OPEN-LABEL TRUNCAL STUDY

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OPEN-LABEL TRUNCAL STUDY

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Unique Formulation

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EXPLORE THE UNIQUE MECHANISM OF DELIVERY FOR ARAZLO POLYMERIC MESH TECHNOLOGY

Watch and learn how patented polymeric emulsion technology distributes tazarotene evenly to help reduce irritation, and facilitates rapid absorption of hydrating excipients that can strengthen barrier function, to deliver the clearance you expect and the tolerability you want1-5

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Even Distribution

Formulated to help distribute evenly and reduce irritation1

The vehicle in ARAZLO Lotion features a honeycomb mesh that spreads tazarotene evenly on the skin.1

The clinical significance of the formulation has not been established.The ARAZLO Lotion vehicle comprises the inactive ingredients.

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When applied, the honeycomb mesh distributes the oil droplets evenly on the skin1

The oil droplets are trapped within the ARAZLO Lotion patented honeycomb mesh1

Tazarotene is encapsulated within oil droplet1

Barrier Function

Improves barrier function2

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In addition to the tazarotene-containing oil droplets, the honeycomb mesh evenly distributes hydrating components that form a barrier to help keep the skin from losing moisture.1

  • 8 hours after vehicle application the skin barrier was 51% more effective at retaining water than at baseline2
Study design
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The transepidermal water loss (TEWL) and moisture content of skin sites treated with ARAZLO Lotion vehicle vs untreated sites were measured in 30 healthy people at baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 8 hours, and 24 hours. Evaluations were made by a trained technician using the tewameter and corneometer.2

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Improves water retention2

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  • 15 and 30 minutes after vehicle application, there was 107% more water in the skin than at time 0 as measured by corneometry2
  • 24 hours after application, the water content in the skin was 38% greater than at baseline2
Study design
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The transepidermal water loss (TEWL) and moisture content of skin sites treated with ARAZLO Lotion vehicle vs untreated sites were measured in 30 healthy people at baseline, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 8 hours, and 24 hours. Evaluations were made by a trained technician using the tewameter and corneometer.2

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Patient Friendly

Designed with polymeric technology and hydrating ingredients1

Excipients with hydrating properties include1:

  • Diethyl sebacate
  • Light mineral oil
  • Sorbitol solution, 70%

In a survey, 100% of patients (N=15) strongly agreed or agreed
that the ARAZLO Lotion vehicle had these qualities1,2:

  • Absorbed quickly
  • Did not feel greasy
  • Had a lightweight after-feel
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Study design
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15 healthy females between the ages of 35 and 65 applied the assigned lotion vehicle to the right side of their faces while leaving the left side untreated. Afterward, they answered a questionnaire to assess their satisfaction.2

Indication

ARAZLO® (tazarotene) Lotion, 0.045% is indicated for the topical treatment of acne vulgaris in patients 9 years of age and older.

Important Safety Information

ARAZLO Lotion is for topical use only. Not for oral, ophthalmic, or intravaginal use.

Contraindication

ARAZLO Lotion is contraindicated in pregnancy due to the potential harm to the fetus.

Warnings and Precautions

Embryofetal Risk Females of childbearing potential should be warned of the potential risk and use adequate birth-control measures when ARAZLO Lotion is used. A negative result for pregnancy should be obtained within 2 weeks prior to ARAZLO Lotion therapy. ARAZLO Lotion therapy should begin during a menstrual period.

Skin Irritation Patients using ARAZLO Lotion may experience application site pain, dryness, exfoliation, erythema, and pruritus. Depending upon severity of these adverse reactions, instruct patients to use a moisturizer, reduce the frequency of the application of ARAZLO Lotion, or discontinue use. Therapy can be resumed, or the frequency of application can be increased, as the patient becomes able to tolerate treatment. Avoid application of ARAZLO Lotion to eczematous or sunburned skin.

Ultraviolet Light and Environmental Exposure Minimize unprotected exposure to ultraviolet light, including sunlight and sunlamps, during the use of ARAZLO Lotion. Warn patients who normally experience high levels of sun exposure and those with inherent sensitivity to sun to exercise caution. Use sunscreen products and protective clothing over treated areas when sun exposure cannot be avoided. ARAZLO Lotion should be administered with caution if the patient is also taking drugs known to be photosensitizers (eg, thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of the increased possibility of augmented photosensitivity. Weather extremes, such as wind or cold, may be more irritating to patients using ARAZLO Lotion.

Adverse Reactions The most common adverse reactions (in ≥1% of patients and greater than vehicle) were: pain, dryness, exfoliation, erythema, and pruritus (all at application site).

To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health US, LLC at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Please click here for full Prescribing Information.

References: 1. ARAZLO Lotion [prescribing information]. Bridgewater, NJ. Bausch Health US, LLC. 2. 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. 3. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. Accessed October 10, 2019. 4. Data on file.

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