 4, 8 and 12 (secondary endpoints)1,2

Both studies met 6 out of 7 secondary efficacy endpoints. However, the difference between treatment groups at week 4 in inflammatory lesion counts was not significant.†

† Two identical prospective, randomized, multicenter, double-blind, parallel-group, vehicle-controlled, Phase 3 clinical trials compared ARAZLO lotion (n=402 and n=397 in studies 1 and 2, respectively) with the vehicle lotion (n=411, n=404), in patients aged 9 years and older with moderate to severe acne. Co-primary efficacy endpoints included treatment success on the Evaluator’s Global Severity Score (EGSS) and absolute change in non-inflammatory and inflammatory lesion counts at week 12. Secondary endpoints included percentage change in non-inflammatory and inflammatory lesion counts at weeks 12, 8 and 4, and proportion of subjects with at least a 2-grade reduction from baseline in EGSS at week 12.

Percentage of patients with treatment success on the EGSS at week 12

Treatment success was defined as percentage of patients with ≥2-grade improvement from baseline and an Evaluator’s Global Severity Score (EGSS) of clear (normal, clear skin with no evidence of acne vulgaris) or almost clear (rare non-inflammatory lesions and papules) at week 12.

EGSS: Evaluator’s Global Severity Score
† Two identical prospective, randomized, multicenter, double-blind, parallel-group, vehicle-controlled, Phase 3 clinical trials compared ARAZLO lotion (n=402 and n=397 in studies 1 and 2, respectively) with the vehicle lotion (n=411, n=404), in patients aged 9 years and older with moderate to severe acne. Co-primary efficacy endpoints included treatment success on the Evaluator’s Global Severity Score (EGSS) and absolute change in non-inflammatory and inflammatory lesion counts at week 12.
Patient Cases

Patient results from pivotal clinical trials3

Safety Profile

A demonstrated cutaneous safety and tolerability profile1

Common adverse reactions were:

  • Application site pain (5.3%)
  • Application site exfoliation (2.1%)
  • Application site pruritus (1.3%)
  • Application site dryness (3.9%)
  • Application site erythema (1.9%)
  • Viral upper respiratory tract infection (4.6%)
  • Upper respiratory tract infection (1.7%)
Tolerability Assessments

Cutaneous safety and tolerability assessments1

The cutaneous safety and tolerability of ARAZLO were evaluated through active assessments of the following parameters† at the application site:
  • Scaling
  • Erythema
  • Itching
  • Burning
  • Stinging
  • Hypopigmentation
  • Hyperpigmentation
  • Overall, the incidence and mean scores of erythema, scaling, burning, stinging and itching were higher for ARAZLO vs. vehicle at any postbaseline visit.
  • Symptoms were generally mild to moderate, showing transient increases in severity that peaked around week 2 and improved over the course of the study.
  • At week 12, most patients showed small changes from baseline in nearly all assessed parameters.
Please see the Product Monograph for complete information on incidence of cutaneous safety and tolerability parameters.
† Cutaneous safety and tolerability parameters were evaluated at each study visit. Severity of the parameters was graded as none, mild, moderate or severe.
PrismatrexTM Technology

Get to know ARAZLO lotion

A lightweight, non-greasy lotion1†

ARAZLO lotion contains known hydrating and moisturizing ingredients such as diethyl sebacate, light mineral oil and sorbitol solution, which may alleviate dryness of skin.†
  • The PrismatrexTM polymeric emulsification system maintains the emulsion droplets size distribution stable across time and temperature.
  • This system provides stable emulsions by anchoring its hydrophobic portions and forming an adsorbed gel layer around each oil droplet.
  • The target pH of 5.0-6.0 is controlled by the amount of polymer base (sodium hydroxide) present in the formulation.
  • This pH range is consistent with the pH tolerated by the skin without inducing irritation.

10,000X magnification of honeycomb mesh showing an emulsion droplet

† Comparative clinical significance is unknown.
Dosing & Administration

ARAZLO is applied once daily in 5 steps1

Discontinue treatment when control has been achieved. Treatment may be reinitiated as necessary. Intermittent use should be the least number of applications that will prevent recurrence of acne.1
Summary

Think ARAZLO for your acne patients 10 years and older1

  • ARAZLO showed 60% mean reduction in inflammatory lesion count at week 12 vs. 49% for vehicle (study 2; secondary endpoint)1
  • ARAZLO showed 60% mean reduction in non-inflammatory lesion count at week 12 vs. 42% of vehicle (study 2; secondary endpoint)1
  • 30% of ARAZLO-treated patients had treatment success on the EGSS at week 12 vs. 17% for vehicle (study 2; co-primary endpoint)1
  • ARAZLO had a demonstrated cutaneous safety and tolerability profile 1
    • The most common adverse events were application site pain (5.3%), viral upper respiratory tract infection (4.6%), application site dryness (3.9%), application site exfoliation (2.1%), and application site erythema (1.9%).
    • Symptoms were generally mild to moderate, showing transient increases in severity that peaked around week 2 and improved over the course of the study.
EGSS: Evaluator's Global Severity Score
Safety Information
Clinical use:
■ Safety and efficacy of ARAZLO have not been established in geriatrics (>65 years of age).
■ Patients 10 to <12 years of age should limit application of ARAZLO to the face.
 
Contraindications:
■ Hypersensitivity to retinoic compounds
■ Pregnant women or women who may become pregnant
■ Should not be used in the presence of seborrheic dermatitis
 
Relevant warnings and precautions:
■ For external topical use only
■ Application site pain, dryness, exfoliation, erythema, and pruritus
■ Use of topical tazarotene may produce contact dermatitis
■ Avoid concomitant use of medications and cosmetics that have a strong drying effect
■ Avoid application to eczematous or sunburned skin
■ Photosensitivity
■ Caution with coadministration of drugs known to be photosensitizers
■ Use adequate birth-control measures in women of childbearing potential
■ Discontinue treatment if patient becomes pregnant
■ Breastfeeding
 
For more information:
Please see the Product Monograph here for important information on adverse reactions, drug interactions and dosing not discussed in this piece. The Product Monograph is also available by calling 1-800-361-4261.
 
References: 1. ARAZLO Product Monograph. Bausch Health, July 7, 2021. 2. Tanghetti EA, Werschler WP, Lain T, et al. Tazarotene 0.045% lotion for once-daily treatment of moderate-to-severe acne vulgaris: results from two Phase 3 trials. J Drugs Dermatol. 2020;19(1):70-77. 3. Data on file. Bausch Health, 2021.
ARAZLOTM is a trademark of
Bausch Health Companies Inc.
or its affiliates.
Bausch Health, Canada Inc.
2150 St-Elzéar Blvd. West
Laval, Quebec H7L 4A8
© 2026 Bausch Health, Canada Inc.
All rights reserved.