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IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Skin Reactions: There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation. continue reading below ▾

For US healthcare professionals only

Finacea® Foam Efficacy

See the results at 12 weeks

Reduction in inflammatory lesion count

Mean nominal changes in inflammatory lesion count from baseline to end of 12-week treatment period1

Significant reduction in the mean number of inflammatory lesions with Finacea® Foam vs foam vehicle* at 12 weeks.2

* Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.1

IGA* success rates

Clinical results

  • Superior success rates with Finacea® Foam vs foam vehicle†1

IGA success rate from baseline to end of 12-week treatment period1

*Investigator's Global Assessment.

Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.1

IGA criteria »

Before-and-after photos from the clinical studies

Actual photo of a Finacea® Foam clinical trial subject. All patients may not exhibit the same results.

In 2 pivotal clinical studies, there was a significant reduction in the mean number of inflammatory lesions with Finacea® Foam vs foam vehicle* at 12 weeks.1

  • Trial 1: –13.2 (N=483) for Finacea® Foam versus –10.3 (N=478) for foam vehicle
  • Trial 2: –13.3 (N=198) for Finacea® Foam versus –9.5 (N=203) for foam vehicle

In 2 pivotal clinical studies, the IGA success rates of subjects treated with Finacea® Foam versus foam vehicle were1:

  • Trial 1: 32.1% (N=483) for Finacea® Foam versus 23.4% (N=478) for foam vehicle
  • Trial 2: 43.4% (N=198) for Finacea® Foam versus 32.5% (N=203) for foam vehicle

*Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.1

Investigator's Global Assessment.

Clinical studies

Study design1

  • Two pivotal, multicenter, randomized, double-blind, vehicle-controlled, 12-week clinical trials involving a total of 1,362 patients (active N=681; vehicle N=681)
  • Finacea® Foam was compared to its foam vehicle* without azelaic acid
  • Subjects' ages ranged from 19 to 92 years (mean age 50.6 years). 95.7% of subjects participating in the trials were Caucasian and 73.4% were female
  • Enrolled patients had papulopustular rosacea with a mean lesion count of 21.3 (range 12 to 50) inflammatory papules and pustules
  • Exclusion criteria:
    • Those with ocular rosacea, phymatous rosacea, or plaque-type rosacea lesions
    • Those with rosacea that requires systemic treatment
    • Those who are known nonresponders to azelaic acid
    • Those with a known hypersensitivity to any ingredients of the study drug
  • Finacea® Foam or the foam vehicle were to be applied twice daily for 12 weeks; no other topical or systemic medication affecting the course of rosacea and/or evaluability was to be used during the studies

The efficacy endpoints in the 2 clinical trials were:

Nominal change in inflammatory lesion count from baseline,

AND

success defined as a score of “Clear” or “Minimal” with at least a 2-step reduction from baseline on a 5-point IGA.

IGA (criteria used to define success)1

Success is defined as a score of “Clear” or “Minimal” with at least a 2-step reduction, “Moderate” to “Minimal,” from baseline on a 5-point IGA.1

Graphic representation is for illustrative purposes only.

*Foam vehicle contained the same exact hydrophilic foam minus azelaic acid.1

Investigator's Global Assessment.

References: 1. Finacea® Foam [prescribing information]. LEO Pharma Inc. 2. Data on file. LEO Pharma Inc.

Important Safety Information

Warnings and Precautions

Skin Reactions: There have been isolated reports of hypopigmentation after use of azelaic acid. Because azelaic acid has not been well studied in patients with dark complexion, monitor these patients for early signs of hypopigmentation.

Eye and Mucous Membranes Irritation: Azelaic acid has been reported to cause irritation of the eyes. Avoid contact with the eyes, mouth, and other mucous membranes. If Finacea® Foam does come in contact with the eyes, wash the eyes with large amounts of water and consult a healthcare professional if eye irritation persists.

Flammability: The propellant in Finacea® Foam is flammable. Instruct the patient to avoid fire, flame, and smoking during and immediately following application. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C).

Most Common Adverse Reactions

In clinical studies, the most frequently observed adverse reactions in ≥ 0.5% of subjects treated with Finacea® Foam included local site pain (6.2%), pruritus (2.5%), dryness (0.7%), and erythema (0.7%).

For Topical Use Only

Finacea® Foam is not for oral, ophthalmic, or intravaginal use.

Avoid the use of occlusive dressings or wrappings at the application site. Avoid use of alcoholic cleansers, tinctures and astringents, abrasives, and peeling agents.

Patients should be reassessed if no improvement is observed upon completing 12 weeks of therapy.

Indication

Finacea® (azelaic acid) Foam, 15% is indicated for topical treatment of the inflammatory papules and pustules of mild to moderate rosacea.

You are encouraged to report side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch, or call 1-800-FDA-1088 (1-800-332-1088).

For important risk and use information, see the full Prescribing Information.