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E-BPO for rosacea

Innovative microencapsulation technology gradually releases benzoyl peroxide (BPO)1-3

EPSOLAY microencapsulation technology icon white

Watch as dermatologist Dr. Hilary Baldwin discusses the state-of-the-art technology that makes EPSOLAY cream the first and only topical proven to control the release of BPO to relieve the inflammatory lesions of rosacea.1-4

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Discover the benefits of E-BPO for rosacea

  • Illustration of microencapsulation technology shell
    BUILT-IN BARRIER1,3

    Microencapsulation technology features a shell structure made from layers of silicon dioxide

    BPO, the active ingredient, is encapsulated at the core (ie, E-BPO)

    When applied, the shells create a barrier between the skin and the BPO

  • Illustration of microencapsulation release
    CONTROLLED RELEASE3

    Silica encapsulation controls the BPO release rate, allowing for gradual release over time

  • Illustration of microencapsulation absorption
    TOLERABLE RELIEF3

    The controlled release of BPO over time allows for efficacious yet tolerable relief of inflammatory lesions of rosacea

    LEARN MORE

The precise mechanism of action of BPO in the treatment of the inflammatory lesions of rosacea is unknown1

BPO is a trusted compound with complementary properties that are thought to effectively treat papulopustular rosacea.1,5-7

Sphere showing microencapsulation technology close up
POTENTIAL Anti-inflammatory effects6

BPO blocks production of reactive oxygen species

BPO reduces neutrophils that have been implicated in the inflammation of rosacea

POTENTIAL Antimicrobial Effects1,8

BPO is converted into benzoic acid in the skin and releases free-radical oxygen, which leads to the killing of bacteria

NO ANTIBIOTIC RESISTANCE1

BPO is not an antibiotic and does not cause antibiotic resistance

References: 1. EPSOLAY (benzoyl peroxide) cream, 5% [Prescribing Information]. Whippany, NJ: Sol-Gel Technologies Ltd.; April 2021. 2. Data on File. Galderma Laboratories, L.P. 3. Galderma Laboratories, L.P.; data on file. Clinical Study Report SGT-54-01; January 8, 2020. 4. Leyden JJ. Randomized, phase 2, dose-ranging study in the treatment of rosacea with encapsulated benzoyl peroxide gel. J Drugs Dermatol. 2014;13(6):685-688. 5. Zaenglein AL, Pathy AL, Schlosser BJ, et al. Guidelines of care for the management of acne vulgaris. J Am Acad Dermatol. 2016;74(5):945-973. doi:10.1016/j.jaad.2015.12.037 6. Jalian HR, Takahashi S, Kim J. Overview of dermatological diseases. In: Taylor JB, Triggle DJ, eds. Comprehensive Medicinal Chemistry II. Elsevier Ltd; 2007:935-955. 7. Oztürkcan S, Ermertcan AT, Sahin MT, Afşar FS. Efficiency of benzoyl peroxide-erythromycin gel in comparison with metronidazole gel in the treatment of acne rosacea. J Dermatol. 2004;31:610-617. doi:10.1111/j.1346-8138.2004.tb00566.x 8. Worret WI, Fluhr JW. Acne therapy with topical benzoyl peroxide, antibiotics and azelaic acid. J Dtsch Dermatol Ges. 2006;4:293-300. doi:10.1111/j.1610-0387.2006.05931.x

IMPORTANT SAFETY INFORMATION

Indication: EPSOLAY® (benzoyl peroxide) Cream, 5% is indicated for the treatment of inflammatory lesions of rosacea in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with EPSOLAY Cream were pain, erythema (redness), pruritus (itching) and edema (swelling), all at the application site. Warnings/Precautions: Patients using EPSOLAY Cream may experience hypersensitivity reactions, including anaphylaxis (acute allergic reaction), angioedema (rapid swelling), and urticaria (hives). If serious hypersensitivity reaction occurs, discontinue use of EPSOLAY Cream immediately and seek medical attention/initiate appropriate therapy. Skin Irritation/contact dermatitis may be experienced, including erythema (redness), scaling, dryness, and stinging/burning. Irritation and contact dermatitis may occur. Use a moisturizer and discontinue EPSOLAY Cream if symptoms do not improve. Avoid application to cuts, abrasions, eczematous, or sunburned skin. EPSOLAY Cream may increase photosensitivity, sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment). Use sunscreen or protective clothing when sun exposure cannot be avoided. Discontinue use of EPSOLAY Cream at the first evidence of sunburn.

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

IMPORTANT SAFETY INFORMATION

Indication: EPSOLAY® (benzoyl peroxide) Cream, 5% is indicated for the treatment of inflammatory lesions of rosacea in adults. Adverse Events: The most common adverse reactions (incidence ≥ 1%) in patients treated with EPSOLAY Cream were pain, erythema (redness), pruritus (itching) and edema (swelling), all at the application site. Warnings/Precautions: Patients using EPSOLAY Cream may experience hypersensitivity reactions, including anaphylaxis (acute allergic reaction), angioedema (rapid swelling), and urticaria (hives). If serious hypersensitivity reaction occurs, discontinue use of EPSOLAY Cream immediately and seek medical attention/initiate appropriate therapy. Skin Irritation/contact dermatitis may be experienced, including erythema (redness), scaling, dryness, and stinging/burning. Irritation and contact dermatitis may occur. Use a moisturizer and discontinue EPSOLAY Cream if symptoms do not improve. Avoid application to cuts, abrasions, eczematous, or sunburned skin. EPSOLAY Cream may increase photosensitivity, sensitivity to ultraviolet light. Minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment). Use sunscreen or protective clothing when sun exposure cannot be avoided. Discontinue use of EPSOLAY Cream at the first evidence of sunburn.

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

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STUDY DESIGN3

The safety and efficacy of EPSOLAY cream was evaluated in 2 multicenter, randomized, double-blind, vehicle-controlled trials in patients with moderate to severe papulopustular rosacea. In Pivotal Trial 1, 243 patients used EPSOLAY cream and 118 used vehicle cream. In Pivotal Trial 2, 250 patients used EPSOLAY cream and 122 used vehicle cream.

Patients were treated once daily for 12 weeks with either EPSOLAY cream or vehicle cream.

Patients were required to have a minimum of 15 to 70 total inflammatory lesions (papules and/or pustules) and no more than 2 nodules (where a nodule was defined as a papule or pustule greater than 5 mm in diameter) and an Investigator Global Assessment (IGA) score of 3 (moderate) or 4 (severe) at baseline.

At baseline, patients had a mean inflammatory lesion count of 27.5, 89% were scored as moderate (IGA=3), and 11% scored as severe (IGA=4).

The coprimary efficacy endpoints in both trials were the proportion of patients with treatment success at Week 12, defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-grade reduction from baseline, and the absolute change from baseline in inflammatory lesion counts at Week 12.

STUDY DESIGN4

The long-term safety and tolerability of daily use of EPSOLAY cream were evaluated in an open-label, long-term safety study in papulopustular rosacea patients from the 2 double-blind pivotal trials. A total of 547 patients were enrolled, including 363 patients previously treated with EPSOLAY cream and 184 patients previously treated with vehicle cream.

Patients were treated with EPSOLAY cream once daily from baseline through Week 40 with an IGA score for rosacea assessed as mild, moderate, or severe. If a patient was assessed as clear or almost clear, patients were not dispensed the study product until relapse was assessed.

Patients were required to have completed 12 weeks or be within the Week 12 window time (±4 days) of the double-blind treatment period of the pivotal trials and missed not more than 1 visit of Visits 3, 4, or 5 in the pivotal trials.

At baseline, patients had a mean inflammatory lesion count of 28.4, 89.2% were scored as moderate (IGA=3), and 10.8% were scored as severe (IGA=4).

Safety was evaluated by monitoring adverse events, cutaneous safety (dryness and scaling), and local tolerability (itching and burning/stinging) assessments, physical examinations, and vital signs. The study was not intended to assess efficacy. Certain efficacy data and endpoints were, however, summarized.

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